WO2018137527A1 - 潜血试纸 - Google Patents

潜血试纸 Download PDF

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Publication number
WO2018137527A1
WO2018137527A1 PCT/CN2018/073029 CN2018073029W WO2018137527A1 WO 2018137527 A1 WO2018137527 A1 WO 2018137527A1 CN 2018073029 W CN2018073029 W CN 2018073029W WO 2018137527 A1 WO2018137527 A1 WO 2018137527A1
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WO
WIPO (PCT)
Prior art keywords
layer
fiber
biological sample
occult blood
folding line
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Ceased
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PCT/CN2018/073029
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English (en)
French (fr)
Inventor
吴智良
周文彬
王信尧
吴旻宪
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Individual
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Individual
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Priority to EP18745392.3A priority Critical patent/EP3575780A4/en
Priority to US16/479,777 priority patent/US20210333267A1/en
Publication of WO2018137527A1 publication Critical patent/WO2018137527A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
    • G01N21/78—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a change of colour
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/52—Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/52—Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements
    • G01N33/525—Multi-layer analytical elements
    • G01N33/526—Multi-layer analytical elements the element being adapted for a specific analyte
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/72—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood pigments, e.g. haemoglobin, bilirubin or other porphyrins; involving occult blood
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/90—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving iron binding capacity of blood
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/06—Gastro-intestinal diseases
    • G01N2800/065—Bowel diseases, e.g. Crohn, ulcerative colitis, IBS

Definitions

  • the present invention relates to a occult blood test strip, in particular to the use of a occult blood test strip bent along at least one fold line and folded in half, so that the biological sample contacts the test substance by infiltration and reacts, and identifies whether the biological sample contains occult blood by discoloring the reaction, and A possible method of determining whether or not there is colorectal cancer. It can facilitate the screening of colorectal cancer in the home space, and greatly increase the penetration rate of screening.
  • the principle of chemical method is to use hemoglobin in fecal occult blood: when there is occult blood in the feces, the iron ions in hemoglobin will undergo redox reaction with the added reagent, and the coloring agent is used as the basis for the judgment.
  • the immunoassay and the chemical method are both fecal collection tests, which use latex particles with human heme-targeted antibodies to detect hemoglobin in the feces. When there is occult blood in the feces, the special antibody on the latex particles will bind to the heme.
  • colonoscopy is different from chemical and immunological methods. Colonoscopy is a method of directly examining the wall of the large intestine with an endoscope. The advantage is that when a lesion is found, the surgeon can directly remove the lesion through the colonoscopy. With the benefits of diagnosis and treatment. However, due to its invasive nature, it is estimated that every thousand colonoscopes operated may cause serious complications of one to three large intestine ruptures. In general, chemical screening has several advantages: excellent sensitivity and specificity, low price, non-invasive, and no complications. Therefore, compared with the immunological method and colonoscopy, the chemical method is more suitable as a method for colorectal cancer screening.
  • a novel occult blood test paper in which a occult blood test paper is bent and folded in half along at least one folding line, so that the biological sample is in contact with the test substance by infiltration and reacts, and whether the biological sample contains occult blood by identifying whether the reaction is discolored or not. Therefore, the user can identify the occult blood by wiping and folding, without any pre-treatment or post-treatment of the biological sample, and in particular, does not cause any discomfort to the user, and is quite hygienic, thereby solving the above problems of the prior art.
  • the main object of the present invention is to provide a occult blood test paper comprising a liquid permeable bearing layer, a detecting layer and an outer layer, wherein the liquid permeable bearing layer has water permeability and has an upper surface and a lower surface, and the upper surface is used for carrying a biological sample, such as feces, urine or biological secretions; the detection layer is translucent and water permeable, and has an upper surface and a lower surface, and includes a detection substance uniformly distributed in at least one region of the detection layer; the outer layer has It is impervious to water and light, and is attached to the lower surface of the liquid permeable bearing layer and the lower surface of the detecting layer. Further, the side of the liquid-permeable bearing layer is connected to the corresponding side of the detecting layer, and the upper surface of the joint of the liquid-permeable bearing layer and the detecting layer is formed with at least one folding line.
  • the biological sample is infiltrated into the detection layer after being bent, and reacted with the detection substance to react, and whether the biological sample contains occult blood can be identified by whether or not the reaction is discolored.
