TW201945731A - Equipment for testing biological specimens and method of determining properties of the biological specimens - Google Patents

Abstract

The invention relates to an apparatus for testing a biological specimen, the apparatus comprising: a receiving mechanism to receive a carrier, wherein the carrier includes a holding area, wherein the holding area carriers or has been exposed to the biological specimen; a camera module arranged to capture imagery of the holding area; a processor that is configured to utilize the camera module to (1) identify, from the captured imagery of the holding area, a visual cue on the carrier, and (2) perform, based on a result of said identification of the visual cue, a set of analytic processes on the captured imagery, wherein the set of analytic processes includes: dividing the captured imagery into a plurality of segments; selecting, from the plurality of segments, candidate segments for analysis; and determining one or more properties of the biological specimen by analyzing the selected candidate segments.

Description

Test equipment with amplification function (2)

The present invention relates to a device for testing a biological sample, and more particularly to a test device having a magnification function or an analyte quantification function.

At present, the testing of liquid contents is usually commissioned to a professional testing agency, which uses expensive microscope equipment with a high magnification ratio to perform the test. Since the average person does not have a microscope device, the test activity cannot be performed by the average person.

However, in some of today's testing categories, periodic testing needs to be performed; therefore, for requirements that require frequent testing, it can be burdensome in terms of time and cost. For example, the category of long-term testing includes semen testing for infertile patients. The semen test is mainly performed on the number of sperm, their motility and morphology.

The semen test method includes: leaving semen of a male subject at room temperature for a period of time, obtaining a drop of the sample and instilling the sample on a glass slide, and observing the sample under a microscope. These observations include not only high-magnification observations performed on individual sperm to identify the external appearance of the individual sperm, but also a large number of total sperm, their motility, morphology, and number per unit area. However, individuals cannot perform semen tests themselves, as the industry has not yet developed technologies that allow individuals to perform tests via simple assistive devices.

The present invention provides a testing device with a magnifying function. The device includes: a receiving mechanism for receiving a carrier, wherein the carrier includes a holding area, wherein the holding area carries the biological sample or the biological sample has been exposed; A camera module configured to capture a collection of images of a holding area; and a processor configured to use the camera module to (1) retrieve from the captured area of the holding area A collective image identifying a visual cue on the carrier, and (2) performing a set of analysis processing procedures on the captured collective image based on a result of the recognition of the visual cue; wherein the group The analysis processing program includes: dividing the captured set image into a plurality of blocks; selecting a plurality of candidate blocks from the plurality of blocks for analysis, wherein the selection of the candidate blocks is based on the (1) block The degree of focus, and (2) the normality of the block, and one or more characteristics of the biological sample are determined by the plurality of candidate blocks (selected candidate blocks).

The amplification device of the present invention is cheaper, requires less labor for testing, and is easier to use than conventional test devices. The technique can be applied to semen testing as well as other testing areas, such as microbial-containing water, water quality, blood, urine, body fluids, stool and skin surface tissues / cells. The technology provides simple test products with significantly lower cost of use compared to prior art using laboratory microscope equipment.

Compared to the prior art, the test device with amplifying function disclosed herein provides a simple structure that can significantly reduce the cost of a sample enlargement test structure for tests such as sperm testing, urine analysis, or other body fluid analysis. The technology disclosed herein can be used in a wide range of applications by designing a carrier with sample holding areas, magnification components, and unique innovative settings. For example, a test device with an amplification function can be used to detect the count, motility, and morphology of sperm samples.

The test device with an amplification function of the present invention is suitable for performing a test at home. Test results are available immediately and at low cost. For example, a test device with a magnifying function provides a way to assess male fertility of a couple trying to conceive at home, so that the couple can make an informed decision on whether medical intervention is needed.

The disclosed technology can be easily integrated with existing smart communication devices such as smart phones or single board computers, and can use existing smart communication devices to capture enlarged test images and perform subsequent operations such as storing and transferring images. The low cost of such devices allows them to be implemented as disposable devices or reusable devices.

At least some specific examples of the present invention relate to a device (eg, a test box or a test strip) for testing a biological sample. The device includes a sample carrier and a removable cover. The sample carrier includes a sample holding area. A removable cover is placed on top of the sample holding area. The detachable housing includes a magnifying assembly configured to align with the sample holding area. The focal length of the magnifying element is 0.1 millimeter (mm) to 8.5 mm. The magnification component has a linear magnification ratio of at least 1.0.

At least some specific examples of the present invention relate to a system for testing a biological sample. The system includes the device and base assembly for testing a biological sample mentioned above. The base assembly includes an insertion port for inserting a device for testing a biological sample into the base assembly. The base assembly further includes a camera assembly for capturing an image of the sample holding area, or a form-fitting frame of a mobile device for fixing the camera component for capturing the image of the holding area of the sample. The base assembly may further include a supplementary lens disposed under the camera assembly. The combination of the magnifying element and the complementary lens may have an effective linear magnification ratio of at least 1.0.

At least some specific examples of the present invention relate to a method for testing sperm using a device for testing a biological sample. The method includes the steps of obtaining a device for testing the biological sample mentioned above, applying a sperm sample to a sample holding area, and recording a video or image of the sperm sample; based on the recorded video or recorded image Determine the sperm count of the sperm sample by at least one frame of the image; and determine the sperm motility of the sperm sample based on the recorded video or the recorded image.

At least some specific examples of the present invention relate to a system for testing a biological sample. The system includes a disposable device and a base assembly for testing a biological sample. The disposable device includes a sample carrier including a sample holding area and a detachable cover placed on top of the sample holding area. The base assembly includes an insertion port for inserting a disposable device into the base assembly and a camera. A camera including an image sensor and an optical lens module captures one or more images of a sample holding area.

Some specific examples of the invention include devices for testing biological samples. The device may include a housing having an opening. The receiving mechanism can receive the carrier inserted through the opening. The holding area of the carrier may include an adjacent first holding area and a second holding area. The first holding area and the second holding area may carry a biological sample or have been exposed to a biological sample.

In some implementations, the device may include two camera modules. The camera module is a first camera module configured to capture one or more images of the first holding area, and a second camera configured to capture one or more images of the second holding area. Module. In addition, some specific examples include a main circuit board carrying a processor configured to execute a first analysis processing program on a captured image of a first holding area. The processor may be configured to execute a second analysis processing program different from the first analysis processing program on the captured image of the second holding area. In some specific examples, the processor may determine a result regarding the biological sample based on the results of both the first analysis processing program and the second analysis processing program. According to one or more specific examples, the receiving mechanism, the first and second camera modules, and the main circuit board are all packaged in a casing.

Furthermore, in some specific examples, when the processor recognizes that the first holding region is in the first shape, the processor is configured to execute a certain analysis processing program. For example, if the first shape indicates that the biological sample includes sperm from a male subject, the processing program may determine one or more characteristics of the sperm. Determinable characteristics may include: the number of cells (eg, the number of sperm), the concentration of sperm, the motility of the sperm, and / or the shape of the sperm. In some examples, the determination of one or more characteristics of the sperm may be performed by using a second camera module. In some of these examples, the processor further determines at least one additional characteristic of the sperm by using the first camera module. This additional characteristic may include the acidity of the sperm. For example, the carrier may include a pH indicator indicating the acidity of the sperm in a color in the first holding area, and the processor may identify the color used to identify the acidity.

In some examples, when the processor recognizes that the first holding area is in a second shape that may indicate that the biological sample includes urine from a female subject, the processor is configured to determine one or more of the urine characteristic. Determinable characteristics may include: luteinizing hormone (LH) levels, follicle stimulating hormone (FSH) levels, and / or human chorionic gonadotropin (HCG) levels. As with acidity, determination of one or more characteristics of urine can be performed by using a first camera module. Similarly, the carrier may include an LH indicator, an FSH indicator, and / or an HCG indicator in the first holding area.

In some specific examples, the first camera module has a lower magnification ratio and / or a lower camera resolution than the second camera module.

In some specific examples, the processor may be configured to (1) identify the shape of the first holding area on the carrier using the first camera module; and (2) select a group to be performed based on the shape of the first holding area. Analysis handler. The shape of the first holding area can identify the gender information of the biological sample. Then, in response to the shape of the first holding region being the first shape, the set of analysis processing programs selected by the processor can determine the fertility of the germ cells of the first sex. In addition, in response to the shape of the first holding area being the second shape, the set of analysis processing programs selected by the processor can determine the fertility of the germ cells of the second sex.

The invention further provides a device for testing a biological sample, the device comprising:
A housing, the housing including an opening; a receiving mechanism for receiving a carrier, the receiving mechanism receiving the inserted carrier through the opening; wherein the carrier includes a holding area, wherein the holding area carries The biological sample or the biological sample has been exposed; a camera module configured to capture one or more collective images of a holding area; and a circuit board carrying a processor, the processor is configured A camera module is used to (1) identify a visual cue in or near the holding region on the carrier from the captured image of the holding region, and (2) based on the visual cue A result of the identification, selectively performing a set of analysis processing procedures on the captured images of the holding area; wherein the processor is further configured to, after the analysis processing procedures are executed, based on The result of the analysis processing program determines a final result regarding the biological sample; wherein the receiving mechanism, the camera module, and the circuit board are packaged in the casing.

Preferably, in the above device, the visual cue is a size that is not perceived by humans, and the size is recognized by the camera module after being enlarged through a micro lens.

Preferably, in the above device, an appearance dimension of the casing is less than 27000 cm3.

Preferably, the device further includes: a second camera module, wherein the processor is further configured to use the second camera module to identify a shape of a second holding area on the carrier.

The present invention further provides a method for determining the characteristics of a biological sample, comprising: using the device as described above, operating a processor to use a camera module to (1) identify the captured set image from the holding area in the holding area; A visual cue on the carrier, and (2) based on a result of the visual cue and the identification, selectively performing a set of analysis processing procedures on the captured set images; wherein the set of analysis processing procedures includes: Dividing the retrieved set image into a plurality of blocks; selecting a plurality of candidate blocks for analysis from the plurality of blocks, wherein the selection of the candidate blocks is based on the degree of focus of the block (1), and ( 2) The normality of the block, and one or more characteristics of the biological sample are determined by the plurality of selected candidate blocks.

Reference will now be made in detail to the presently preferred specific examples of the present invention, examples of which are illustrated in the accompanying drawings.

FIG. 1A and FIG. 1B illustrate a test device with an amplification function according to a specific example of the present invention. The specific examples disclosed herein are for illustrative purposes and should not be considered as a required limitation of the present invention. The test device A1 with a magnifying function includes at least one of a carrier 10 having a sample holding area 11 formed on the top of the carrier 10, a cover 20 stacked on the top of the carrier 10, and a convex lens-type surface formed on the cover 20. The magnifying part 30 (also referred to as a magnifying component or a magnifying glass).

The magnifying member 30 of this specific example includes a plano-convex lens as shown in FIG. 1A. However, other types of magnifying lenses (for example, double-sided lenticular lenses) may be included as the magnifying member 30. The magnifying member 30 is arranged to align with the sample holding region 11 of the carrier 10 and cover the sample holding region 11. The magnifying component 30 may have various magnification ratios based on the test requirements of various tests. For example, the test may include a semen test, a urine test, a synovial fluid test, a skin test, a water test, or other body fluid test, and the like.

The test using the magnifying function test device A1 of this specific example does not require an expensive and time-consuming additional magnifying lens or laboratory microscope. In addition, there is no need to align the sample holding area with the magnifying lens or laboratory microscope.

As shown in FIG. 1A, the sample holding region 11 of the carrier 10 may be formed to have a recessed structure. The recessed structure design provides a stable and large storage space containing the sample 40. The recessed structure allows the sample to rest for a required period of time before performing the test. For example, before performing a motility test on a semen sample, it is necessary to allow the semen sample to stand at room temperature for a required period of time before performing a motility test.

The sample 40 may be first dripped into the recessed structure (ie, the sample holding area 11 of the carrier 10) to stand for a period of time. As shown in FIG. 1B, the total area of the outer cover 20 may be smaller than the total area of the carrier 10. A sample receiving port 12 exposed outside the cover 20 is formed on one side of the sample holding area 11. The sample receiving port 12 may be designed to have an outwardly expanding shape, which may help to smoothly inject a sample.

FIG. 2A shows an air channel 13 extending beyond the other side of the housing 20 and formed on the other side of the sample holding area 11. The air channel 13 prevents air from filling the inside of the sample holding area 11, and the filling prevents the sample from being received when the sample is in a liquid state.

As shown in FIG. 2A, the side lighting device 50 may be disposed at one side of the carrier 10 of the test device A1. The lateral illumination device 50 can provide illumination for the sample 40 in the sample holding area 11 and thus improve the resolution of the captured test image of the sample 40. In some specific examples, the sample holding area 11 may receive illumination from a light source on the top or bottom of the test device A1.

As shown in FIG. 1A, the magnifying member 30 and the cover 20 may be integrally formed, that is, the magnifying member 30 and the cover 20 may be a single component. In other specific examples (such as the specific example shown in FIG. 2B), the detachable cover 20 and the upwardly facing concave member disposed on the detachable cover 20, that is, the magnifying member 30 in the groove 21 may each be suitable for integration Independent components together. In other words, the same type of detachable cover 20 can be integrated with different magnification parts 30 of various magnification ratios.

