CN117347350B - An improved device for chemiluminescent whole blood detection - Google Patents
An improved device for chemiluminescent whole blood detection Download PDFInfo
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- CN117347350B CN117347350B CN202311461085.9A CN202311461085A CN117347350B CN 117347350 B CN117347350 B CN 117347350B CN 202311461085 A CN202311461085 A CN 202311461085A CN 117347350 B CN117347350 B CN 117347350B
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Abstract
本发明提供一种改进的应用于化学发光全血检测的装置，包括主体单元、以及设于主体单元上的活动单元，通过活动单元与主体单元选择性贯通以便于活动单元上的反应工作和测试工作；适配化学发光测试仪用的试剂检测卡条装置，包括加样孔、反应孔、设于加样孔和反应孔之间以连通加样孔和反应孔的连接通道、活动部件以及活动部件限位槽，加样孔内设置有可控样本隔垫，可控样本隔垫设置为多孔疏水隔垫，多孔疏水隔垫能够克服样本重力，避免待测样本自然流进反应孔内；活动部件包括活动部件试剂槽，反应孔与活动部件试剂槽相通，活动部件试剂槽内置放有试剂，待测样本通过连接通道进入反应孔与试剂混合进行反应。
The invention provides an improved device for chemiluminescent whole blood detection, comprising a main unit and an active unit arranged on the main unit, the active unit and the main unit are selectively connected to facilitate reaction work and test work on the active unit; a reagent detection card strip device adapted for a chemiluminescent tester comprises a sample addition hole, a reaction hole, a connecting channel arranged between the sample addition hole and the reaction hole to connect the sample addition hole and the reaction hole, a movable component and a movable component limiting groove, a controllable sample spacer is arranged in the sample addition hole, the controllable sample spacer is arranged as a porous hydrophobic spacer, the porous hydrophobic spacer can overcome the sample gravity and prevent the sample to be tested from naturally flowing into the reaction hole; the movable component comprises a movable component reagent tank, the reaction hole is connected to the movable component reagent tank, a reagent is placed in the movable component reagent tank, and the sample to be tested enters the reaction hole through the connecting channel and is mixed with the reagent to react.
Description
Technical Field
The invention relates to the technical field of biochemical detection, in particular to an improved device applied to chemiluminescent whole blood detection.
Background
The photo-excitation chemiluminescence (LIGHT INITIATED Chemiluminescent Assay) is a homogeneous phase immunity detection technology, and the photo-excitation chemiluminescence technology has the characteristics of high sensitivity, wide detection range, low noise background, no-wash operation, time saving, no influence of PH value, ion intensity and temperature and the like, and can be used in various fields of detection of clinical immunity, screening of new drugs, basic research of life science and the like. The most sources of samples for POCT detection are whole blood samples, and since the excitation light of light excitation chemiluminescence adopts 680nm red light, red cells in the whole blood samples have obvious scattering effect on the excitation light, and the accuracy of the test is affected, so the POCT test of the whole blood samples by using light excitation chemistry has the limitation.
Disclosure of Invention
The present invention provides an improved device for chemiluminescent whole blood detection that effectively solves the above-described problems.
The invention is realized in the following way:
an improved device for use in chemiluminescent whole blood detection comprising:
The main body unit comprises a sample adding hole, a reaction hole and a connecting channel for communicating the sample adding hole and the reaction hole, wherein a controllable sample spacer is arranged in the sample adding hole; and
The movable unit comprises at least one reaction position and at least one test position, wherein the reaction position and the test position are selectively communicated with the reaction hole, and reagents can be placed in the reaction position and the test position.
As a further improvement, the controllable sample spacer is provided as a porous hydrophobic structure.
As a further improvement, the controllable sample spacer is made of a hydrophobic material or a material with a surface subjected to hydrophobic treatment.
As a further improvement, a negative pressure suction nozzle is arranged above the reaction hole.
As a further improvement, the movable unit further comprises a movable component rod and a movable component limiting bolt, wherein the reaction position and the test position are both arranged on the movable component rod, the movable component rod enables the reaction hole to be communicated with the reaction position or the test position, and the movable component rod is limited to move through the movable component limiting bolt.