  • the liquid permeable bearing layer is composed of at least one of chemical fiber, vegetable fiber, animal fiber and mineral fiber
  • the detecting layer is made of plant fiber, nitrocellulose, polyethylene, polypropylene, cellulose acetate, It is composed of at least one of polyvinyl chloride and polyvinylidene chloride.
  • the chemical fiber comprises at least one of polyester, nylon, spandex, acrylic, acetate fiber, the animal fiber comprising at least one of animal hair, silk fiber and spider fiber, the mineral fiber comprising asbestos .
  • Another object of the present invention is to provide a occult blood test paper comprising a liquid-permeable bearing layer, a detecting layer and an outer surface layer which are sequentially stacked from top to bottom, wherein the liquid-permeable bearing layer has water permeability and has an upper surface and a lower surface, and an upper surface of the liquid permeable bearing layer is used to carry the biological sample, and at least one folding line is provided at the middle of the upper surface for bending; the detecting layer is translucent and water permeable, and has a surface and a lower surface, the upper surface of the detecting layer is attached to the lower surface of the liquid permeable bearing layer, and the detecting layer is provided with at least one cavity, each cavity having at least two slots for accommodating the detecting substance, At least two slots are separated by a separating film, the separating film is vertically aligned with the folding line, and the detecting substance comprises a coloring substance and a redox substance, respectively accommodated in different cells; and the outer layer is water permeable And light transmit
  • the redox species has a function of decomposing and releasing free electrons by redox reaction of iron, and the coloring matter has a function of receiving free electrons released by the redox species and causing a change in the color of the coloring matter.
  • the biological sample is sandwiched by the upper surface of the liquid-permeable bearing layer and penetrated into the detection layer after the folding line is bent.
  • the separation film breaks when the folding line is bent to release the coloring matter and the redox substance contained in the at least two grooves, and reacts with the biological sample to react, thereby identifying whether the biological sample is contained by whether the reaction is discolored or not. Occult blood.
  • the liquid permeable bearing layer is composed of at least one of a chemical fiber, a plant fiber, an animal fiber, and a mineral fiber
  • the chemical fiber comprises at least one of polyester, nylon, spandex, acrylic, and acetate fiber.
  • the animal fiber comprises at least one of animal hair, silk fiber and spider fiber
  • the mineral fiber comprises asbestos
  • the detection layer is made of plant fiber, nitrocellulose, polyethylene, polypropylene, cellulose acetate, polychlorinated It is composed of at least one of ethylene and polyvinylidene chloride.
  • the iron sample contained in the biological sample is hemoglobin iron in blood
  • the redox substance comprises at least one of hydrogen peroxide and sodium percarbonate (chemical formula: 2Na 2 CO 3 ⁇ 3H 2 O 2 )
  • the coloring matter includes at least one of o-toluidine, phenolphthalein, pilamid, guaiac, guaiac gum, tetramethylbenzidine, and an organic alcohol.
  • a occult blood test strip comprising a liquid permeable bearing layer, a detecting layer and an outer layer stacked in this order from top to bottom, wherein the liquid permeable bearing layer has water permeability and has an upper surface and a lower surface, and an upper surface of the liquid permeable bearing layer is used to carry the biological sample, and at least one folding line is provided at the middle of the upper surface for bending; the detecting layer is translucent and water permeable, and has The upper surface and the lower surface, the upper surface of the detecting layer is attached to the lower surface of the liquid permeable bearing layer, and the detecting layer is provided with at least one cavity, each cavity having at least two slots for accommodating the detecting substance, The at least two slots are respectively arranged on the two sides of the folding line in the vertical direction, and the detecting substance comprises a coloring substance and a redox substance, respectively, are accommodated in different slots, and the detecting layer is configured with a plurality of mutually disjoint Connect
  • the redox species has a function of decomposing and releasing free electrons by redox reaction of iron, and the coloring matter has a function of receiving free electrons released by the redox species and causing a change in the color of the coloring matter.
  • the biological sample is sandwiched by the upper surface of the liquid-permeable bearing layer and penetrated into the detection layer after the folding line is bent.
  • the coloring matter and the redox substance contained in the at least two slots are released to force out and concentrate in the vicinity of the folding line, and react with the biological sample to react. Whether the reaction has discoloration and whether the biological sample contains occult blood.