In some specific examples, the distance between the bottom of the removable cover 20 and the sample holding area 11 is 0.005 mm to 10 mm. In some specific examples, the distance between the bottom of the removable cover 20 and the sample holding area 11 is about 0.01 mm. The test device may include one or more spacers (not shown) to ensure the distance between the bottom of the removable cover 20 and the sample holding area 11. The spacer may be formed integrally with the sample holding area 11 of the detachable cover 20 or the carrier 10.

In some specific examples, a strip including the carrier 10 and the cover 20 is used for sperm testing. In some specific examples, the optimal angular magnification ratio used to determine sperm concentration and motility is about 100 to 200. In some specific examples, the optimal angular magnification ratio used to determine sperm morphology is about 200 to 300. The thinner the magnifying component, the higher the angle magnification ratio.

The focal length of the magnifying component can also be related to the angle magnification ratio. In some specific examples, a magnifying component having an angular magnification ratio of 100 has a focal length of 2.19 mm. The magnifying element having an angular magnification ratio of 156 has a focal length of 1.61 mm. The magnifying element having an angular magnification ratio of 300 has a focal length of 0.73 mm. In some specific examples, the magnification component has an angular magnification ratio of at least 30, preferably at least 50. In some specific examples, the focal length of the magnifying component is 0.1 mm to 3 mm.

FIG. 3 shows a sample processing program for performing a test using the test device A1 with a zoom-in function shown in FIG. 1B. In step S110, the sample 40 to be tested is set in the sample holding area 11. In step S110, the cover 20 is stacked on the top of the carrier 10, and then the sample 40 to be tested is set in the sample holding area 11 from the sample receiving port 12. Alternatively, the sample 40 to be tested may be directly set in the sample holding area 11 first, and then the cover 20 is stacked on the top of the carrier 10. In step S120, according to the test requirements of the sample 40, the sample 40 is placed in the sample holding area 11 for a period of time selectively. In step S130, a smart communication device (for example, a mobile phone) is attached to the housing 20, and the camera of the mobile phone is aligned with the magnifying part 30 to use the camera of the mobile phone to capture an image of the sample through the magnifying part 30 Or video. In step S140, an application program (APP) running on a mobile phone or other analysis device can be used to perform analysis on the image or video to obtain a test result.

As shown in FIG. 4, a supporting side such as the protruding member 14 may be further formed at the boundary of the magnifying member 30 on the top of the cover 20 of the test device A2. In some specific examples, the protruding-type support structure may be formed on the top of the outer cover 20 by adding a protruding member 14. When a user attempts to capture an image or video of a sample using a smart communication device 60 (for example, a mobile device such as a smart phone or a single-board computer), one side of the smart communication device 60 having the camera 61 may be fixed to the protruding member 14 (in the direction shown by arrow L1). Therefore, the test device A2 allows the user to use the smart communication device 60 to capture images or videos of the sample, and does not require expensive test devices to record images or videos. In addition, for an optimal observation distance, the height of the protruding member 14 may be predetermined based on the specifications of the camera 61 and the test device A2.

As shown in FIGS. 5 and 6, the test device A3 may include a meter device 70 (also referred to as a base assembly). The meter device 70 includes a lower barrel base 71 and an upper barrel body 72 that can be raised or lowered relative to the lower barrel base 71. The lower barrel base 71 has an insertion port 73 that provides an insertion position for the outer cover 20 and the carrier 10 stacked together. The upward light emitting device (also referred to as a light source) 80 is disposed on the bottom of the lower barrel base 71 to provide illumination from the bottom to the combination of the cover 20 and the carrier 10. The upper barrel body 72 may include, for example, at least one additional magnification lens 74 for further magnification.

The upper barrel main body 72 may be attached to the lower barrel base 71 using a screw mechanism so that the upper barrel main body 72 can be raised or lowered relative to the lower barrel main body 71 like a screw. In other words, the upper barrel main body 72 is rotatable relative to the lower barrel base 71 in the direction of the arrow L2 so that the upper barrel main body 72 moves upward and downward relative to the lower barrel base 71 in the direction of the arrow L3. By adjusting the height of the upper barrel main body 72 relative to the lower barrel main body 71, the system adjusts the height of the magnifying lens 74 (changes the magnification ratio) and the height of the camera 61.

An assembling frame 75 (also referred to as a form-fitting frame) may be disposed at an upper end of the upper barrel main body 72. The assembling frame 75 fixes the smart communication device 60 at a predetermined position. The assembling frame 75 has a camera alignment hole 76. The camera 61 of the smart communication device 60 can receive light from the sample through the camera alignment hole 76.

The camera 61 mounted on the current smart communication device 60 typically has only a digital zoom function. In general, high-accuracy testing requires an optical zoom lens. However, the user using the test device A3 does not need a camera 61 having an optical zoom lens. The height adjustment function of the test device A3 provides a flexible solution for aligning the sample, the magnifying lens and the camera 61.

FIG. 6 shows the smart communication device 60 assembled and fixed to an assembly frame 75 which is disposed on the upper barrel main body 72. The cover 20 and the carrier 10 containing the sample 40 are inserted through the insertion port 73. The upward-facing light emitting device 80 can provide illumination to the sample and increase the brightness of the sample.

FIG. 6 shows the smart communication device 60 assembled and fixed to an assembly frame 75 which is disposed on the upper barrel main body 72. The cover 20 and the carrier 10 containing the sample 40 are inserted through the insertion port 73. The upward-facing light emitting device 80 can provide illumination to the sample and increase the brightness of the sample.

The upper barrel main body 72 or the meter device 70 can be rotated in the direction L2 to adjust the height of the magnifying lens 74 and the camera 61 upward or downward in the direction L3. The height adjustment mechanism realizes the function of adjusting the magnification ratio. The camera 61 can capture a dynamic video or a static test image of the sample 40 after zooming in. In addition, the smart communication device 60 may use its original equipment function to store captured video or images, transfer test images or videos, and perform subsequent processing.

As shown in FIG. 7, the test device A4 having an enlargement function includes a plurality of enlargement members 30, 30B, and 30C having different enlargement ratios disposed on the cover 20. The user can offset the cover 20 to align the sample holding area 11 of the carrier 10 with any one of the magnifying members 30, 30B, 30C having different magnification ratios in order to obtain test results with different magnification ratios. With this design, the test device A4 with a single module amplification function can be applied to meet the amplification requirements of multiple test protocols without the need to change the amplification components or covers.

As shown in FIG. 8, the test device A5 having a magnifying function includes a flexible transparent film 15. The flexible transparent film 15 is disposed between the carrier 10 and the magnifying member 30 and covers the sample holding region 11. The flexible transparent film 15 covers the sample 40 (in a liquid state) so that the sample 40 is in a restricted space. Therefore, external influences caused by air, dust and dirt are restrained to a minimum. In addition, the test device A5 can adjust the focal length by changing the thickness of the flexible transparent film 15.

As shown in FIG. 9, the magnifying member 30 of the test device A6 having a magnifying function is a flat convex lens, and the surface of the magnifying member 30 facing the carrier 10 is a protruding surface. Therefore, an upwardly concave hollow member, that is, a groove 21 is formed at the surface of the magnifying member 30 facing the carrier 10. The focal length parameter H1 is defined by the thickness of the thickest part of the magnifying member 30 of the plano-convex lens. As shown in FIG. 10, the focal length parameter H2 of the test device A7 with a magnification function is different from the focal length parameter H1 of FIG. 9.

The focal lengths H1 and H2 can be adjusted by changing the thickness of the cover 20 or the curvature of the magnifying member 30. For example, the focal length H2 shown in FIG. 10 is greater than the focal length H1 shown in FIG. 9, and is achieved by changing the magnitude of the curvature of the magnifying member 30. In this way, the test requirements for various focal lengths can be met by using different magnifying components 30.

In some specific examples, the magnifying member 30 may be transparent and the rest of the cover 20 may be opaque. In addition, the carrier 10 may include a transparent sample holding region 11. The remainder of the carrier 10 may be opaque. When a test operation is performed on a test device, light can propagate through the sample holding area 11 and the magnifying part 30 to suppress the chance of light interference in other parts of the device.

Referring to FIG. 11, in the test device A8 having a magnifying function, the carrier 10 of the test device A8 further includes a beam assisting guide structure 16 formed at a bottom surface of the carrier 10. The carrier 10 may be made of a transparent or translucent material. The beam-assisted guiding structure 16 may be opaque or include a particle structure, a rough pattern, an engraved pattern, or other suitable structure that scatters the light beam reaching the guiding structure 16. The beam-assisted guiding structure 16 may provide a specific pattern for the entire surface or a part of the surface of the cover and the carrier. The light beam auxiliary guiding structure 16 can also be formed all around the side surface of the carrier 10.

When the housing 20 and the carrier 10 are stacked and attached to the smart communication device 60 (for example, as shown in FIG. 4), the magnifying member 30 is aligned with the camera 61 of the smart communication device 60. In addition, supplementary light (not shown) may be placed near the camera 61 on the surface of the smart communication device 60. The light beam provided by the supplementary light can be directed to the carrier 10 to illuminate the sample holding area 11 through the cover 20. At the same time, the beam-assisted guiding structure 16 of the carrier 10 can scatter the beam provided by the supplemental light, thereby improving the brightness and uniformity of illumination of the sample holding region 11.

By arranging the beam-assisted guiding structure 16, the test device does not require an additional supplementary light source to illuminate the carrier 10. Therefore, the cover 20 includes a light transmissive material so that supplementary light of the smart communication device 60 can pass through the cover 20 to the sample. In some alternative specific examples, the device does not include the cover 20 and the supplemental light directly reaches the carrier 10 without propagating through the cover 20.

The test device A8 with a magnifying function may include a non-slip film 92, a release paper 96, and a pH test paper 94. A non-slip film 92 is attached on a supporting side (such as the top side) of the cover 20 and is used to stably place the cover 20 to the camera 61 of the smart communication device 60, as shown in FIG. 4, so that the magnifying member 30 communicates with the smart The camera 61 of the device 60 is aligned. Using the non-slip film 92, the positioning of the smart communication device 60 relative to the test device A8 is fixed to a predetermined structure.

The non-slip film 92 may have an opening aligned with the magnifying member 30 so that the non-slip film 92 does not block light transmitted from the sample to the camera 61 through the magnifying member 30. The non-slip film 92 may include, for example, a silicon material, and the surface of the non-slip film 92 may be protected by using the release paper 96 to maintain paper adhesion. The pH test paper 94 can be placed on the sample holding area 11 of the carrier 10 to provide an indication of the pH value of the sample. The pH test paper 94 can be replaced after use.

In addition, the amplifying member 30 and the cover 20 may be detachable. Therefore, the user can select another enlargement part 31 different from the enlargement part 30 to replace the original enlargement part 30 based on the test requirements. Various magnifying components that can be assembled with the housing 20 are assembled to achieve different magnification ratios or other optical characteristics.

Referring now to FIG. 12, the test device A9 with a magnification function may further include a sample collection sheet 42 disposed in the sample holding area 11. The sample collection sheet 42 has, for example, a sample collection area 42A. The sample collection area 42A can be used to collect sperm, subcutaneous tissue / cells, parasite eggs, and similar solid test subjects using adhesion or other methods. In some specific examples, the sample collection sheet 42 can be used as a spacer to maintain the distance between the cover 20 and the sample holding area 11.

Next, referring to FIG. 13, the test device A10 with an amplification function may include an isolation assembly 98 disposed at the sample holding area 11 between the carrier 10 and the cover 20. The isolation component 98 can isolate the amplifying component 30 from the test liquid in the sample holding area 11 and prevent the test liquid from contaminating the amplifying component 30. In some specific examples, the isolation assembly 98 can be used as a spacer to maintain the distance between the outer cover 20 and the sample holding area 11. The isolation assembly 98 may be integrated with the housing 20 as a single assembly. Alternatively, the isolation component 98 may be integrated with the carrier 10 as a single component.

14A is a schematic diagram of a test strip inserted into a meter device according to another embodiment of the present invention. The test strip 5 (also referred to as a test box) includes a removable cover 20 and a carrier 10. In other words, the combination of the detachable cover 20 and the carrier 10 (for example, as shown in FIG. 1B) forms a test strip 5. The test strip 5 is inserted into the meter device 70 (also referred to as a base assembly) through the insertion port. The insertion port may be, for example, a lateral or vertical insertion port. The meter device 70 may include, for example, a component for capturing an image of a sample collected in the test strip 5.

FIG. 14B is a schematic diagram of components of a meter device according to another embodiment of the present invention. The meter device 70 includes an insertion port 73 that provides an insertion position of the test strip 5. The test strip 5 includes a carrier 10 and a removable cover 20. The detachable cover includes an amplifying part 30. The meter device 70 includes a camera 61 for capturing an image or video of a sample holding area of the carrier 10. The camera 61 is aligned with the magnifying member 30. The meter device further includes a light source 80 for providing illumination of the sample holding area from the bottom. In some specific examples, a collimator (eg, a collimator lens or a light reflector; now shown) may be placed on top of the light source 80 for collimating the light beam. The ring-shaped diaphragm can be further placed between the light source 80 and the collimator so that the light beam traveling through the collimator can form a hollow cone-shaped beam. The carrier 10 may include a transparent or translucent material for light transmission.