As a further improvement, the reaction position and the test position are both arranged in a groove-like structure, the reaction position is arranged as a first movable part reagent groove, and the test position is arranged as a second movable part reagent groove.
As a further improvement, the main body unit is provided with a first movable part limiting groove and a second movable part limiting groove which correspond to the reaction position and the test position respectively, and the movable part limiting bolt is movably accommodated in the first movable part limiting groove or the second movable part limiting groove.
As a further improvement, the reaction holes are arranged in a cylindrical structure or a cuboid structure; the movable part rod is arranged in a cylindrical structure shape and/or a cuboid structure shape.
As a further improvement, the volume of liquid contained in the reaction well is larger than the volume in the first movable part reagent tank or the second movable part reagent tank.
As a further improvement, the movable part rod and the movable part limiting bolt are made of plastic materials.
The beneficial effects of the invention are as follows:
The device and the using flow can remove red blood cells in a whole blood sample, eliminate the influence of the red blood cells on a test result, and simultaneously can effectively perform step-by-step control, so that the test result is more accurate and better, the device does not need to give extra reaction time for independently settling the red blood cells, thereby shortening the reaction time and effectively playing the advantages of photo-excitation chemiluminescence for POCT project detection.
The red blood cell separation function in the whole blood sample can be achieved without the need of blood filtering membrane medium and cleaning: most luminescent reagent test samples currently on the market are plasma or serum samples, but not whole blood samples. Application of chemiluminescent methods to POCT directions where whole blood samples need to be detected is limited. The invention discloses a separation mode for separating red blood cells, which is completed by utilizing the immune agglutination precipitation phenomenon of red blood cells by red blood cell antibodies and adopting a specific structural design and flow. After the whole blood sample reacts with the reagent in the reaction hole, the red blood cell antibody can rapidly coagulate red blood cells, the red blood cells can be rapidly precipitated under the action of gravity, and the precipitated red blood cells are pushed into the closed cavity through a specific structural design, so that the influence of the red blood cell scattering effect on the project is eliminated. The device and the testing flow of the invention avoid the conventional adoption of the blood filtering film to separate the red blood cells in the whole blood sample testing process, thereby avoiding the adsorption effect of the blood filtering film on the object to be tested and providing a good foundation for more accurate POCT quantitative detection.
Shortening the reaction time function: most of the existing methods for treating whole blood in the market adopt centrifugal separation, filtration separation or other erythrocyte sedimentation methods, which require independent erythrocyte sedimentation reaction time, and the device and the process can be directly carried out together with reagent reaction without additionally giving independent erythrocyte sedimentation reaction time, thereby shortening the reaction time and providing a good foundation for faster POCT quantitative detection.
Protection of the device structure against test dry reagents: the photo-activated chemiluminescent test reagent component mainly comprises a labeled donor microsphere, a labeled acceptor microsphere, labeled biotin and the like. The test reagent preferably used in the invention is in the form of dry reagent of each component, namely a dry reagent of the labeled receptor microsphere, a dry reagent of the labeled receptor microsphere and a dry reagent of the labeled biotin. Because the labeled donor microspheres are relatively sensitive to ambient light, the direct exposure of the labeled donor microspheres to ambient light during use should be avoided as much as possible, which affects the test results. The device can effectively avoid the direct exposure of the marked donor microsphere to the ambient light. The device can store the components of the marked donor microspheres in the bottom of the reaction hole, and the ambient light can not directly contact the marked donor microspheres before use and in the transportation process, so that the influence of the ambient light on the donor microspheres is minimized. This structure protects the mode of the donor microsphere.