  • the liquid permeable bearing layer is composed of at least one of a chemical fiber, a plant fiber, an animal fiber, and a mineral fiber
  • the chemical fiber includes at least one of polyester, nylon, spandex, acrylic, and acetate fiber.
  • the animal fiber comprises at least one of animal hair, silk fiber and spider fiber
  • the mineral fiber comprises asbestos
  • the detection layer comprises plant fiber, nitrocellulose, polyethylene, polypropylene, cellulose acetate, polyvinyl chloride and Constituting at least one of polyvinylidene chloride, the iron contained in the biological sample is hemoglobin iron in blood, and the redox substance includes at least one of hydrogen peroxide and sodium percarbonate.
  • the coloring matter includes at least one of o-toluidine, phenolphthalein, pilamid, guaiac, guaiac gum, tetramethylbenzidine, and an organic alcohol.
  • the length of the connecting channel is configured not to cross the folding line.
  • the length of the connecting channel is configured to span the folding line, and the connecting channel is provided with at least one notch structure, the notch structure is configured to be vertically aligned with the folding line, and the at least one notch structure is folded in the Breaking the wire when bent to cause the coloring matter and the redox material in the at least two cells to flow out through the at least one notch structure and in contact with the biological sample penetrating into the vicinity of the at least one notch structure and reaction.
  • the length of the connecting passage may be configured not to span or cross the folding line, and if the connecting passage is to span the folding line, each connecting passage is further provided with at least one notch structure, and the notch structure is configured to be aligned in the vertical direction.
  • the function of the notch structure is to break when the folding line is bent, so that the coloring matter and the redox substance in the at least two troughs flow out through the notch structure, and the organism infiltrating into the vicinity of the notch structure The sample contacts and reacts.
  • the structure of the invention is simple and convenient to use and operate, and does not require any pre-treatment or post-treatment of the biological sample, in particular, does not cause any discomfort to the user, is quite hygienic, and can greatly improve the overall efficiency of detecting occult blood. It is very suitable for the general public in the home environment to complete the individual occult blood test without the assistance of professional medical personnel, so the industrial utilization is quite high and competitive in the market.
  • Fig. 1 shows a schematic view of a occult blood test strip according to a first embodiment of the present invention.
  • Fig. 2 is a schematic view showing a occult blood test paper according to a second embodiment of the present invention.
  • Fig. 3 is a schematic view showing a occult blood test paper according to a third embodiment of the present invention.
  • Fig. 4 is a view showing a occult blood test paper according to a fourth embodiment of the present invention.
  • Occult blood test strip 10 liquid permeable bearing layer 12; folding line 121, 241; detecting layer 14; detecting substance 141; coloring matter 1411; redox substance 1412; cavity 15, 25; slot 16; separating film 17; Channel 18; notched structure 181; outer skin 24; biological sample 30.
  • FIG. 1 is a schematic view of a occult blood test strip according to a first embodiment of the present invention.
  • the occult blood test strip 10 of the first embodiment of the present invention includes a liquid permeable bearing layer 12, a detecting layer 14, and an outer layer 24.
  • the lower surface of the liquid permeable bearing layer 12 and the lower surface of the detecting layer 14 are disposed to be attached to the upper surface of the outer skin layer 24, and the side edges of the liquid permeable bearing layer 12 are connected to the corresponding side edges of the detecting layer 14.
  • At least one folding line 121 is formed on the upper surface of the joint of the liquid-permeable bearing layer 12 and the detecting layer 14, but only one folding line 121 is shown in the drawing for convenience of explanation.
  • the upper surface of the liquid permeable bearing layer 12 is used to carry a biological sample 30, such as feces, urine or biological secretions.
  • the liquid permeable bearing layer 12 has water permeability such that the biological sample 30 is easily adhered thereto and adhered thereto, and the liquid permeable bearing layer 12 may be at least one of chemical fibers, plant fibers, animal fibers, and mineral fibers.
  • the chemical fiber comprises at least one of polyester, nylon, spandex, acrylic, acetate fiber
  • the animal fiber comprises at least one of animal hair, silk fiber and spider fiber
  • the mineral fiber comprises asbestos.