In some specific examples, the meter device 70 may further include a phase plate that shifts the phase of the light emitted from the sample holding area. As light travels through the sample, the speed of the light increases or decreases. Therefore, the light that propagates through the sample is out of phase (about 90 degrees) with the remaining light that does not propagate through the sample. Out-of-phase light interferes with each other and enhances the contrast between the bright and dark portions of the sample image.

The phase plate can further shift the phase of the light propagating through the sample by about 90 degrees in order to further enhance the contrast caused by the interference of out-of-phase light. Therefore, the light propagating through the sample is about 180 degrees out of phase with the remaining light that is not propagating through the sample. This destructive interference between the lights enhances the contrast of the sample image by darkening the objects in the image and brightening the boundaries of the objects.

In some alternative embodiments, this phase plate can be placed on top of the removable cover 20 of the test strip 5. In other words, the phase plate may be part of the test strip 5 instead of part of the meter device 70.

FIG. 15 shows a sample processing procedure for a semen test by a device such as the meter device 70 or the smart communication device 60 shown in FIGS. 5 and 14, respectively. In step 1505, the device obtains an image (frame) of the sample. In step 1510, the device determines the sperm concentration based on the image. In step 1515, by analyzing the color or grayscale of the pH band, the device can further determine the pH value of the sample. For example, the device may include processing to identify the color of a portion of the image captured by the camera (corresponding to the pH band) and determine the biochemical characteristics (e.g., pH level) of the biological sample contained in the band Device. In some other specific examples, the light source of the device can provide illumination with at least one color. For example, the light source may include light emitters having different colors (eg, red, green, and blue) to form various colors of light. The device's camera can further capture at least one (or more) images of the sample illuminated with light. The processor may compare the color of a specific region of the image (eg, a pH band region) to determine the characteristics of the biological sample or the quantification of the analyte. In some specific examples, the processor only needs the color of a specific area of an image to determine the characteristics of the biological sample. For example, a device (eg, a test device) may include a color correction module for correcting the color of an image. The processor then analyzes the corrected image to determine the characteristics of the biological sample. Alternatively, the test strip may include a color correction area with a known color. The processor performs a color correction operation on the image based on the color correction region, and then analyzes the corrected image to determine the characteristics of the biological sample or the quantification of the analyte. In some specific examples, a reagent in a pH band (or other type of biochemical test strip) reacts with a biological sample, and then a specific area of the image (eg, a pH band area) shows a specific color. In some specific examples, the specific area used for color detection must necessarily enlarge the image captured by the camera. Therefore, at least in some specific examples, there are no magnifying components or supplements above a specific area of the band used for color detection (eg, the pH band area). For example, some types of biochemical test strips contain photochemical reagents. When a photochemical reagent reacts with a specific analyte in a biological sample, the reaction causes a color change in the sample holding area of the band. The processor can analyze the image of the test strip (captured by the camera) to detect color changes and quantify specific analytes in the biological sample. In addition, the device can determine sperm morphology (1520), sperm volume (1525), and total sperm (1530). In step 1540, the device obtains a series of multiple frames for one of the samples. In steps 1545, 1550, and 1555, the device may determine sperm motility parameters and determine sperm motility based on the sperm trajectory. FIG. 16 shows a sample processing program for determining sperm concentration. In 1605, an enlarged image of a sperm sample is taken by a camera of the meter device 70 or the smart communication device 60 ("the device") shown in Figures 5 and 14, respectively. The captured image is the original image used to determine the sperm concentration. The device then converts the digital color image into a digital grayscale image, and further divides the digital grayscale image into a plurality of regions.

In step 1610, the device performs an adaptive fixed-binary binary calculation on each region based on the average value and the standard deviation of the gray value of each region. The goal of the adaptive finite-binary calculation is to identify an object that is a candidate for sperm as a foreground object, and to identify the rest of the region as a background.

The foreground object in the image after the binary calculation may still include impurities that are not actually sperm. Their impurities are smaller or larger than the sperm. The method may set an upper boundary value and a lower boundary value for the size of the sperm. In step 1615, the device performs a noise reduction operation on the image by removing impurities that are larger than the boundary value above the sperm or smaller than the boundary value below the sperm. After the noise reduction operation, the foreground object in the image represents sperm.

The method counts the number of sperm in an image based on the head portion of the sperm. In steps 1620 and 1625, the device performs a distance transform operation to calculate the minimum distance between the foreground object and the background, and also recognizes the location of the local maximum. These positions are candidates for the position of the sperm head.

In step 1630, the device performs an ellipse fitting operation on each sperm candidate to reduce false positive candidates that do not have an elliptical shape and are therefore not the sperm head. The device then counts the total number of remaining positive candidates for sperm, and calculates the concentration of the sperm based on the volume represented by the image. The volume can be, for example, the area of the sample holding area multiplied by the distance between the sample holding area and the bottom of the housing.

In some specific examples, the device may use multiple images of a sample and calculate a concentration value based on the images, respectively. Then, the device calculates the average of the concentration values to minimize the measurement error of the sperm concentration.

Using a series of images from a sample (eg, a video frame), the device can further determine the trajectory and motility of the sperm. For example, FIG. 17 shows sample sperm such as sperm 1705 and sample sperm trajectories such as trajectory 1710 and trajectory 1720.

FIG. 18 shows a sample processing program for determining sperm trajectory and motility. A series of images (e.g., video frames) of sperm samples are captured by the cameras of the meter device 70 or the smart communication device 60 ("the device") shown in Figs. 5 and 14, respectively. The device uses a series of captured images to determine the parameters of sperm motility. To determine the parameters of sperm motility, the device needs to track the trajectory of each sperm in the series of images.

The device converts a digital color image into a digital grayscale image. The device first identifies the head position of the sperm in the first image of the series (for example, using the method shown in FIG. 16). The identified head position of the sperm in the first image is the initial position of the sperm trajectory to be tracked. In some specific examples, the device may use a two-dimensional Kalman filter to estimate the trajectory of the sperm movement.

In some specific examples, it is used to track Sperm The two-dimensional Kalman filtering includes the following steps:
1: Calculate prediction status Covariance matrix :


2: Use prediction status Measured value Covariance matrix To calculate the predicted measurement Measured value residuals Covariance matrix :

3: if and , Then calculate the Kalman filtering gain Updated status estimates And updated error covariate matrix :

Represents the prediction of image k based on image k- 1, The position and velocity of the j-th sperm. Is the covariate matrix of the estimated error, Q (k- 1) is the covariate matrix for processing noise, N (k ) is the covariate matrix of the white position noise vector, γ is the gate threshold For maximum possible sperm speed.

When tracking multiple trajectories of multiple sperm, the method may use joint probability data association filtering to determine the trajectory path. The joint probability data association filtering determines a feasible joint association event between a detection target and a measurement target. Feasible Joint Correlation Event ( ) Is the relative probability value between detecting sperm s and measuring sperm j . Then, the method makes a path allocation decision based on the best designation method. A _{js is} defined as:

λ is the parameter, Gaussian probability density function for detecting sperm.

Based on the series of frames over a period of time, the method identifies the trajectory of each sperm, such as the trajectory 1805 as shown in FIG. 18. The method then determines various parameters of sperm motility based on the trajectories. These parameters include, for example, curvilinear velocity (VCL), straight-line velocity (VSL), linearity (LIN), and amplitude of lateral head displacement (ALH). Curve speed (VCL) 1810 is defined as the sum of the distance traveled in a unit time. Linear speed (VSL) 1815 is defined as the linear movement distance in unit time. Linearity (LIN) is defined as VSL divided by VCL. The lateral head displacement magnitude (ALH) 1820 is defined as twice the magnitude of the lateral displacement of the sperm head relative to the average path 1825.

In some specific examples, Curve Velocity (VCL) 1810 can be used to determine sperm motility. The method can set a speed threshold. Any sperm with a VCL above or equal to the speed threshold is identified as an active sperm. The remaining spermatozoa with VCL below the speed threshold were identified as inactive spermatozoa. The level of motility is the number of active sperm identified divided by the total number of sperm identified from the image.

The method can further analyze sperm morphology. A camera of the meter device 70 or the smart communication device 60 (the "device") captures an enlarged image of a sperm sample. The captured image is the original image to determine the sperm morphology.

The method is based on detecting the shape of sperm candidates in segments. The method uses the position of the head of these sperm as an initial point. Using a shape-dependent segmentation algorithm, the method segments an image of a sperm into a head portion, a neck portion, and a tail portion. For example, the method may segment the sperm using a method such as an active contour model.

Based on the parts, the method calculates parameters (such as length and width) of the various parts. A classifier (such as a support vector machine, neural network, convolutional neural network, or AdaBoost algorithm) can be trained using a training data set that includes labeled samples. After training, the parameters of various parts of the sperm can be fed to the classifier to determine whether the sperm has the proper morphology. In some specific examples, the classifier can be used in other applications such as detecting the characteristics of cells and microorganisms.

FIG. 19 is a schematic diagram of a testing device including a collection bottle according to at least one specific example of the present invention. The test strip device 1905 can be inserted into the test device 1900 through an insertion port. The test strip device 1905 may include a collection bottle 1910 for collecting a sample (eg, a sperm sample) or a slot for receiving the collection bottle. The test device 1900 may include a sensor (not shown) to detect whether the collection bottle 1910 is inserted into the test device 1900.

The test device 1900 may have a timer mechanism for determining the period of time that the collection bottle 1910 has been inserted into the test device 1900. After inserting the collection bottle 1910 containing the sample, the test device 1900 may wait for a predetermined period of time (eg, 30 minutes) to liquefy the sample, and then prompt the user to transfer the sample from the collection bottle 1910 to the test strip device 1905. In some specific examples, the test device 1900 may include a camera or sensor to determine whether a sample has been liquefied.

In addition, the testing device may include a moving mechanism to apply a mechanical force to the collection bottle 1910 to mix the sample in the collection bottle 1910. For example, the moving mechanism may, for example, shake, vibrate, or rotate the collection bottle 1910. In some other specific examples, the test device may include a rod to be inserted into the collection bottle 1910 and agitate the sample in the collection bottle 1910.

The test device 1900 may optionally include a display (eg, a screen 1920) for displaying information. For example, the screen 1920 may show instructions or tips on how to operate the test device 1900. The screen 1920 may also show test results after the test by the test device 1900. Additionally or alternatively, the test device 1900 may include a known communication module so that it can communicate with a user's computing device (eg, a smartphone with a mobile software application, or a traditional personal computer such as a laptop computer) ( (Eg, analysis results and / or images acquired by a camera module). The test device 1900 is operable to receive instructions from a user (eg, from the screen 1920 and / or from the aforementioned communication module), and execute a selected number of automated analysis processes based on the instructions. The test device 1900 may also display the results and / or images of the samples on the screen 1920 or the user's computer (eg, via the aforementioned communication module), or both.

Similar to the test device shown in FIGS. 14A and 14B, the test device 1900 may include a camera (not shown) for capturing an image or video of the test strip device 1905. The test device 1900 may further include a processor (not shown) for processing an image or a video (eg, via a processing program shown in FIG. 16) for determining a test result.

In some specific examples, for example, the magnifying component 2110 is a magnifying lens. The magnification capability of the magnification component 2110 can be expressed by an angle magnification ratio or a linear magnification ratio. The angular magnification ratio is the ratio between the angular size of the object as seen through the optical system and the angular size of the object as seen directly at the nearest clear vision distance (ie, 250 mm from the human eye). The linear magnification ratio is a ratio between the size of an image of an object to be projected on an image sensor and the size of an actual object.

For example, the magnifying lens may have a focal length of 6 mm, a thickness of 1 mm, and a diameter of 2 mm. Assuming that 250 mm is the near point distance of the human eye (ie, the closest distance that the human eye can focus on), the angular magnification ratio is 250 mm / 6 mm = 41.7 times. The distance between the magnifying component 2110 and the sample holding area 2115 may be, for example, 9 mm. Therefore, the linear magnification ratio can approach 2. In other words, the size of the image of the object on the image sensor caused by the magnification component is twice the size of the actual object below the magnification component.

In some specific examples, the magnification component has a focal length of 0.1 mm to 8.5 mm. In some specific examples, the linear magnification ratio of the magnification component is at least one. In some specific examples, the linear magnification ratio of the magnification component is 0.5 to 10.0.

In some specific examples, the supplemental lens 2135 is disposed below the camera module 2130 to further enlarge the image and reduce the distance between the magnification component 2110 and the sample holding area 2115. The effective linear magnification ratio of the entire optical system may be, for example, 3. In other words, the size of the image of the object captured by the camera module 2130 is three times the size of the actual object in the sample holding area 2115. In some specific examples, the effective linear magnification ratio of the entire optical system of the test device is 1.0 to 100.0, preferably 1.0 to 48.0.

In some specific examples, the image sensor of the camera module has a pixel size of 1.4 μm. Typically, a captured image of an object needs to acquire at least 1 pixel in order to properly analyze the shape of the object. Therefore, the size of the captured image of the object needs to be at least 1.4 μm. If the linear magnification ratio of the test device is 3, the test device can properly analyze the shape of an object having a size of at least 0.47 μm.