Realizing an immune step method detection structure: in the immunological test method, the small molecule items are detected by a two-step competition method. The device and the test flow of the invention can also be used for testing small molecule antigens by a two-step incubation method. The method comprises the steps of subpackaging the labeled antibody freeze-dried pellets into a first movable part reagent tank, subpackaging other freeze-dried pellets into a second movable part reagent tank, adding a sample to be tested into a sample adding hole, suction-filtering the sample adding hole, then entering the first movable part reagent tank, dissolving the labeled antibody reagent, performing a first-step reaction, and after a period of time, pulling a bottom glue tank, so that liquid enters the second movable part reagent tank to dissolve other components for further performing a second-step reaction and detecting. The two-step method can be applied to the process of testing the small molecule antigen, and the whole flow is completed by a testing instrument, so that the error can be effectively reduced, the detection precision can be improved, and the detection time can be shortened. The structure can realize a mode of step-by-step detection.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings that are needed in the embodiments will be briefly described below, it being understood that the following drawings only illustrate some examples of the present invention and therefore should not be considered as limiting the scope, and other related drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.
FIG. 1 is a schematic diagram of a test card strip according to an embodiment of the invention.
Fig. 2 is a schematic structural view of an embodiment of the present invention.
Fig. 3 is a schematic structural diagram of a first embodiment of the present invention.
Fig. 4 is a schematic structural diagram of a first embodiment of the present invention.
Fig. 5 is a schematic diagram of a second embodiment of the present invention.
Fig. 6 is a schematic diagram of a second embodiment of the present invention.
Fig. 7 is a schematic diagram of a third embodiment of the present invention.
Fig. 8 is a schematic diagram of a third embodiment of the present invention.
In the figure:
000-whole blood sample to be tested; 001-reaction supernatant; 002-agglutinating red blood cells;
110-a body unit; 112-a movable part limiter; 113-a first movable part limit groove; 114-a second movable part limit groove;
120-moving part bar; 121-a first movable part reagent tank; 122-a second movable part reagent tank;
130-controllable sample spacers; 140-sample-adding holes; 150-connecting channels; 160-reaction wells; 170-a movable part limit bolt; 180-negative pressure suction nozzle;
221. 222, 211, 212, 213-dry reagent.
Detailed Description
For the purpose of making the objects, technical solutions and advantages of the embodiments of the present invention more apparent, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention, and it is apparent that the described embodiments are some embodiments of the present invention, but not all embodiments. All other embodiments, based on the embodiments of the invention, which are apparent to those of ordinary skill in the art without inventive faculty, are intended to be within the scope of the invention. Thus, the following detailed description of the embodiments of the invention, as presented in the figures, is not intended to limit the scope of the invention, as claimed, but is merely representative of selected embodiments of the invention. All other embodiments, based on the embodiments of the invention, which are apparent to those of ordinary skill in the art without inventive faculty, are intended to be within the scope of the invention.
In the description of the present invention, the terms "first," "second," and the like are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include one or more such feature. In the description of the present invention, the meaning of "a plurality" is two or more, unless explicitly defined otherwise.
Referring to fig. 1, a reagent detection strip device for adapting to a chemiluminescent tester comprises a sample adding hole 140, a reaction hole 160, a connecting channel 150, a movable part and a movable part limiting groove, wherein the connecting channel 150, the movable part and the movable part limiting groove are arranged between the sample adding hole 140 and the reaction hole 160 so as to communicate the sample adding hole 140 with the reaction hole 160, a controllable sample spacer 130 is arranged in the sample adding hole 140, the controllable sample spacer 130 is a porous hydrophobic spacer, the porous hydrophobic spacer can overcome sample gravity, and a sample to be tested is prevented from naturally flowing into the reaction hole 160. The movable part comprises a movable part reagent groove, the reaction hole 160 is communicated with the movable part reagent groove, a reagent is placed in the movable part reagent groove, and a sample to be tested enters the reaction hole 160 through the connecting channel 150 to be mixed with the reagent for reaction. The movable part further comprises a movable part rod 120 and a movable part limiting bolt 170, two movable part reagent grooves are formed in the movable part rod 120, and the movable part reagent grooves can store non-liquid reagents. The two movable part reagent tanks are a first movable part reagent tank 121 and a second movable part reagent tank 122, respectively.