  • the detection layer 14 includes a detection substance 141 uniformly distributed in at least one area of the detection layer 14, and only the distribution is shown in the middle area.
  • the detection substance 141 can be used to perform a reaction after contacting the biological sample 30, and whether the biological sample 30 contains occult blood by the discoloration after the reaction, and the function of detecting whether the biological sample 30 contains occult blood. For example, if the biological sample 30 containing occult blood is feces, it indicates that colorectal cancer may have occurred.
  • the detection layer 14 is translucent and may be composed of at least one of plant fiber, nitrocellulose, polyethylene, polypropylene, cellulose acetate, polyvinyl chloride, and polyvinylidene chloride.
  • the folding line 121 is located at the junction of the liquid-permeable bearing layer 12 and the detecting layer 14, the liquid-permeable bearing layer 12 and the detecting layer 14 can be easily folded and contacted with each other. At this time, the liquid-permeable bearing The biological sample 30 on the layer 12 can come into contact with the detection substance 141 of the detection layer 14 to react.
  • the outer skin 24 can be used to prevent the user from coming into contact with the biological sample, improve the hygienic use, and provide appropriate mechanical strength to prevent the occult blood test paper 10 from being bent due to misuse. For example, when a certain force is applied, the outer layer 24 will Bend. Further, the outer skin layer 24 has light transmissivity, and particularly has water impermeability. Therefore, the user can see through the lower surface of the outer skin layer 24 whether or not discoloration occurs after the biological sample 30 contacts the detecting substance 141. Another function of the outer skin 24 is to improve ease of use and hygiene, as the user can hold the lower surface of the outer skin 24 and wipe the upper surface of the liquid permeable bearing layer 12 to the biological sample 30 in a wiping manner.
  • the lower surface of the outer skin layer 24 is applied, and the liquid carrier layer 12 and the detecting layer 14 are folded along the folding line 121 so that the biological sample 30 is sandwiched between the liquid-permeable bearing layer 12 and the detecting layer 14. Closed to prevent exposure of biological sample 30. Furthermore, the outer skin 24 is water impermeable so that the biological sample 30 does not penetrate the lower surface of the outer skin 24 and stains the hands of use, addressing any possible discomfort.
  • FIG. 2 is a schematic view of a occult blood test strip according to a second embodiment of the present invention, wherein the left view in FIG. 2 is a top view of the occult blood test strip of the second embodiment of the present invention, and the right view is the second view of the present invention.
  • the occult blood test strip 10 of the second embodiment includes a liquid permeable bearing layer 12, a detecting layer 14, and an outer layer 24.
  • the liquid permeable carrier layer 12, the detection layer 14 and the outer skin layer 24 have features similar to those of the first embodiment, such as the upper surface of the liquid permeable carrier layer 12 for carrying the biological sample 30 as well.
  • the difference between the first embodiment and the second embodiment includes that the liquid-permeable bearing layer 12, the detecting layer 14, and the outer layer 24 of the second embodiment are sequentially stacked from top to bottom instead of being transparent.
  • the liquid bearing layer 12 and the detecting layer 14 are connected side by side to be disposed on the outer skin 24; further, the upper surface of the liquid permeable bearing layer 12 of the second embodiment has at least one folding line 241, such as a liquid permeable bearing layer in the figure.
  • the middle area of 12, but only one folding line 241 is shown in the figure for convenience of explanation.
  • the detection layer 14 of the second embodiment has at least one cavity 25, but only one cavity 25 is shown for convenience of explanation.
  • Each of the cavities 25 has at least two slots 16 for accommodating the detection substance 141, such as on the left and right sides of the folding line 241, and the at least two slots 16 are separated by a separation film 17, wherein The separator film 17 is aligned with the folding line 241 in the vertical direction.
  • the separator film 17 is aligned with the folding line 241 in the vertical direction. It is to be noted that only two cells 16 and one separator film 17 are shown in the drawing. In fact, there may be a plurality of separator films 17 for separating adjacent cells 16, such as such cells 16 arranged in an array or circular arrangement.
  • the detecting substance 141 of the second embodiment includes a coloring matter 1411 and a redox substance 1412, which are respectively accommodated in the groove 16 on the left side and the groove 16 on the right side.