In some specific examples, the image sensor of the camera module has a pixel size of 1.67 μm. Next, the size of the captured image of the object needs to be at least 1.67 μm in order to properly analyze the shape of the object. If the linear magnification ratio of the test device is 3, the test device can properly analyze the shape of an object having a size of at least 0.56 μm.

In some specific examples, the length of the entire optical system may be, for example, 24 mm, for example. The distance between the bottom of the magnifying assembly and the top of the sample holding area 2115 may be, for example, 1 mm. In some specific examples, the length of the entire optical system of the test device is 2 mm to 100 mm, preferably 5 mm to 35 mm.

FIG. 20 is a schematic diagram of a test device excluding a collection bottle according to at least one specific example of the present invention. Unlike the test device 1900, the test device 2000 does not include a collection bottle or a slot for inserting the collection bottle. The sample is applied directly to the test strip device 2005 by the user or operator without being collected in a collection bottle.

21B is a schematic cross-sectional view taken along the line A-A of a specific example of the test device 1900 of FIG. 21A. A-A cross section of the test device 1900 shows a camera module 2130 on the top of the test strip device 2105 for capturing an image or video of a sample holding area 2115 of the test strip device 2105. The test strip device 2105 includes a magnifying assembly 2110 on top of the sample holding area 2115. A light source 2140 below the test strip device 2105 provides illumination for the sample holding area 2115. In some other specific examples, the light source can be placed on top of the test strip device or placed laterally on one side of the test strip device. There may be multiple light sources or light source arrays for providing illumination on the test strip device. In some specific examples, different combinations of light sources may be switched, adjusted, or selected depending on the type of analyte, so that the analyte is illuminated by light with a proper color.

In some specific examples, the test strip device 2105 may include a test strip in or near the sample holding area 2115. For example, the test strip may be a pH test strip, a HCG (human chorionic gonadotropin) test strip, an LH (luteinizing hormone) test strip, or a fructose test strip. When an analyte of a sample in a sample holding area interacts with a chemical or biochemical reagent in a test strip, some optical characteristics (eg, color or light intensity) of the test strip may change. The camera module 2130 can capture the color or intensity of the test strip to determine the test result, such as the pH level, HCG level, LH level, or fructose level. In some specific examples, the magnifying assembly 2110 above the test strip may be replaced with a transparent or translucent cover. Therefore, the test device can simultaneously check the analyte in the sample and perform another analysis on the sample through one or more enlarged images of the sample.

21C is a schematic cross-sectional view taken along the line A-A of another specific example of the testing device 1900 of FIG. 21A. AA cross section of the test device 1900 shows a camera module 2130 on the top of the test strip device 2105 for capturing an image or video of a sample holding area 2115 of the test strip device 2105, which includes a sensor and a Or multiple lenses 2135 (also referred to as supplementary lenses or optical lens modules). A light source 2140 below (or placed elsewhere) the test strip device 2105 provides illumination for the sample holding area 2115. The magnifying assembly 2110 may be attached to the bottom of the lens 2135 instead of on the top of the sample holding area 2115 as shown in FIG. 21A. In some specific examples, if the lens 2135 provides sufficient magnification, the element 2110 may be a flat light transmissive cover without magnification. In some other specific examples, if the lens 2135 provides sufficient magnification capability (for example, if the linear magnification ratio of the lens 2135 is at least 1.0), the test device 1900 does not include a magnification component 2110.

FIG. 22 is a schematic diagram of a test device of a test strip device having two sample holding regions. FIG. 29 shows an example of a carrier that can be adapted to a test device having a multi-camera configuration, such as the test device shown in FIG. 22. Referring to both FIG. 19 and FIG. 20, the test device shown in FIG. 22 may be another variation of the test device 1900 (ie, with a collection bottle) or the test device 2000 (ie, without a collection bottle). As shown in FIG. 22, a receiving mechanism is included in the test device to receive one or more carriers (e.g., a test strip device such as a test strip device 2205, or a collection bottle such as a bottle 1910), the carrier may be via The opening in the housing of the test device is inserted.

In some specific examples, a single carrier may include a first holding region and a second holding region, such as shown by the test strip device 2205 in FIG. 22. As shown in FIG. 22, at least two camera modules may be included in a test device. The two camera modules include a first camera module 2230A and a second camera module 2230B configured to capture images and / or videos of the first holding area 2215A and the second holding area 2215B, respectively. More specifically, the test strip device 2205 may include a sample holding region 2215A and another sample holding region 2215B. In some examples, a transparent or translucent cover 2210A is placed on top of the sample holding area 2215A. The light source 2240A may be controllable and may provide illumination on the sample holding area 2215A. The first camera module 2230A is positioned to capture an image or video of the sample holding area 2215A. As an optional implementation, the magnifying component 2210B can be placed on top of the sample holding area 2215B. In addition, in some specific examples, the light source 2240B is operable to provide illumination on the sample holding area 2215B. The second camera module 2230B is positioned to capture an image or video of the sample holding area 2215B. The first holding area and the second holding area may directly carry a biological sample or have been exposed to a biological sample. Similar to the structure introduced with respect to FIG. 14B, in some specific examples, the test device may include a parallel light tube for collimating the light beam emitted by the light source to at least one of the holding areas. In some specific examples, the ring-shaped aperture may further include a hollow cone-shaped beam between the light source and the collimator for forming a hollow cone-shaped beam traveling through the collimator and then reaching the sample holding area. In some additional specific examples, the phase plate may include between the sample holding area and at least one of the camera modules for phase shifting light reflected by the sample holding area.

As an alternative to a single carrier with multiple holding areas, multiple carriers can be inserted into the test device via their individual openings, ports or slots. For example, two independent test strip devices may include sample holding areas 2215A and 2215B, respectively. Depending on the needs of the test, the positions of the sample holding areas 2215A and 2215B in the test strip may be designed to align with the first camera module 2230A and the second camera module 2230B. In some specific examples, two test strip devices are inserted into the test device via two independent insertion ports.

The convenience and ease of testing, among other benefits, are two significant benefits that the test devices disclosed herein can provide. According to specific examples herein, the user of the disclosed testing device need not have any expertise in how to perform various types of analysis on biological samples before the user can use the testing device to produce results. Therefore, the test device may include a processor for executing an automated analysis processing program on the sample and determine a result regarding the sample. The processor may be carried by a main circuit board (ie, known components, not shown for simplicity). In addition, the test device is preferably small and not as bulky as a conventional test device commonly found in laboratories. Therefore, in some specific examples, such as those shown in FIG. 19 and FIG. 20, the receiving mechanism of the carrier, the camera module, and the main circuit board may all be packaged in the housing of the test device. The test device may have a small appearance size, such as less than 30 centimeters (cm) × 30 cm × 30 cm, that is, 27,000 cm ³ . In some specific examples, the test device may further include a battery compartment enclosed in the housing, so that the battery can be installed in the battery compartment to power the test device.

In some specific examples, the processor included in the test device may perform different analysis on different holding regions, and may derive results based on a combination of results of analysis performed on different regions. In other words, the processor may be configured to execute a first analysis processing program on the captured image of the first holding area, and perform a second analysis processing different from the first analysis processing program on the captured image of the second holding area. Program, and determine the results regarding the biological sample based on the results of both the first analysis processing program and the second analysis processing program. As used herein, the term "analytic process" means that one or more fragments of information (e.g., images of holding areas) collected from many sources can be evaluated and produce results, conclusions, conclusions, The end result, estimate, or similar process.

According to some examples, the test device may use a combination of the first camera module 2230A, the light source 2240A, and the housing 2210A to quantify the analyte or determine the characteristics of the sample (eg, pH level, LH level, HCG level, or fructose level). In addition, the test device may further use a combination of the second camera module 2230B, the light source 2240B, and the magnifying component 2210B to analyze the enlarged image of the sample to determine the characteristics of the sample (eg, the number of sperm, motility, sperm morphology, etc.). Depending on the requirements of each type of biochemical test, different combinations or configurations of light sources can be used to illuminate biochemical samples. The multi-camera configuration is particularly beneficial because different analysis processing programs can be executed through different camera modules without requiring the user to change the carrier (for example, a test strip device), thereby speeding up the generation of results and reducing the complexity of necessary human operations. The light sources 2240A and 2240B are packaged inside the housing and configured to illuminate a biological sample for at least one of the camera modules. According to one or more specific examples, the processor is configured to control the light source based on an analysis processing program that the processor is currently configured to execute.

In addition, in some specific examples, the processor may execute different analysis processing programs based on the visual cue on the carrier. For example, some specific examples may perform image recognition and processing on the image of the holding area, and may perform different analysis processing programs according to visual cues from the results of image recognition. Example vectors 2905 (1) to 2905 (4) are shown in FIG. 29, where the vector 2905 (1) is used for a fertility test (eg, via its sperm) on the germ cells of a male subject, and the vector 2905 ( 2), 2905 (3), and 2905 (4) are used for fertility testing on female subjects' germ cells (eg, via their urine). As shown, the carriers 2905 (1) to 2905 (4) all have a first holding area 2915A corresponding to the position of the first camera module 2230A, but only the carrier 2905 (1) includes a second holding area 2915B. In some examples, the visual cue on the carrier may be the shape of a specific holding area (eg, holding area 2215A). For the discussion herein, the shape of the holding area means the entire edge (or outer periphery) of the holding area. For example, the shape may be a circle, an oval, a triangle, a rectangle, or a processor using a known image processing technology, as described by an individual camera module (for example, the first camera module 2230A). Any suitable shape recognizable on the captured image of the holding area. Additional examples of visual cues may include graphic patterns, visual signs, one-dimensional bar codes, multi-dimensional pattern codes (e.g., QR codes), and the like.

Referring to FIG. 22 and FIG. 29 at the same time, in some specific examples, when the processor recognizes (eg, via the first camera module 2230A) the first holding area (eg, the area 2215A or the area 2915A of the carrier 2905 (1)) is When in a shape (e.g., circular), the processor is configured to perform a certain analysis process (e.g., fertility of a male subject, such as according to various characteristics of his sperm sample), and when the first holding area (carrier When area 2215A or area 2915A of 2905 (2) is in a second shape (e.g., oval), the processor will perform different analysis processes (e.g., analysis of fertility of a female subject, such as Fluid samples). In this way, the test device is not limited to performing only one type of test (e.g., fertility of sperm), but it can also switch the analysis processing program accordingly based on the carrier (e.g., test strip device) inserted into the machine.

More specifically, according to some implementations, when the shape indicates that the biological sample includes sperm from a male subject, the processing program may determine one or more characteristics of the sperm, such as those characteristics introduced herein. In some examples, the determination of one or more characteristics of the sperm may be performed by using the second camera module 2230B. For some specific examples, the identifiable characteristics may include: sperm concentration, motility of the sperm, and / or morphology of the sperm. According to some specific examples, the processor is configured to (1) determine the concentration and / or morphology of the sperm based on a single image in the captured image, and (2) based on two or More than two images determine sperm motility.

In view of the above, FIG. 30 is a flowchart of an example processing procedure 3000 for analyzing fertility of both male and female subjects using the test device disclosed herein (eg, in FIG. 22). With continued reference to FIG. 29, the processing procedure 3000 is described below. It should be noted that the following example applies a male sample first, followed by a female sample, but the reverse order (ie, female and then male) can be performed without affecting the accuracy of the results.

First in step 3002, a user may apply a biological sample (e.g., sperm) of a male subject to a first holding area (e.g., area 2915A) of a first carrier (e.g., carrier 2905 (1)) and a second Holding area (area 2915B). Next, in step 3004, the user inserts the first carrier into the test device (for example, one shown in FIG. 22), and because the shape of the first holding region 2915A of the carrier 2905 (1) is circular, the test The device can automatically acquire knowledge that the current sample contains sperm from a male and select an analysis processing program accordingly. Next, in step 3006, the user may determine one or more characteristics of the sperm using a testing device. For example, as discussed herein, the processor in the test device may utilize the first camera module 2230A to obtain an image of the first holding area 2915A of the carrier 2095 (1) (the carrier 2095 (1) may include a response to Test strips of different colors are shown with different acidity), and the color of the test strips is identified to determine the acidity of the sperm. In addition, in step 3006, the processor in the test device may use the second camera module 2230B to determine one or more characteristics of the sperm selected from the group consisting of: the number of cells (such as the number of sperm), and the concentration of the sperm. , Sperm motility and sperm morphology.

Next, in step 3008, the user may apply urine from the female subject to the holding area 2915A of the second carrier (eg, carrier 2905 (2)). In step 3010, the user inserts the second carrier into the test device, and because the shape of the first holding area 2915A of the carrier 2905 (2) is oval, the test device can automatically obtain the current sample containing urine from a female. Knowledge and choose the analysis handler accordingly. In step 3012, the test device determines one or more characteristics of the urine, for example, by using the second camera module 2230B. For example, a test strip may be suitable to enable a test device to determine the concentration level of one or more types of female hormones (eg, FSH, LH, or HCG). Finally, in step 3014, the user uses the test device to automatically analyze the results of the male and female biological samples and determine the final result regarding the fertility of the subject.