In the initial position, the first movable part reagent groove 121 is communicated with the reaction hole 160, the sample to be tested enters the reaction hole 160 and is mixed with the reagent in the first movable part reagent groove 121, after the mixture is uniform or the reaction is complete, the movable part rod 120 is moved to enable the second movable part reagent groove 122 to be communicated with the reaction hole 160, and the reagent in the second movable part reagent groove 122 can participate in the reaction to enter the test state. The initial position and the test position of the movable part are limited by the limit groove of the movable part. That is, the reagent test strip device can realize POCT whole blood test by combining red blood cell antibody immune agglutination reaction without using other red blood cell separation devices.
Referring to fig. 2, an improved device for chemiluminescent whole blood test comprises a main unit 110 and a movable unit arranged on the main unit 110, wherein the movable unit is selectively communicated with the main unit 110 to facilitate reaction work and test work on the movable unit.
The main body unit 110 includes a loading hole 140, a reaction hole 160, a connection channel 150 communicating the loading hole 140 and the reaction hole 160, and a movable member stopper 112, and the movable unit includes at least one reaction position and at least one test position, where the reaction position and the test position are selectively communicated with the reaction hole 160, and the position where the reaction hole 160 is connected through is defined by the movable member stopper 112. Reagents are placed in the reaction position and the test position.
In a normal state, the reaction hole 160 is correspondingly communicated with the reaction position, the sample to be measured is added from the sample adding hole 140, flows into the reaction hole 160 through the connecting channel 150, and flows from the reaction hole 160 to the reaction position. However, in order to prevent the sample to be tested from flowing from the loading hole 140 to the reaction hole 160 when the reaction position is not ready, a controllable sample spacer 130 is disposed in the loading hole 140, and the controllable sample spacer 130 can support the sample to be tested so that the sample to be tested cannot automatically flow to the reaction hole 160.
The controllable sample spacer 130 is configured as a porous hydrophobic structure, and the controllable sample spacer 130 is disposed on a cross section of the sample application hole 140. The porous hydrophobic structure of the controllable sample spacer 130 can overcome the gravity characteristic of the sample to be tested, and prevent the sample to be tested from naturally flowing into the reaction hole 160, so that the sample to be tested is controlled by the controllable sample spacer 130. The controllable sample spacer 130 may be made of a hydrophobic material or a material with a surface that is hydrophobic.
And a negative pressure suction nozzle 180 is arranged above the reaction hole 160, when a sample to be tested needs to flow into the reaction hole 160 from the sample adding hole 140, the negative pressure suction nozzle 180 is controlled to form a certain negative pressure in the reaction hole 160, and the negative pressure suction nozzle 180 performs negative pressure suction on the reaction hole 160, so that the sample to be tested flows into the reaction hole 160 from the sample adding hole 140 through the porous hydrophobic structure through the connecting channel 150, flows into the reaction position and is mixed with the reagent in the reaction position for reaction.
The movable unit comprises a movable component rod 120 and a movable component limit bolt 170, and the reaction position and the test position are both arranged on the movable component rod 120; the reaction position and the test position are both set to be in a groove-shaped structure, the reaction position is set to be a first movable part reagent groove 121, and the test position is set to be a second movable part reagent groove 122; the movable part limiting grooves include a first movable part limiting groove 113 corresponding to the first movable part reagent groove 121 and a second movable part limiting groove 114 corresponding to the second movable part reagent groove 122. When the movable member bar 120 is moved, the reaction hole 160 is communicated with the first movable member reagent groove 121, the movable member stopper 170 is accommodated in the first movable member stopper groove 113, or the reaction hole 160 is communicated with the second movable member reagent groove 122, the movable member stopper 170 is accommodated in the second movable stopper groove, and the movable member stopper 170 restricts the movement of the movable member bar 120 to prevent the first movable member reagent groove 121 from being displaced during the reaction or the second movable member reagent groove 122 from being displaced during the test, thereby failing the test. The movable member stopper 112 has a deformation structure to form a certain elastic deformation capability when the movable member lever 120 moves from the reaction position to the test position, so that the movable member lever 120 can maintain a position during transportation of the test card.