  • the redox species 1412 undergoes a redox reaction with iron in the biological sample 30 (e.g., hemoglobin iron in the blood) to be decomposed, while releasing free electrons, causing the color of the coloring matter 1411 to change to achieve discoloration. Therefore, if the biological sample 30 undergoes a color change upon contact with the detection substance 141, it means that the biological sample 30 contains a blood component, that is, contains occult blood.
  • the coloring matter 1411 may include at least one of o-toluidine, phenolphthalein, pilamid, guaiac, guaiac gum, tetramethylbenzidine, and an organic alcohol, and the redox species 1412 At least one of hydrogen peroxide and sodium percarbonate may be included.
  • the user can hold the outer skin 24, such as the left and right sides of the folding line 241, and then apply the force to the lower surface of the outer layer 24 to bend the entire occult blood test paper 10 along the folding line 241, so that The left side portion and the right side portion of the upper surface of the liquid permeable bearing layer 12 located at the folding line 241 are folded into contact with each other.
  • the biological sample 30 is enclosed and closed, and the left groove 16 and the right groove 16 are pressed against each other under the above-mentioned urging force, so that the separation film 17 is broken, and then released and mixed separately to accommodate
  • the biological sample 30 also penetrates into the liquid-permeable bearing layer 12 under the same force and reaches the detecting layer 14, thereby contacting the mixture of the coloring matter 1411 and the redox substance 1412 in the detecting layer 14. If the reaction of the biological sample 30 with the coloring matter 1411 and the redox substance 1412 causes discoloration, it indicates that the biological sample 30 has occult blood.
  • FIG. 3 is a schematic view of a occult blood test strip according to a third embodiment of the present invention, wherein the left diagram is a top view of the occult blood test strip of the third embodiment of the present invention, and the right diagram is the occult blood of the third embodiment of the present invention.
  • the occult blood test strip 10 of the third embodiment includes a liquid permeable bearing layer 12, a detecting layer 14, and an outer layer 24 which are sequentially stacked from top to bottom.
  • the upper surface of the liquid-permeable bearing layer 12 carries the biological sample 30, and the intermediate portion of the upper surface of the liquid-permeable bearing layer 12 is provided with at least one folding line 241, but only one folding line 241 is shown in the drawing.
  • the detection layer 14 has at least two cavities 15, which are respectively located on both sides of the folding line 241. Each cavity 15 has at least two slots 16 for receiving a coloring material 1411 and a redox species 1412, respectively.
  • the third embodiment of the present invention is different from the second embodiment in that the third embodiment does not have the separation film 17, and each of the cavities 15 are spaced apart from each other without being adjacent to each other, and at least two slots 16 are provided. They are respectively disposed on the two sides of the folding line 241 in the vertical direction, such as the left side and the right side in the drawing.
  • the detection layer 14 is also provided with a plurality of connecting channels 18 that do not intersect each other, each connecting channel 18 being formed by the cavity 15 extending toward the fold line 241.
  • the length of the connecting passage 18 is configured not to cross the folding line 241.
  • the occult blood test strip 10 is folded in half along the folding line 241, and thereby the liquid permeable bearing layer 12 encloses the biological sample 30, and at the same time
  • the force is also squeezed into the cells 16 on either side of the fold line 241, forcing the coloring matter 1411 and the redox species 1412 therein to flow out to concentrate near the fold line 241. Therefore, the biological sample 30 will permeate through the liquid-permeable bearing layer 12 under force to reach the detecting layer 14 and react with the mixture of the coloring matter 1411 and the redox substance 1412. If discoloration occurs after the reaction, it means that the biological sample 30 contains occult blood.
  • FIG. 4 is a schematic view of a occult blood test strip according to a fourth embodiment of the present invention, similar to the third embodiment, differs from the third embodiment in that the length of the connecting passage 18 of the fourth embodiment is configured to be
  • the folding line 241 is spanned, and each connecting channel 18 is also provided with at least one notch structure 181.
  • the notch structure 181 is configured to be aligned with the folding line 241 in the vertical direction. Therefore, when the user bends the occult blood test strip 10, the notch structure 181 of the connecting channel 18 is broken, so that the coloring matter 1411 and the redox substance 1412 in the trough 16 flow out through the notch structure 181 to be mixed, thereby infiltrating.