In some specific examples, the first camera module 2230A may have a lower camera resolution than the second camera module 2230B, and thus the two cameras are used by a processor to execute different analysis processing programs. In addition, the first camera module 2230A may have a lower magnification ratio than the second camera module 2230B. Some examples of the first camera module 2230A may not have a zoom function at all, and the second camera module 2230B may have a fixed zoom ratio. Additionally or as an alternative to the second camera module 2230B, which has a higher magnification ratio itself, the housing 2210B of the second holding area 2215B may include a magnifying component, such as shown in FIG. 22. In some implementations, the magnification ratio of the camera module may be adjustable (eg, controlled by a processor). Some examples of the test device specify that the first camera module 2230A has a camera resolution of 2 megapixels or higher, and the second camera module 2230B has a camera resolution of 13 megapixels or higher. In some examples, the second camera module 2230B may include a linear magnification ratio of at least 4.8 times or more.

In some of these examples, the processor further determines at least one additional characteristic of the sperm by using the first camera module 2230A. This additional characteristic may include the acidity of the sperm. For example, the carrier may include a pH indicator in the first holding region 2215A using a color to indicate the acidity of the sperm, and the processor may recognize the color to identify the acidity. Similarly, some examples provide that the processor can determine the biochemical characteristics of the biological sample based on the color of an area in one or more images of the first or second holding area.

Continuing with the above test device example with a multiple camera configuration in FIG. 22 and the carrier example in FIG. 29, in some implementations, when the processor recognizes a first holding area (e.g., area 2215A or carrier 2905 (2) When area 2915A) is in a second shape (such as an oval shape) that can indicate that the biological sample includes urine from a female subject, the processor is configured to determine one or more characteristics of the urine. Determinable characteristics may include: LH level levels, FSH levels, and / or HCG levels. As with acidity, determination of one or more characteristics of urine can be performed by using a first camera module. Similarly, the carrier may include an LH indicator (e.g., as shown in carrier 2905 (3)), an FSH indicator (e.g., as in carrier 2905 (2) Shown in) and / or HCG indicator (for example, as shown in carrier 2905 (4)).

Further, in some specific examples, the processor may utilize at least one of the two camera modules (eg, the first camera module 2230A) or another sensor (eg, the light sensing introduced below with respect to FIG. 26) 2690) to determine the preparation status or validity of the biological sample before executing the analysis processing program. In some implementations, the preparation status of the test sample can be determined based on identifying whether the first visual mark is displayed in a specific area (e.g., where line 2916 is shown in FIG. 29) in the first holding area (e.g., area 2915A) Or effectiveness. An example of this first visual sign may be a line displayed in a specified area on the test strip, such as shown as a red line 2916 in FIG. 29. Red line 2916 can be used as a quality control component, which can indicate that the test is valid or the result is ready. In addition, the first holding region 2915A may include another region (for example, where a line 2917 is shown in FIG. 29) that displays a second visual mark indicating a test result regarding a characteristic of the biological sample. An example of this second visual mark may be a line displayed in another designated area on the test strip in a ready state, such as shown as a red line 2917 in FIG. 29.

In some specific examples, the test device may perform an action in response to a determination that the biological sample is not ready. In some examples, the actions performed by the processor include implementing a timer with a duration determined by the analysis processing program to be executed. In some other examples, the testing device further includes a moving mechanism, and a processor in the testing device may use the moving mechanism to apply mechanical force to the carrier to improve the readiness of the biological sample. More details about the actions and mechanisms that can be implemented in the test device are introduced below with respect to Figures 25 (Figures 25A and 25B) and Figure 26 (Figures 26A and 26B).

The positions of the magnification components (eg, the magnification components of the camera module or the magnification components of the test strip) and the positions of the light sources can be adjusted or selected according to the requirements of various types of analyte analysis. In a variant, the camera modules may have an adjustable magnification ratio. In at least some of these examples, the processor is further configured to adjust a magnification ratio of at least one of the two camera modules based on an analysis processing program that the processor is currently configured to execute. As introduced above, when the biological sample includes sperm, the test device can be configured with a suitable camera module (eg, the second camera module 2230B) to achieve different magnification ratios for determining the motility of the sperm and the shape of the sperm.

It should be noted that the optimal distance between the camera module and the magnification component may have a low error margin. For example, even a small deviation of 0.01 mm from the optimal distance can prevent the camera module from capturing a clear image of the sample holding area. In order to finely adjust the distance between the camera module and the magnifying component, the test device may include an automatic focus (AF) function. The autofocus function is a function of automatically adjusting an optical system (for example, adjusting a distance between components of the optical system) so that an object being imaged (for example, semen) is within a focal plane of the optical system. At least one or more specific examples also provide a mechanical focusing mechanism that can be controlled by the processor so that at least one of the two camera modules is focused on an individual holding area. The mechanical focusing mechanism is discussed in more detail below with respect to FIGS. 23 and 24. The mechanical focusing mechanism may be controllable to adjust the position of the lens in at least one of the two camera modules (for example, shown generally in FIG. 23). Additionally or alternatively, the mechanical focusing mechanism may be controllable to adjust the position of the carrier (e.g., generally shown in Figure 24).

FIG. 23 is a schematic diagram of components of a test apparatus having an autofocus function. As shown in FIG. 23, the test device can move the camera module up or down along the Z axis (for example, by a motorized track, an ultrasonic motor drive, or a stepper motor). By adjusting the vertical position of the camera module, the test device can adjust the distance between the camera module and the magnifying component.

FIG. 24 is a schematic diagram of components of another test apparatus having an auto-focus function. As shown in FIG. 24, the test device can move the test strip device up or down along the Z axis. By adjusting the vertical position of the test strip device, the test device can adjust the distance between the camera module and the magnifying component.

During the autofocus operation as shown in FIG. 23 or FIG. 24, the camera module and the supplementary lens remain as a single module. In other words, the distance between the camera module and the supplemental lens remains unchanged during the autofocus operation as shown in FIG. 23 or FIG. 24.

25B is a B-B cross-sectional view of the test device including a switch and a motor in FIG. 25A. A B-B cross section of the test device 1900 in FIG. 25B illustrates various components of the test device. The test device 1900 includes a switch 2550 for detecting a collection bottle 2510 inserted into the test device 1900. When the collection bottle 2510 is inserted, the switch 2550 is activated. The collection bottle 2510 is then notified to the test device 1900 via the switch 2550. Based on the time period during which the switch 2550 is activated, the test device may determine the time period during which the collection bottle 2510 remains inserted.

The test device 1900 further includes a motor 2560 for shaking, shaking, or rotating the collection bottle 2510 to mix the samples in the collection bottle 2510. The test device 1900 may include a camera 2570 to determine whether a sample has been liquefied based on a captured image of the sample in the collection bottle 2510.

Fig. 26B is a schematic cross-sectional view taken along the line C-C of the test device including a flexible element in Fig. 26A. A B-B cross section of the test device 1900 in FIG. 26B illustrates various components of the test device. The test device 1900 includes a moving element 2680 (eg, an elastic assembly) at the bottom of a slot for receiving the collection bottle 2610 in a mobile manner. For example, the moving element 2680 may include a spring that spontaneously recovers its normal shape after being contracted or deformed. When the collection bottle 2610 is inserted into the slot, the moving element 2680 is compressed. The light sensor 2690 (or other type of distance sensor) is responsible for detecting the distance between the light sensor 2690 and the bottom of the collection bottle 2610. Based on the distance between the light sensor 2690 and the bottom of the collection bottle 2610, the test device 1900 can determine the weight or volume of the sample contained in the collection bottle 2610. For example, the distance between the light sensor 2690 and the bottom of the collection bottle 2610 may be inversely proportional to the weight or volume of the sample contained in the collection bottle 2610.

In some other specific examples, the test device 1900 may include a sensor on the top of the collection bottle 2610. The sensor can detect the distance between the sensor and the top of the collection bottle 2610. The weight or volume of the sample contained in the collection bottle 2610 may be determined based on the distance, since the volume or the weight may be, for example, proportional to the distance between the sensor and the top of the collection bottle 2610. Then, based on the weight or volume of the sample, the test device 1900 may determine a time period for which the sample in the collection bottle 2610 is waiting to be liquefied. The test device 1900 further includes a motor 2660 for shaking, shaking, or rotating the collection bottle 2610 to mix the samples in the collection bottle 2610.

In some specific examples, the camera module of the test device may include a light field camera (not shown) that captures the intensity and direction of light. The light field camera may include a micro-lens array or a multi-camera array in front of the image sensor to detect direction information. Using the direction information of the light, the camera module can capture clear images at a wide range of focal planes. Therefore, the test device using a light field camera may not need an auto-focus function to finely adjust the distance between the camera module and the magnifying component.

In view of the above, the device of the present invention is suitable for testing male fertility and / or female fertility.

The invention provides a method for testing male fertility using the device of the present application. The method includes the steps of: applying a biological sample from a male subject to the first holding region and the second holding region of the carrier; inserting the carrier into the device; determining the acidity of the sperm according to the first analysis processing program; Two analysis processing programs determine one or more characteristics of sperm selected from the group consisting of: sperm concentration, sperm motility and sperm morphology; and analysis results to determine male fertility.

The invention also provides a method for testing female reproductive hormones using the device of the present application. The method includes the steps of: applying a biological sample from a female subject to a first holding area of a carrier; inserting the carrier into a device; and determining a concentration level of one or more types of a female hormone, the female hormone Such as luteinizing hormone (LH), follicle stimulating hormone (FSH), or human chorionic gonadotropin (HCG).

The invention further provides a method for testing fertility of a pair of male and female subjects. The method includes the steps of: applying a biological sample from a male subject to the first holding area and the second holding area of the first carrier; inserting the first carrier into the device; and determining the sperm's Acidity; one or more characteristics of sperm selected from the group consisting of sperm concentration, sperm motility, and sperm morphology according to a second analysis processing program; applying a biological sample from a female subject to the An area for holding the second carrier; inserting the second carrier into the device; determining the concentration level of one or more types of estrogen; and the results of analyzing male and female biological samples.

FIG. 27 is a flowchart of a processing procedure for analyzing a semen sample of a male client or patient. A system for analyzing a semen sample may include a test machine (e.g., test device 1900), a mobile device, and a cloud server. FIG. 28 is a flowchart of a processing procedure for analyzing LH or HCG of a female client or patient. A system for analyzing LH or HCG may include a test machine (eg, test device 1900), a mobile device, and a cloud server. The flowcharts of FIGS. 27 and 28 illustrate steps performed by the test machine, mobile device, and cloud server, and information passed between the test machine, mobile device, and cloud server.

In some specific examples, the method for testing sperm comprises the steps of: obtaining a device for testing a biological sample, applying a sperm sample to a sample holding area, recording a video or image of the sperm sample; based on the recorded video or recorded Determine the sperm count of the sperm sample with at least one frame of the image; and determine the sperm motility of the sperm sample based on the recorded video or the recorded image.

In a related specific example, the method further includes waiting for a predetermined period of time for the liquefaction of the sperm sample before applying the sperm sample to the sample holding area.

In another related specific example, the method further includes: placing a mobile device including a camera component on top of the device such that the camera component is aligned with the magnifying component and the sample holding area; and receiving by the mobile device The light signal from the sperm sample is amplified by the amplification component in the sample holding area.

In yet another related specific example, the method further comprises: illuminating the sample holding area by a lateral illumination device disposed on one side of a carrier of the device or a vertical illumination device disposed on or under the carrier of the device. .

In yet another related specific example, the method further includes: directing a light beam from the lateral illumination device through a carrier made of a transparent or translucent material; and by a plurality of light reflection patterns included in the carrier Reflects the light beam to the sample holding area.

In yet another related specific example, the method further comprises: inserting a disposable test device into a base, the base including a camera assembly for recording video of a sperm sample or a form-fitting frame for fixing a mobile device, The mobile device includes a camera component for recording video of a sperm sample.

In yet another related specific example, the method further includes: extracting at least one frame from the recorded video of the biological sample; identifying a plurality of sperm from the at least one frame; and based on the number of identified sperm and the at least one frame The recorded area was counted for sperm count.

In yet another related specific example, the method further comprises: analyzing the shape of the identified sperm; and determining a morphological level based on the shape of the identified sperm.

In yet another related specific example, the method further includes: extracting a series of video frames from recorded video of a sperm sample; identifying a plurality of sperm from the series of video frames; identifying sperm movement based on the series of video frames Trajectory; determining a sperm's moving speed based on the sperm's moving trajectory and the time period captured by the series of video frames; and calculating sperm motility based on the sperm's moving speed.

In yet another related specific example, the method further comprises: further magnifying the video or image of the sperm sample via a magnifying lens.

In some specific examples, a method for testing sperm using a system for testing a biological sample includes: inserting a device into a base assembly; and recording a video of a sperm sample in a sample holding area by a mobile device, said The mobile device is fixed in the shape-fitting frame of the base assembly; the sperm count of the sperm sample is determined based on at least one frame of the recorded video; and the sperm motility of the sperm sample is determined based on the recorded video.

In a related specific example, the method further comprises: further magnifying the video of the sperm sample via a magnifying lens.