The first movable part reagent tank 121 and the second movable part reagent tank store reagents which are set as liquid or non-liquid reagents. In the initial state, the first movable part reagent groove 121 is communicated with the reaction hole 160, the sample to be tested can be mixed with the reagent in the first movable part reagent groove 121 after entering the reaction hole 160, after being uniformly mixed or completely reacted, the movable part rod 120 is moved by the action of external force, so that the second movable part reagent groove 122 is communicated with the reaction hole 160, and the reagent in the second movable part reagent groove 122 can participate in the reaction to finally enter the test state.
In one embodiment, the reagent is a solid dry reagent. After the sample to be tested flows through the connecting channel 150 from the sample adding hole 140 and enters the reaction hole 160, the solid dry reagent can be redissolved for reaction.
The volume of the liquid entering the reaction hole 160 is larger than the volume of the first movable part reagent tank 121 or the second movable part reagent tank 122, and thus, the sample to be measured has a volume requirement. After the movable member bar 120 moves from the reaction position to the test position, the mixed reaction solution in the first movable member reagent tank 121 is enclosed in the tank-like structure thereof. When the movable member bar 120 is at the testing position, the mixed reaction liquid in the first movable member reagent tank 121 is in an ineffective volume, and the ineffective volume needs to be subtracted from the liquid of the sample to be tested entering the reaction hole 160.
The reaction holes 160 are provided in a cylindrical structure or a rectangular parallelepiped structure. In this embodiment, the reaction hole 160 is configured as a cylindrical structure, and the bottom surfaces of the first movable component reagent tank 121 and the second movable component reagent tank 122 are configured as concave hemispherical arc structures, which is beneficial to mixing of reagents and collection of test light signals.
The movable member bar 120 is provided in a cylindrical structure shape, which facilitates sealing, and/or a rectangular structure shape, which facilitates preventing the movable member bar 120 from rotating. In this embodiment, the cross section of the movable component rod 120 near the side of the reaction hole 160 is semicircular, the cross section of the movable component rod 120 far away from the side of the reaction hole 160 is square, that is, the side of the movable component rod 120 near the side of the reaction hole 160 is in a cylindrical structure, and the side of the movable component rod 120 far away from the side of the reaction hole 160 is in a rectangular structure, so that the movable component rod 120 can maintain a certain tightness and prevent the movable component rod 120 from rotating, thereby avoiding dislocation of the reaction hole and the movable component reagent tank.
The movable member bar 120 is made of a plastic material, so that the movable member bar 120 has a certain elastic deformation characteristic. In addition, the movable part limiting bolt 170 is made of plastic material and has a certain deformability, so that the movable part limiting bolt 170 and the movable part rod 120 form a tight combination, and the movable part limiting bolt 170 and the movable part rod 120 are not separated.
Embodiment one:
As the red blood cells have obvious influence on the photoexcitation test result, the red blood cells in the sample to be tested are required to be separated in the test process. However, in general, separation of red blood cells requires the use of centrifugation equipment or filter media. The application of centrifugal equipment does not accord with the application scene of chemiluminescent POCT, and the application of a filter medium such as a blood filter membrane for filtering erythrocytes in a sample cannot exclude the adsorption and filtration influence of the filter medium on substances to be tested, so that the adsorption effect brought by the blood filter membrane is difficult to remove for POCT reagents needing quantitative test results, and the accuracy of quantitative test is influenced. Therefore, the aim of removing the red blood cells is achieved by utilizing the immune agglutination reaction of the red blood cell antibody and the structure of the reagent detection card strip device.
In this embodiment, the sample diluent to be tested contains a red blood cell antibody, which may be a monoclonal antibody, a polyclonal antibody or a mixed antibody. The erythrocyte antibody can perform immune agglutination reaction with erythrocyte, the immune reaction is rapid, and the agglutinated erythrocyte naturally precipitates due to the self gravity, thereby achieving the effect of separating erythrocyte in the sample. The separation of erythrocytes by the agglutination and precipitation of erythrocytes is not limited to the immune response of erythrocyte antibodies, and other reagents capable of rapidly agglutinating and precipitating erythrocytes are also within the scope of the present invention.