  • the biological sample 30 near the notch structure 181 is contacted and reacted, and whether or not the biological sample 30 contains occult blood is recognized by whether or not discoloration occurs after the reaction.
  • the fourth embodiment is characterized in that the slot 16 can be disposed in a position close to or aligned with the finger in accordance with the action of the hand-held operation, so that the finger can effectively squeeze when the force is bent and the occult blood test paper 10 is bent.
  • the groove 16 is forced to force the coloring matter 1411 and the redox substance 1412 to flow out of the notch structure 181, and the cells 16 on both sides of the folding line 241 can be spaced apart by an appropriate distance to fit the hand-held position for convenient operation.
  • the detecting layer 14 in the second, third, and fourth embodiments can directly replace the detecting layer 14 of the first embodiment. That is, the detecting layer 14 of the first embodiment can also utilize the manner in which the cells 16 of the cavities 15, 25 contain the detecting substance 141 instead of the technical features in which the detecting substance 141 is uniformly distributed in the detecting layer 14 in FIG.
  • the present invention is characterized in that the folding line is used to facilitate the user to fold the entire occult blood test paper so that the biological sample thereon is clamped and kept hygienic, and at the same time, the biological sample is infiltrated under the pressing force at the time of folding.
  • the reaction with the test substance because the outer layer under the occult blood test paper is translucent, the user can see through the lower surface of the outer surface layer whether the reaction of the biological sample contacts the detection substance is discolored, and whether the biological sample contains occult blood. If the biological sample is feces, it indicates the possibility of colorectal cancer.
  • the occult blood test strip of the present invention provides a very convenient occult blood test function, and the occult blood can be identified by wiping and folding, without any pre-treatment or post-treatment of the biological sample, especially without causing any discomfort to the user, and health.
  • Another feature of the present invention is that the overall operation and operation is simple, and the general public in a home environment can perform individual occult blood testing without the assistance of professional medical personnel, so that the industrial utilization is quite high and the market is competitive.