In some specific examples, a system for testing a biological sample includes a disposable device and a base assembly for testing the biological sample. The disposable device includes a sample carrier containing a sample holding area and a removable cover placed on top of the sample holding area. The base assembly includes an insertion port for inserting a disposable device into the base assembly, and a camera assembly for capturing an image of a sample holding area, the camera assembly including an image sensor and an optical lens module . In a related specific example, the optical lens module may have a linear magnification ratio of at least 0.1.

FIG. 31 shows an additional example carrier 3105 having one or more visual signs 3117 (1) -3117 (5) (or may be collectively referred to as visual cue 3117) that can be used to control the analysis processing program (e.g., 21C or 22). As shown in FIG. 31, the visual cue 3117 may be in (or near, in some additional or alternative embodiments) a holding area of the carrier 3105 (eg, holding area 3115B).

As before (for example with respect to FIG. 29), the processor may execute different analysis processing programs based on visual cues on a carrier. For example, in some specific embodiments, image recognition can be performed and the image of the holding area can be processed, and different analysis processing programs can be executed according to the visual cue from the result of the image recognition. In some embodiments, the visual cue of the carrier may be a shape of a specific holding area. Additional visual cue embodiments may include graphic patterns, visual signs, one-dimensional bar codes, multi-dimensional pattern codes (eg, QR codes), and the like.

In some specific examples, as shown in FIG. 31, any visual mark (such as visual mark 3117 (1)) can be a specific small graphic pattern that can be engraved, attached, or marked in a holding area in the carrier 3105. 3115B. In the example of FIG. 31, the visual signs 3117 (1) -3117 (5) are all the same or substantially similar patterns, but in other examples (not shown for simplicity), they need not be exactly the same and each visual Logos can have unique shapes, sizes, patterns, etc. In one or more implementations, the visual cue 3117 (e.g., visual signs 3117 (1) -3117 (5)) is a size that is not perceived by humans but can be recognized by a camera module through a microlens (e.g., The second camera module 2230B in FIG. 22 or the camera module 2130 in FIG. 21C). In some of these implementations, the visual signs 3117 (1) -3117 (5) are less than 15 micrometers (µm). In addition, the visual signs 3117 (1) -3117 (5) can be configured such that their positions collectively form a Pattern (for example, a predetermined configuration). In addition or as an alternative to characteristics specific to visual signs (such as size, shape, color, and / or position), the collective pattern formed by the position of each visual mark can be a identifiable prompt to be used to control the test device's Function (for example, what kind of analysis processing routine is executed continuously). This collective pattern may be based on the absolute position of the visual signs (e.g., in the holding area) and / or the relative positions of the visual signs (e.g., from their respective neighboring signs). In FIG. 31, the collective pattern shown by the visual signs 3117 (1) -3117 (5) is that each of the visual signs 3117 (1) -3117 (4) is set in one of the four corners of the (image captured by the camera) and The visual mark 3117 (5) is set at the center, and each visual mark is evenly distributed. Some additional or alternative embodiments provide that each (or each group) of special visual indicia (or logos) in the visual cue may represent a different analysis function to be performed.

In view of the above, the test device here can utilize visual cues on the carrier (for example, in or near the holding area) to control the function of the test device and adaptively execute the analysis processing program based on the visual cues. In some embodiments, visual cues can be used to confirm whether the carrier is an authorized carrier (e.g., appropriately licensed and manufactured under a certain specification and in accordance with applicable quality standards). In other examples, visual cues can be used to control the mode in which the test device performs calculations (eg, male or female, laboratory or home, high accuracy or short time, using batteries or plugging in). In addition, in some embodiments, providing a visual cue can be used to control access to a certain function of the test device, which provides the ability to flexibly customize the services provided by the test device based on the identity of the customer, geographic location, and the like.

FIG. 32 is a flowchart of another example of a processing program 3200 that can be implemented by a testing device (such as in FIG. 21C or FIG. 22) based on visual cue adaptively executing an analysis processing program. With continued reference to FIG. 31, the processing routine 3200 is described below. It should be noted that, in the following example of the processing program 3200, the visual cue is applied to execute a carrier authentication application, but the processing program may be similarly applied to execute other applications (for example, as described in relation to FIG. 30). For example, in some applications that are not carrier verification, the processor may execute different sets of analysis processing programs based on different visual cues.

First, in step 3202, the receiving device of the testing device receives the carrier inserted through the opening. The sensor (not shown for simplicity) can notify the processor, and the processor will cause the built-in camera module of the testing device to capture An image of one or more carrier holding areas. At step 3204, the processor may utilize visual cues in the carrier to identify the captured images (such as based on known image analysis techniques or those disclosed herein). As discussed above, the visual cue may include some visual signs, each visual sign may be the same or different size, shape, pattern, color, etc. (as shown in the example shown in FIG. 31) or they may be different. The visual signs can collectively further present a pattern (eg, from their location). The processor can then combine visual cues (such as a unique size, shape, location, or collection pattern) with predetermined visual cues (such as stored in local memory and / or a cloud database (available by the manufacturer of the test device) Or other administrator actions or controls).

In step 3206, the processor selectively executes a set of analysis processing procedures on the recognition result of the captured image of the holding area based on the visual cue. If the recognition result of the visual cue responds positively (for example, in response to a carrier holding area with a predetermined visual cue), then the processor proceeds to include optional acquisition of additional images (or videos) for analysis (step 3208) and subsequent steps of the corresponding group (step 3210) of performing an analysis processing program on the image. On the other hand, if the recognition result responds negatively (for example, in response to a carrier holding area that does not have a predetermined visual cue), the processor causes an alternative action (e.g., displays an error code) to reflect that the visual cue is unrecognizable and wrong The image executes any analysis processing program (step 3212). After the analysis processing program group is executed, the processor may continue to determine the result about the biological sample based on the result of the analysis processing program as described above.

In addition, it is worth noting that traditional computer-assisted sperm analyzers (CASA) rely on the experience of large microscopes and operating technicians to determine sperm parameters. There is some computer software to supplement the experience of technicians and to standardize the analysis results. However, due to different lenses and sensing modules, blurred images often seriously affect the effectiveness of auxiliary software, resulting in inaccurate related functions (such as sperm count calculation).

In addition, competent authorities such as the World Health Organization (WHO) have published a manual for human semen inspection and processing laboratories, which specifies the minimum sample size to be evaluated to determine sperm concentration, motility and sperm morphology. (For example, 200 sperm). Existing computer-assisted sperm analysis image analysis generally lacks automatic sampling or requires manual operations to obtain multiple fields of view to meet WHO specifications and reduce sampling errors in the analysis. Alternatively, if sampling is performed repeatedly with a single field of view In order to achieve a satisfactory low sampling error, the time it takes to repeat the procedure often becomes too long to achieve on a large scale.

FIG. 33 is a flowchart of an example processing procedure 3300 that can be implemented by a test device (eg, FIG. 21C or FIG. 22) here for better results (eg, better analysis accuracy or efficiency). The processing program 3300 may be an alternative or supplementary processing program of the processing program here (for example, the processing program shown in FIG. 16).

First, step 3310 (for example, after a carrier box carrying the biological sample or which has been exposed to the biological sample is inserted (as introduced above)), the introduced device may use a camera module to capture a carrier box holding area One or more images (or collectively referred to as an imagery). In some alternative embodiments (e.g., as described with respect to FIG. 29 or 31), the device may identify (step 3320) a visual cue on the carrier from the captured set of images of the holding area. In these alternative embodiments, the device may perform a set of analysis processing procedures on the captured set images based on the recognition results of the visual cue.

In step 3330, the device may divide the captured set image into a plurality of blocks. In some embodiments, the blocks may be polygonal. More specifically, some implementations indicate that blocks can be triangles, rectangles, squares, pentagons, hexagons, and so on. These (block) shapes may be 0.05 mm on at least one side. In one or more embodiments, the block is square and has a size of 0.05 mm by 0.05 mm. It is worth noting that, depending on the specific implementation, the number and size of the blocks can be adjusted according to the resolution of the camera module. An example of an image indicating a holding area is illustrated in FIG. 34 as being divided into blocks (for example, block 3402). It should be noted that in order to facilitate the discussion of the disclosed techniques herein, the retrieved collection image is considered to be "segmented" into blocks; however, it should be understood in one or more implementations that the processor is operating at computer time (Or during normal operation) does not actually require a mathematical division operation to perform this technique; rather, the resulting block or grid can be predetermined, logically pre-connected, programmatically preset, or pre- Configured on the device's camera controller and / or processor, the need to perform operations related to the collection of images into segments can be reduced or completely eliminated in some instances.

In step 3340, the example device selects from a plurality of blocks and candidate blocks for analysis. According to one or more embodiments, the selection of candidate blocks is based on many factors, such as the degree of focus of a block and / or the normality of a block.

More specifically, in many implementations, this device can determine (step 3342) the degree of focus of each complex block, so that each block can have a corresponding degree of focus measurement. This degree of focus can be determined based on one or more focal length measurement functions. Depending on the implementation, the adopted focal length measurement functions may include one or more of: a variation type, a difference coefficient sum type, a Laplacian energy image type, and / or a side gradient intensity maximization type.

After determining the focus degree of each block, in some embodiments, the device compares the focus degree of a block with a minimum focus degree threshold. In one or more implementations, a block can be selected as a candidate block only if the degree of focus meets (eg, reaches or exceeds) a minimum focus degree threshold. In addition, the device can also mark or label blocks. This device states in one or more embodiments that blocks are only marked or numbered when the minimum focus level threshold is met (for example, for further analysis or tracking identification). Marking or labeling can be done continuously or randomly. The selection process of a part of the candidate blocks is illustrated in FIG. 35. Here, the blocks are randomly labeled, and the blocks exceeding the minimum focus degree threshold are initially selected as the candidate blocks 3510.

Next, the device may execute an image processing program on the selected blocks to determine the characteristics of the selected blocks (step 3344) to determine the normality of a block, such as checking whether the block is " Normal enough "to grant further analysis. In some examples, the blocks selected for normality determination are those that have been initially selected as candidate blocks (eg, those that meet the minimum focus level threshold, as explained above). In some instances, this stage is used to determine the normality characteristic is the number of cells (such as sperm count). In a specific example, this device can perform an image processing program on the blocks that satisfy the minimum degree of focus (meaning that they are sufficiently focused) to determine the number of cells (sperm) within the block for each sufficiently focused block. This image processing program may include binarization (and in some implementations, with adaptation limits) to identify objects in the block that may be sperm as the foreground, and identify the remainder of the block as the background, After the image processing program, the device can determine the number of cells (sperm). In one or more embodiments, the number of cells in the candidate block can be determined based on the area ratio of sperm to non-sperm (eg, extrapolation using a table related to known cell number ratios).

This device is then able to calculate statistics (e.g., average and standard deviation) for all remaining candidate blocks (e.g., those blocks that meet the minimum focus level threshold). After the statistical data is calculated, the device can determine (step 3344) the normality of the specific block by statistically comparing one or more characteristics (for example, sperm count) of the specific block and all remaining candidate blocks. In some embodiments, only when the normality of a specific block satisfies a normality condition, will it continue to be selected as a candidate block. Take the number of spermatozoa as an example. In many embodiments, a block is considered "normal enough" (for example, to meet normality conditions). Standard deviation in preset values. In one or more implementations, the requirement for normality is (in average terms) within two standard deviations. In other implementations, the normality requirement is one or three standard deviations, or other suitable statistical techniques, which can reflect the comparison of the normality of a block with other block groups. It is illustrated in FIG. 36, which is the result after the image processing program (for example, adaptive thresholding binarization) and the cell number determination. It should be noted that in FIG. 36, the estimated cell number of each candidate block is shown to replace its flag.

In addition, the device can determine (step 3346) whether the target number of cells to be analyzed has been reached. In particular, one or more embodiments of the disclosed device are capable of maintaining the total cell number, and for each block selected as a candidate block, the device adds the corresponding cell number of the block to the total cell number. The device can use the target number of analysis cells to control the number of biological samples to be analyzed, and the number is configurable according to the implementation. This quantity (number) can be customized according to laboratory manuals and standards for testing specific biological samples. In some embodiments, the target number of cells to be analyzed is two hundred (200). In some instances, when the total number of cells reaches the target number of cells to be analyzed, the selection of candidate blocks is complete. That is, according to at least some embodiments disclosed herein, the selection of candidate blocks can be performed on blocks that meet the normality requirements of the focus degree threshold and the total number of cells reaching the target number of cells to be analyzed ( (For example, in a random manner).

At step 3350, after the candidate block is selected, the introduced device may determine one or more characteristics of the biological sample by analyzing the selected candidate block (eg, by one or more techniques introduced herein). In at least several embodiments, the biological sample is semen, and one or more characteristics of the biological sample in the candidate block are to be determined, including one or more: the number of cells (or concentration, which can be inferred from the number of cells) , Activity, or form. In some examples, the device is further configured to determine a result (eg, fertility) regarding the biological sample based on the results of the analysis processing program after the analysis processing program is executed.

In addition, it is observed here that it is often difficult (especially when the volume is large and cost control is required) to make a perfect lens assembly, such as a micro lens assembly and / or magnification mounted on a test device introduced here Lens assembly. Lens flaws exist in a variety of forms, such as impurities, or imperfections in the lens itself (for example, clarity, refraction, focus, and others), and these flaws can adversely affect the accuracy of the test device influences. Therefore, introduced here is the technology of correction and inspection to reduce lens defects and further improve the analysis accuracy of the test device disclosed herein.