In this embodiment, the reagent for reaction is a photoexcitation chemiluminescent test reagent, which may be in liquid or solid form. Preferably, the test reagent is a reagent in solid form, which may also be prepared by freeze-drying a liquid reagent. In this embodiment, the solid form reagent may be a solid combination reagent including a labeled donor microsphere, a biotin-labeled antibody microsphere or biotin-labeled antigen microsphere, and a labeled acceptor microsphere. When the solid form reagent is mixed with a sample to be tested for reaction, the biotin-labeled antibody microspheres and the labeled acceptor microspheres form reaction complexes with the sample to be tested, and the reaction complexes to be tested and the labeled donor microspheres form final reactants which can be detected by the light-activated chemiluminescence equipment.
The sample to be tested may be provided as a plasma sample, a serum sample or a whole blood sample. After the sample to be measured and the sample diluent are mixed and diluted, the diluted sample is added into the sample adding hole 140, the negative pressure suction nozzle 180 sucks the reaction hole 160, so that the diluted sample on the porous hydrophobic structure enters the reaction hole 160, and a reaction reagent is stored in the reaction hole 160, and the diluted sample and the reaction reagent are mixed and reacted.
In this embodiment, the sample to be tested is a whole blood sample 000, and the sample diluent is a whole blood sample 000 diluent. The whole blood sample 000 dilutions contain red blood cell antibodies, and the antibodies may be red blood cell antibodies or polyclonal antibodies. The reaction reagent is configured as a photo-activated chemiluminescent test dry reagent combination comprising labeled donor microspheres, labeled acceptor microspheres, biotin-labeled antibody microspheres. The whole blood sample 000 and the whole blood sample 000 diluent are mixed and diluted and then added into the sample adding hole 140, and the negative pressure suction nozzle 180 sucks the reaction hole 160, so that the diluted sample on the porous hydrophobic structure enters the reaction hole 160 to re-dissolve the dry reagent combination for reaction. In the reaction process of the whole blood sample 000 to be measured in the reaction well 160 with the reaction reagent, since the whole blood sample 000 contains the red blood cell antibody in the diluent, the red blood cells in the whole blood sample 000 and the red blood cell antibody undergo the immune agglutination reaction, and the agglutinated red blood cells 002 quickly settle to the bottom of the first movable member reagent tank 121 under the action of gravity, and the reaction supernatant 001 is separated from the agglutinated red blood cells 002, as shown in fig. 3. After the sample to be tested and the reaction reagent complete the reaction, the movable component rod 120 moves from the reaction position to the testing position under the action of external force, and the second movable component reagent groove 122 is communicated with the reaction hole 160 and performs optical signal collection, as shown in fig. 4.
Embodiment two:
since the labeled donor microsphere dry reagents are relatively sensitive to ambient light, exposure of the test reagents to ambient light should be avoided during the test. The reagent test strip device provides better protection for the test dry reagents 221, 222, 211, 212, 213, and the second movable member reagent tank 122 can store labeled donor microsphere dry reagents that are sensitive to ambient light. During the use test, the sample addition well 140 and the reaction well 160 are directly exposed to the ambient light, and the ambient light does not contact the dry reagent of the labeled donor microsphere, so that the influence of the ambient light on the labeled donor microsphere during the use process can be ensured to be minimized.