FIG. 37 is an example flowchart 3700 of an example correction processing program, which can be implemented by a test device disclosed herein (eg, FIG. 21C or FIG. 22) to obtain improved results. This processing program 3700 may be an alternative or supplementary processing program to the process disclosed herein, such as the processing program illustrated in FIG. 16.

First, in step 3710 (for example, after the carrier box is inserted), the introduced device can use a camera module to capture one or more images (or collectively referred to as a collective image) of the holding area of the carrier box. Like (imagery)). In some alternative embodiments (for example, those with a description of FIG. 29 or 31), the device can recognize the visual cues on the carrier (step 3720) by a collection of images taken from the holding area. In these alternatives, In an embodiment, the device may perform a set of analysis processes on the captured set images according to the recognition result of the visual cue.

More specifically, in some implementations, the carrier box herein can be used as a special virtual box to trigger the correction processing program. For example, a special virtual box may have one or more special graphic patterns (for example, described below with respect to FIG. 38), which can trigger the test device to enter after a visual cue recognition process (for example, in step 3720). Calibration mode. In another example, a dedicated virtual box can carry a dedicated test sample (for example, described below with respect to FIG. 41), and the user can manually create (for example, through a user interface on the panel or a remote test device) the test device to enter Calibration mode. In many instances, the virtual box may include an electronic (eg, a radio frequency identification (RFID)) or a mechanical feature (eg, a special shape or a mechanical protrusion) that can trigger a correction mode.

FIG. 38 is a test carrier carrying a visual cue or an image pattern, which can be used to calibrate or verify the test device disclosed herein. In one or more embodiments, the visual cue includes an image pattern that enables the test device to recognize as a trigger to enter the calibration mode. Afterwards, the test device can use the camera module to capture the image of the image pattern, and perform self-diagnosis to self-correct from the results in the captured image. Visual patterns should be easily identifiable (and not easily misidentified). As illustrated in Figure 38, the visual pattern in the example includes repetitive (for example, every 0.08 millimeters, that is, repetition rate or "pitch"), larger (for example, 0.02 millimeters by 0.02 millimeters), and general The ground has a regular shape. This visual cue can further include one or more repeating linear styles. In the example illustrated in Figure 38, this linear style contains a set (eg, three) of horizontal lines and a set (eg, three) of vertical lines. In some embodiments, the lines have a resolution of 200 line pairs / mm (LP / mm) or higher. In the specific example of FIG. 38, the lines have a resolution of 500 LP / mm. It should be noted that horizontal and / or vertical lines are examples of visual linear patterns that are suitable to assist the test device to perform self-diagnosis of the optical characteristics and performance of specific optical instruments (eg, microlenses) mounted on the test device itself; other A suitable visual pattern may replace the illustrative example in FIG. 38. For example, in some implementations, an "E" shaped pattern or equivalent can be used as a visual linear pattern instead of parallel lines. For example, in some implementations, solid and dashed lines can be used for visual linear patterns.

Continue to process 3700. Although the correction mode has been triggered in step 3730, after the carrier collection image is captured (for example, in step 3710), the device can segment the captured collection image into plural blocks (this and Step 3330 is similar, as discussed above). In some embodiments, the blocks may be polygonal. More specifically, some implementations indicate that blocks can be triangular, rectangular, square, pentagonal, hexagonal, etc. These (block) shapes may have at least 0.05 mm on one side. In one or more embodiments, the block is square and has a size of 0.05 mm by 0.05 mm. It is worth noting that according to the specific implementation, the number and size of the blocks can be adjusted according to the resolution of the camera module. In one or more implementations, the above-mentioned pitch (for example, the visual pattern regularly repeats itself) can correspond to the number of blocks in which the set image can be segmented. In some embodiments, the pitch may be consistent with the number of blocks that the aggregate image can be divided by the test device.

At step 3740, the device in the example can perform a calibration / self-diagnosis procedure, such as in each block. The calibration procedure should usually be one or more steps that enable the test device to self-diagnose the quality of the optical module (for example, including a micro lens and camera module) currently installed on the test device itself. In one or more embodiments, the test device may determine (at step 3742) the degree of focus of each block, for example, by using one or more focal length measurement functions. Examples of the focal length measurement function may include a variation type, a difference coefficient sum type, a Laplacian energy image type, and / or a side gradient intensity maximization type. Then, in step 3744, the tester can determine whether a block satisfies the degree of focus, for example, the minimum focus degree threshold value discussed above. Additionally or alternatively, the test device can compare the retrieved results with one or more expected results (at step 3746). For example, the processor of this test instrument has access to one or more images pre-installed in memory (for example, not captured using a camera, for example, passed or installed by program default), and The captured images are compared and it is determined whether the quality of the captured images in question in the block meets the minimum standards. The pre-installed image or images should be representative of the visual pattern applied to the correction. In step 3746, the test device is able to compare and review the example image quality parameters, including color distortion, pattern distortion, sharpness defects, and / or other image defects.

FIG. 39 is a visual image of the example image of FIG. 38, which is captured by the testing device disclosed herein. Generally, the image quality is better toward the lower left corner and worse toward the upper right corner. 40A and 40B are two specific examples illustrating different image qualities of captured images in different blocks in FIG. 39. In some embodiments, for example, where the pitch is consistent with the number of blocks that can divide the set image, the images 40A and 40B can each represent a block. As illustrated, the image quality in the block of FIG. 40A is better than that of FIG. 40B because the image is clearer and more focused.

Back to the processing program 3700, in step 3750, the result of step 3740 (for example, whether the block meets the minimum image quality requirements, such as the minimum focus level) is recorded on the computer combined with the test device (not more details for simplicity) In a readable storage medium (for example, it may be non-transitory, such as flash memory). The knowledge gained from the calibration process can, for example, be used when the test device is used in normal operations thereafter. In one or more embodiments, during normal operation (eg, in step 3340, as discussed above), the test device may automatically skip or ignore those that fail to achieve the minimum image quality during calibration or self-diagnosis. The requested block. In this way, the test device disclosed herein can reduce the adverse reactions of lens defects and increase the accuracy of analysis.

Disclosed in FIG. 41 is an example image of a test carrier carrying a test sample, which can be used to calibrate or verify the test device disclosed herein. This technique can be applied in one or more of the aforementioned embodiments. A special virtual box can carry a special test sample and the calibration mode can be activated by a trigger other than the visual pattern (such as manual activation by a user, or by a mechanical Feature or radio frequency identification (RFID) on a virtual box). Some embodiments indicate that the test sample should be an aqueous medium (eg, a liquid solution) containing small test particles, such as test particles 4102 illustrated in FIG. 41. These particles can be made from any suitable substance, including, for example, polymers. A specific example of particle 4102 is latex. The size of the particles may be suitable for a particular application. In some implementations, the size of the particles can be similar to those of cells, such as sperm. Example particle sizes can range from 0.5 to 50 microns in diameter. In the example, the particles are 5 microns in diameter. When the test particle is used as a sample, the test device can perform a calibration / self-diagnosis without a step 3720, such as a 3700 processing program, and self-diagnose the quality of the optical module currently installed in itself. In some of these implementations, the test device can be pre-installed with images of test particles (eg, not captured by the camera, for example, by being transmitted or otherwise programmatically installed) in memory, as discussed above, to do For comparison and calibration purposes.

42A and 42B illustrate different image qualities in different blocks of the captured image in FIG. 41. As explained, the image quality in the block in FIG. 42A is better than that in FIG. 42B because the image is sharper and more focused. Similar to the above discussion, with regard to step 3750, the knowledge of the baseline image quality of each block can be used, for example, when the test device is later used in normal operation. For example, some embodiments of the test instrument may automatically skip or ignore blocks or self-diagnoses that fail to meet the minimum image quality conditions during calibration. In this way, the test device disclosed herein can reduce the adverse reactions of lens defects and improve the accuracy of analysis.

Although some of the specific examples disclosed herein apply the disclosed technology to sperm testing, those familiar with the technology will readily understand that the disclosed technology can be applied to the testing of various types of biological samples, such as semen, urine, Sliding synovial fluid, surface tissue or cells, tumor cells, water samples, etc.

It will be apparent to those skilled in the art that various modifications and variations can be made in the structure of the present invention without departing from the scope or spirit of the invention. In view of the foregoing, it is intended that the present invention cover the modifications and variations of the present invention as long as they fall within the scope of the following patent applications and their equivalents.

5‧‧‧test strip

10‧‧‧ carrier

11‧‧‧ sample holding area

12‧‧‧Sample receiving port

13‧‧‧air passage

14‧‧‧ protruding parts

15‧‧‧ Flexible transparent film

16‧‧‧ Beam Assisted Guiding Structure

20‧‧‧ Cover

21‧‧‧Groove

30‧‧‧ Magnification

30B‧‧‧ Magnification

30C‧‧‧Enlarged part

31‧‧‧ Zoom in

40‧‧‧sample

42‧‧‧Sample Collection

42A‧‧‧Sample collection area

50‧‧‧Side Lighting

60‧‧‧Smart communication device

61‧‧‧ Camera

70‧‧‧Instrument

71‧‧‧Lower barrel base

72‧‧‧ Upper barrel body

73‧‧‧Insertion port

74‧‧‧Magnifying lens

75‧‧‧Assembly frame

76‧‧‧ camera alignment hole

80‧‧‧ light source

92‧‧‧ non-slip film

94‧‧‧pH test paper

96‧‧‧ release paper

98‧‧‧Isolated components

1505‧‧‧step

1510‧‧‧step

1515‧‧‧step

1520‧‧‧step

1525‧‧‧ steps

1530‧‧‧step

1540‧‧‧step

1545‧‧‧step

1550‧‧‧ steps

1555‧‧‧step

1605‧‧‧step

1610‧‧‧step

1615‧‧‧step

1620‧‧‧step

1625‧‧‧step

1630‧‧‧step

1705‧‧‧ sperm

1710‧‧‧ Track

1720 ‧ ‧ trajectories

1805‧‧‧Track

1810‧‧‧curve speed

1815‧‧‧Straight speed

1820‧‧‧ Lateral head displacement

1825‧‧‧Average Path

1900‧‧‧test equipment

1905‧‧‧test strip device

1910‧‧‧ Collection Bottle

1920‧‧‧screen

2000‧‧‧test device

2005‧‧‧Test strip device

2105‧‧‧Test strip device

2110‧‧‧ Magnification

2115‧‧‧Sample holding area

2130‧‧‧ Camera Module

2135‧‧‧Lens

2140‧‧‧light source

2205‧‧‧Test strip device

2210A‧‧‧Cover

2210B‧‧‧Amplification Kit

2215A‧‧‧First holding area

2215B‧‧‧Second Holding Area

2230A‧‧‧First camera module

2230B‧‧‧Second Camera Module

2240A‧‧‧Light source

2240B‧‧‧Light source

2510‧‧‧Collection Bottle

2550‧‧‧Switch

2560‧‧‧Motor

2570‧‧‧Camera

2610‧‧‧ Collection Bottle

2660‧‧‧Motor

2680‧‧‧mobile components

2690‧‧‧light sensor

2905 (1) ‧‧‧ carrier

2905 (2) ‧‧‧ carrier

2905 (3) ‧‧‧ carrier

2905 (4) ‧‧‧ carrier

2915A‧‧‧First holding area

2915B‧‧‧Second Holding Area

3000‧‧‧Processing Procedure

3002‧‧‧step

3004‧‧‧step

3006‧‧‧step

3008‧‧‧step

3010‧‧‧step

3012‧‧‧step

3014‧‧‧step

3105‧‧‧ carrier

3117 (1) ‧‧‧Visual Sign

3117 (2) ‧‧‧Visual Sign

3117 (3) ‧‧‧Visual Sign

3117 (4) ‧‧‧Visual Sign

3117 (5) ‧‧‧Visual Sign

3115B‧‧‧ holding area

3200‧‧‧Process

3202‧‧‧step

3204‧‧‧step

3206‧‧‧step

3208‧‧‧step

3210‧‧‧step

3212‧‧‧step

3300‧‧‧Process

3310‧‧‧step

3320‧‧‧step

3330‧‧‧step

3340‧‧‧step

3342‧‧‧step

3344‧‧‧step

3346‧‧‧step

3350‧‧‧step

3402‧‧‧block

3510‧‧‧candidate blocks

3700‧‧‧ Calibration Process

3710‧‧‧step

3720‧‧‧step

3730‧‧‧step

3740‧‧‧step

3742‧‧‧step

3744‧‧‧ steps

3746‧‧‧step

3750‧‧‧step

4102‧‧‧Test particle

A1‧‧‧Test device

A2‧‧‧test device

A3‧‧‧test device

A4‧‧‧test device

A5‧‧‧Test device

A6‧‧‧test device

A7‧‧‧test device

A8‧‧‧Test device

A9‧‧‧test device

A10‧‧‧test device

H1‧‧‧ focal length parameters

H2‧‧‧ focal length parameters

L1‧‧‧ Arrow

L2‧‧‧Arrow

L3‧‧‧ Arrow

S110‧‧‧step

S120‧‧‧step

S130‧‧‧step

S140‧‧‧step

FIG. 1A is an exploded view of a test device with a zoom function according to a specific example of the present invention.

FIG. 1B is an assembly view of the test device of FIG. 1A.

FIG. 2A is a cross-sectional view of the test device of FIG. 1A.

FIG. 2B is a cross-sectional view of another specific example of the test device.

FIG. 3 is a flowchart of testing of a testing device according to a specific example of the present invention.

FIG. 4 is a cross-sectional view of a test device having a magnifying function according to another embodiment of the present invention.

FIG. 5 is a cross-sectional view of a test device having a magnifying function according to another embodiment of the present invention.

FIG. 6 is a schematic diagram of the test device of FIG. 5 in use.

FIG. 7 is a schematic diagram of a test device with an amplification function according to another embodiment of the present invention.

FIG. 8 is a schematic diagram of a test device with an amplification function according to another embodiment of the present invention.

FIG. 9 is a schematic diagram of a test device with an amplification function according to another embodiment of the present invention.

FIG. 10 is a schematic diagram of a test device with an amplification function according to another embodiment of the present invention.

FIG. 11 to FIG. 13 are views of a test device with a magnifying function according to another three specific examples of the present invention. 14A is a schematic diagram of a test strip inserted into a meter device according to another embodiment of the present invention.

FIG. 14B is a schematic diagram of components of a meter device according to another embodiment of the present invention.

FIG. 15A shows a sample processing procedure of a semen test by a device such as a meter device or a smart communication device.

FIG. 15B shows a sample step 1515 of the processing procedure shown in FIG. 15A.

FIG. 15C shows a sample step 1520 of the processing procedure shown in FIG. 15A.

FIG. 15D shows a sample step 1530 of the processing procedure shown in FIG. 15A.

FIG. 15E shows a sample step 1550 of the processing procedure shown in FIG. 15A.

Fig. 15F shows a sample step 1555 of the processing procedure shown in Fig. 15A.

FIG. 16 shows a sample processing program for determining sperm concentration.

Figure 17 shows sample sperm and sample sperm trajectories.

FIG. 18 shows a sample processing program for determining sperm trajectory and motility.

FIG. 19 is a schematic diagram of a test apparatus including a collection bottle.

FIG. 20 is a schematic diagram of a test apparatus excluding a collection bottle.

21A, 21B, and 21C are schematic cross-sectional views of various specific examples of the test device.

22 is a schematic cross-sectional view of a test device of a test strip device having two sample holding regions.

FIG. 23 is a schematic diagram of components of a test device having an auto-focus function.

FIG. 24 is a schematic diagram of components of another test device having an auto-focus function.

25A and 25B are schematic cross-sectional views of a testing device including a switch and a motor.

26A and 26B are schematic cross-sectional views of a testing device including a flexible element.

FIG. 27 is a flowchart of a processing procedure for analyzing a semen sample of a male client or patient.

FIG. 28 is a flowchart of a processing procedure for analyzing LH or HCG of a female client or patient.

FIG. 29 shows an example of a carrier that may be suitable for a test device having a multi-camera arrangement, such as the test device shown in FIG. 22.

FIG. 30 is a flowchart of a processing procedure for analyzing fertility of both male and female subjects using the test device disclosed herein.

FIG. 31 shows an additional example with a visual cue (e.g., in or near a holding area) that the carrier can be used for an analysis process performed using a control test device.

FIG. 32 is a flowchart of an additional example of a processing program that can be implemented by the disclosed testing device to adaptively execute an analysis processing program based on visual cues.

FIG. 33 is an example flowchart of a processing procedure that can be implemented by the disclosed test device.

FIG. 34 is an example image in which the holding area is divided into many blocks.

FIG. 35 is a diagram illustrating an example of a selection processing procedure of a candidate block.

FIG. 36 is an example image illustrating an image processing program (for example, bipolarization) and a result after the cell number determination.

FIG. 37 is a flowchart of an example calibration procedure that can be implemented by the disclosed testing device.

Figure 38 The test carrier carries an example image of a visual cue and / or image pattern that can be used to correct or validate the test device.

FIG. 39 is an example image of the visual cue in FIG. 38 captured by the disclosed test device.

40A and 40B illustrate different image qualities of different blocks in the captured image of FIG. 39.

FIG. 41 is an example image of a test sample carrying a test sample that can be used to calibrate or validate the test device.

42A and 42B illustrate different image qualities of different blocks in the captured image of FIG. 41.

no

Claims (52)

A device for testing a biological sample, the device comprising: A receiving mechanism for receiving a carrier, wherein the carrier includes a holding area, wherein the holding area carries the biological sample or has been exposed to the biological sample; A camera module configured to capture a set image of the holding area; and A processor configured to use the camera module to (1) identify a visual cue on the carrier from the captured set image of the holding area, and (2) Selectively performing a set of analysis processing procedures on the captured set images based on a result of the visual prompting of the recognition; The set of analysis processing procedures includes: Segmenting the captured set images into a plurality of blocks; Selecting a plurality of candidate blocks from the plurality of blocks for analysis, The selection of the candidate block is based on (1) the degree of focus of the block, and (2) the normality of the block, And by analyzing the plurality of selected candidate blocks, one or more characteristics of the biological sample are determined. The device according to claim 1, further comprising a casing, the casing including an opening; The receiving mechanism receives the inserted carrier through the opening; The collection image is one or more images; The processor is carried on a circuit board; The visual cue is located in or near a holding area on the carrier; Wherein the processor is further configured to determine a final result regarding the biological sample based on the results of the set of analysis processing programs after the set of analysis processing programs are executed; The receiving mechanism, the camera module, and the circuit board are packaged in the casing. The device of claim 1 or 2, wherein the processor is further configured to determine which one of the captured images of the holding area is based on a shape and / or a position of the visual cue. The group analysis handler will be executed. The device according to claim 1 or 2, wherein the processor executes the set of analysis processing programs on the captured image only after the visual cue is recognized. The device according to claim 4, wherein the visual cue is recognized in a predetermined shape and / or a predetermined position. The device according to claim 1 or 2, wherein the visual cue is a size that is not perceived by humans. The device according to claim 6, wherein the size of the visual cue is recognized by the camera module after being enlarged through a micro lens. The device according to claim 1 or 2, wherein said visual cue comprises a predetermined configuration of a plurality of visual signs. The device according to claim 2, wherein the camera module includes a first camera module and a second camera module, and the first camera module and the second camera module are packaged in the housing, The holding area includes an adjacent first holding area and a second holding area; and the processor is further configured to use the first camera module to identify the first holding area on the carrier. And using the second camera module to identify the visual cue on the carrier from the second holding area, wherein the visual cue is a size that is not perceived by humans. The apparatus of claim 9, wherein the processor is further configured to execute a first set of analysis processing programs on the captured images of the first holding area. The device of claim 10, wherein the processor is further configured to determine, based on the shape of the identified first holding area, which set of analysis processing programs to perform on the captured image of the first holding area. The device of claim 9, wherein the processor is configured to respond to the identified shape as a first shape to identify the based on the captured image of the first holding area The acidity of a biological sample. The device according to claim 12, wherein the identification of the acidity is based on a color shown in the first holding area. The device of claim 9, wherein the processor is configured to respond to the identified shape as a second shape to identify the based on the captured image of the first holding area A hormone level in a biological sample. The device according to claim 14, wherein the identified hormone is based on a color shown in the first holding area. The device according to claim 9, wherein the first camera module includes a non-micro lens, and wherein the second camera module includes a micro lens. The device of claim 9, wherein the processor is configured to determine a cell number of the biological sample in response to the identified shape being a first shape. The device according to claim 17, wherein the determination of the number of cells of the biological sample is performed using the second camera module. The device according to claim 2, further comprising: a display packaged in the housing, wherein the processor is configured to display the final result of the determination on the display after obtaining the final result. . The device of claim 1 or 2, wherein the processor is further configured to determine a biochemical characteristic of the biological sample based on one or more images of the holding area. The device according to claim 1, wherein the set of analysis processing programs further comprises: Comparing the focus degree of the block with a focus degree threshold, Among them, the candidate block is selected only after the focus degree of the block satisfies the focus degree threshold. The device according to claim 1, wherein the set of analysis processing programs further comprises: A degree of focus is determined for each of the plurality of blocks based on one or more focal length measurement functions. The device according to claim 22, wherein the one or more focal length measurement functions include one or more of a variation type, a difference coefficient sum type, a Laplacian energy image type, or a side gradient intensity maximization type . The device according to claim 1, wherein the set of analysis processing programs further comprises: Determine the normality of the block by statistically comparing one or more characteristics of the block and the plurality of blocks, The block is selected as a candidate block only after the block meets a normality requirement. The device according to claim 24, wherein one or more characteristics of the block include a cell number of the block, and wherein the normality requirement is a preset value of a standard deviation of the plurality of blocks . The device according to claim 25, wherein the preset standard deviation value is two standard deviations. The apparatus according to claim 1, wherein the set of analysis processing programs further includes: for each block that satisfies a focus degree threshold, an image processing program is executed to determine the number of cells. The apparatus according to claim 27, wherein the image processing program includes adaptively limiting binarization. The apparatus according to claim 27, wherein the set of analysis processing procedures further includes: (1) an average of the number of cells and (2) a standard deviation of the number of cells are calculated from all blocks satisfying the focus degree threshold. The apparatus according to claim 1, wherein the selection of the candidate block is further based on a total cell number, which controls a number of biological samples to be analyzed. The device according to claim 1, wherein the set of analysis processing programs further comprises: maintaining a total cell number; and summing a corresponding cell number of each selected block as the candidate block to the total cell number, wherein the candidate The selection of blocks is completed when the total number of cells reaches a target number of cells to be analyzed. The apparatus according to claim 31, wherein the target number of the cells to be analyzed is 200. The device according to claim 1, wherein the selection of the candidate block is performed randomly to satisfy a focus degree threshold and a normality requirement, which is until a total number of cells reaches a cell to be analyzed Number of targets. The device according to claim 1, wherein the shape of the plurality of blocks is a polygon. The device according to claim 1, wherein the shape of the plurality of blocks is a triangle, a square, a pentagon or a hexagon, and one side of the plurality of blocks is at least 0.05 mm. The device according to claim 1, wherein the biological sample is semen. The device of claim 1, wherein the one or more characteristics of the biological sample include one or more: cell number, motility, or morphology. The device according to claim 1, further comprising a casing, wherein the receiving mechanism, the camera module, and the processor are packaged in the casing. The device according to claim 2 or 38, wherein an external dimension of the casing is less than 27000 cm3. According to the device of claim 1, the processor executes the analysis processing program after executing a correction program for each of the divided plural blocks. The apparatus according to claim 40, wherein the correction procedure is that the processor compares the captured set image with one or more desired results to determine whether the captured set image satisfies A minimum standard. The device according to claim 41, wherein the desired result is one or more images pre-installed in a memory of the processor. The device according to claim 42, wherein the one or more images in the memory are visual patterns. The device of claim 41, wherein the comparing comprises comparing and viewing an image quality parameter. The device according to claim 44, wherein the image quality parameters include: color distortion, pattern distortion, or sharpness defects. The apparatus according to claim 40, after the processor recognizes the visual cue on the carrier, performs the calibration procedure. The device according to claim 40, wherein the holding area of the carrier carries a test sample containing a plurality of test particles, and the processor performs the calibration procedure after identifying the test particles in the test sample. A device for testing a biological sample, the device comprising: A casing comprising an opening; A receiving mechanism for receiving a carrier, the receiving mechanism receiving the inserted carrier through the opening; wherein the carrier includes a holding area, wherein the holding area carries the biological sample or has been exposed to the carrier Biological sample A camera module configured to capture one or more images of the holding area; and A circuit board carrying a processor configured to use the camera module to (1) identify the holding area on the carrier from the captured image of the holding area A visual cue at or near, and (2) selectively performing a set of analysis processing procedures on the captured image of the holding area based on a result of the visual cue and the identification; The processor is further configured to determine a final result on the biological sample based on a result of the analysis processing program after the analysis processing program is executed; The receiving mechanism, the camera module, and the circuit board are packaged in the casing. The device according to claim 48, wherein the visual cue is a size that is not perceived by humans, and the size is recognized by the camera module through a micro lens. The device according to claim 48, wherein an outer dimension of the casing is less than 27000 cm3. The device according to claim 48, wherein the camera module includes a first camera module and a second camera module, and the first camera module and the second camera module are packaged in the housing, And the processor is further configured to use the first camera module to identify a shape of a first holding area on the carrier, and use the second camera module to identify the visual cue, wherein The visual cue is a dimension that is not perceived by humans. A method for determining the characteristics of a biological sample, including: Using a device as described in any one of claims 1 to 51, Operating a processor to use a camera module to (1) identify a visual cue on the carrier from the captured set image of the holding area, and (2) based on the visual cue the identified As a result, a set of analysis processing programs are selectively executed on the captured collection images; The set of analysis processing procedures includes: Segmenting the captured set images into a plurality of blocks; Selecting a plurality of candidate blocks from the plurality of blocks for analysis, The selection of the candidate block is based on (1) the degree of focus of the block, and (2) the normality of the block, And one or more characteristics of the biological sample are determined by the plurality of selected candidate blocks.