Referring to fig. 5, the first movable member reagent tank 121 and the second movable member reagent tank 122 each hold a reaction reagent therein. The sample to be tested is a whole blood sample 000, and the sample diluent is a whole blood sample 000 diluent. The whole blood sample 000 dilutions contain red blood cell antibodies, and the antibodies may be red blood cell antibodies or polyclonal antibodies. The reaction reagent is configured as a photo-activated chemiluminescent test dry reagent combination comprising labeled donor microspheres, labeled acceptor microspheres, biotin-labeled antibody microspheres. In this embodiment, since the photo-activated chemiluminescent labeled donor microsphere reagent is susceptible to the influence of the ambient light with a specific wavelength, the susceptible labeled donor microsphere reagent is pre-stored in the second movable component reagent tank 122, other labeled acceptor microsphere and biotin-labeled antibody microsphere components are placed in the first movable component reagent tank 121, the whole blood sample 000 to be tested is mixed with the sample diluent on the controllable sample spacer 130, and the mixture is sucked under negative pressure by the negative pressure suction nozzle 180, and then enters the reaction hole 160 and pre-reacts with the components of the reaction reagent in the first movable component reagent tank 121. While the whole blood sample 000 to be measured reacts with the reagent, the red blood cells in the sample react with the red blood cell antibodies in the sample diluent to generate immune agglutination reaction, and the agglutinated red blood cells are rapidly precipitated into the first movable part reagent tank 121 under the action of gravity, as shown in fig. 6. After the erythrocyte precipitation is completed, the movable part rod 120 moves from the reaction position to the test position under the action of external force, the labeled donor microsphere reagent pre-stored in the second movable part reagent tank 122 and the reaction mixed liquid from which the erythrocyte is removed continue to react, and the reaction light signal can be collected after the reaction is completed. In this embodiment, the labeling donor microsphere reagent is pre-stored, so that the influence of the environment on the labeling donor microsphere can be reduced as much as possible.
Embodiment III:
In order to meet the requirements of the small molecule antigen project, a two-step competition method is required for testing. The sample to be tested is a whole blood sample 000, and the sample diluent is a whole blood sample 000 diluent. The whole blood sample 000 dilutions contain red blood cell antibodies, and the antibodies may be red blood cell antibodies or polyclonal antibodies. The reaction reagent is configured as a photo-activated chemiluminescent test dry reagent combination comprising labeled donor microspheres, labeled acceptor microspheres, biotin-labeled antibody microspheres. Referring to fig. 7, the second movable member reagent tank 122 is provided with a labeled donor microsphere reagent and a biotin labeled antigen microsphere component in advance, the first movable member reagent tank 121 is provided with a labeled acceptor microsphere reagent, and the whole blood sample 000 to be measured and the sample diluent are introduced into the reaction well 160 after being mixed and pre-reacted with the labeled acceptor microsphere reagent component in the first movable member reagent tank 121. The red blood cells in the sample and the red blood cell antibodies in the sample dilution generate immune agglutination and precipitate to the bottom of the first movable part reagent tank 121. Referring to fig. 8, when the agglutination and precipitation of the erythrocytes is completed, the movable member bar 120 moves from the reaction position to the test position under the action of an external force, and the labeled donor microsphere reagent and the biotin-labeled antigen microsphere, which are pre-stored in the second movable member reagent tank 122, continue to react competitively with the reaction mixture from which the erythrocytes are removed, and after the reaction is completed, the reaction light signal can be collected.
The above description is only of the preferred embodiments of the present invention and is not intended to limit the present invention, and various modifications and variations may be made to the present invention by those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (7)
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| US6171870B1 (en) * | 1998-08-06 | 2001-01-09 | Spectral Diagnostics, Inc. | Analytical test device and method for use in medical diagnoses |
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| JP2006058280A (en) * | 2004-03-16 | 2006-03-02 | Fuji Photo Film Co Ltd | Assay chip |
| JP4478776B2 (en) * | 2004-08-09 | 2010-06-09 | 独立行政法人物質・材料研究機構 | Blood analyzer and blood analysis method |
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| WO2013165420A1 (en) * | 2012-05-03 | 2013-11-07 | Qualigen, Inc. | Whole blood analytic device and method therefor |
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Application publication date: 20240105 Assignee: Xiamen Baotai Biotechnology Co.,Ltd. Assignor: Xiamen Baotai Herui Biotechnology Co.,Ltd. Contract record no.: X2025980038798 Denomination of invention: An improved device applied to chemiluminescence whole blood testing Granted publication date: 20240906 License type: Common License Record date: 20251204 |