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Abstract

一种潜血试纸（10），包括透液性承载层（12）、检测层（14）及外表层（24），其中透液性承载层（12）具有透水性并具有上表面及下表面，上表面用于承载生物样本（30）；检测层（14）具有半透明性和透水性并包含均匀分布于至少一个区域的检测物质（141）；外表层（24）具有不透水性及透光性，透液性承载层（12）及检测层（14）的连接处的上表面形成至少一条折叠线（121，241），生物样本（30）在该折叠线（121，241）经弯折后渗透至检测层（14）中，并与检测物质（141）接触而进行反应，通过该反应是否发生变色而辨识生物样本（30）是否含有潜血。该潜血试纸（10）结构简单，操作便利且相当卫生，适合一般大众独自完成潜血检测。

Description

潜血试纸
相关申请的交叉引用
本申请主张2017年1月25日在中国提交的中国专利申请号No.201710062804.8的优先权，其全部内容通过引用包含于此。
技术领域
本发明涉及一种潜血试纸，尤其涉及利用潜血试纸沿着至少一条折叠线弯折而对折，使得生物样本通过渗入而接触到检测物质并反应，通过反应是否变色而辨识生物样本是否含有潜血，并判定有无罹患大肠癌的可能的方法。可方便民众在居家空间进行大肠癌筛检，大幅提升筛检的普及率。
背景技术
目前十大癌症中，大肠癌的发生率在近年来已爬升至第一、二位，由于饮食西化及食品安全问题频传等因素，在中国台湾大肠癌发生率节节升高。由于大肠癌的高发生率，如何筛检作为疾病的早期诊断，即成为世界性的共同议题。所幸，一般而言大肠癌的疾病进程较为缓慢。从低恶性度的肠内息肉进展到恶性度高的侵袭癌，一般需要十年左右的时间。因此，若能在大肠癌的早期即诊断，并做早期治疗，则可大幅降低大肠癌的死亡率。早期发现、早期治疗不但可以挽救相当多人的性命，也可免除治疗严重癌变的痛苦，也因此省下相当可观的社会成本。
由于大肠癌筛检所带来的可能益处，有多种筛检方法被开发出来。主要包括：化学法、免疫法、大肠镜。其中，化学法的原理是利用粪便潜血中的血红素：当粪便中有潜血存在时，血红素中的铁离子会跟外加试剂发生氧化还原反应，并通过呈色剂来作为结果判定的依据。而免疫法与化学法同属粪便采集检验，其使用带有人类血红素针对性抗体的乳胶微粒，来侦测粪便中的血红素。当粪便中有潜血存在时，乳胶微粒上的特殊抗体会与血红素结合，实验室再通过反应溶液浊度的不同，以比浊法来做粪便潜血的定量。从医疗经济层面而言，免疫法牵涉到特异性抗体的使用，不但价格较高昂，且试剂 的保存及使用对于许多实验室而言，也是一大挑战。相对地，大肠镜不同于化学法与免疫法，大肠镜筛检是直接以内视镜进行大肠腔壁的检查的方法，其优点是当发现病灶时，医师可以直接通过大肠镜来做病灶的切除，具有诊断兼治疗的好处。然而，由于其侵入性的性质，据统计每操作一千个大肠镜，可能造成一至三个大肠破裂的严重并发症。总体而言，化学法筛检有以下几点优势：优良的敏感度及特异度、低廉的价格、非侵入性、无并发症。因此，相较于免疫法及大肠镜，化学法较适合作为大肠癌筛检的方法。
然而，以过程而言，现行的筛检方法皆有其不方便之处，因而可能影响到筛检的普及。化学法与免疫法皆属于粪便检验，现行主要的过程包括：粪便检查样本的采检、粪便检查样本的送检、实验室检验、核发报告等过程。整体而言，过程相当繁复，病患必须自行从粪条中，做粪便检查样本的采样。此外，送检、检验、报告送达的过程冗长，如此不方便且繁冗的过程，可能降低民众接受筛检的意愿。而接受大肠镜检查时，民众更需要亲自前往医疗院所受检。低易达性、不足够的检查仪器、相对稀缺的肠胃科医师及麻醉科医师等等因素，都可能大幅降低大肠癌筛检的普及率。
因此，需要一种新颖的潜血试纸，利用潜血试纸沿着至少一条折叠线弯折而对折，使得生物样本借渗入而接触到检测物质并反应，通过反应是否变色而辨识生物样本是否含有潜血。所以使用者只要擦拭并对折即可辨识潜血，而不需对生物样本进行任何前处理或后处理，尤其不会造成使用者任何不适感，且相当卫生，进而解决上述现有技术的问题。
发明内容
本发明的主要目的在于提供一种潜血试纸，包括透液性承载层、检测层及外表层，其中透液性承载层具有透水性，并具有上表面及下表面，且该上表面用于承载生物样本，比如粪便、尿液或生物分泌物；检测层为半透明性且具有透水性，并具有上表面及下表面，并包含均匀分布于检测层的至少一个区域的检测物质；外表层具有不透水性及透光性，且贴附于透液性承载层的下表面以及检测层的下表面。此外，透液性承载层的侧边连接检测层的相对应的侧边，而透液性承载层及检测层的连接处的上表面形成至少一条折叠 线。
具体而言，生物样本是在该折叠线经弯折后渗透至检测层中，并与检测物质接触而进行反应，且可通过该反应是否发生变色而辨识生物样本是否含有潜血。
优选地，该透液性承载层由化学纤维、植物纤维、动物纤维以及矿物纤维中的至少一种构成，而该检测层是由植物纤维、硝化纤维、聚乙烯、聚丙烯、醋酸纤维素、聚氯乙烯以及聚偏二氯乙烯中的至少一种所构成。
优选地，该化学纤维包含的聚酯、尼龙、氨纶、压克力、醋酸纤维中的至少一种，该动物纤维包含兽毛、蚕丝纤维及蜘蛛纤维中的至少一种，该矿物纤维包含石棉。
本发明的另一个目的在于提供一种潜血试纸，包括由上而下依序堆叠的透液性承载层、检测层及外表层，其中透液性承载层具由透水性，并具有上表面及下表面，而透液性承载层的上表面用于承载生物样本，且在上表面的中间处设置至少一条折叠线，用于弯折；检测层为半透明性且具有透水性，并具有上表面及下表面，检测层的上表面贴附于透液性承载层的下表面，且检测层设有至少一个腔体，每个腔体具有用于容纳检测物质的至少两个槽格，该至少两个槽格通过分隔薄膜而分隔开，分隔薄膜在垂直方向上对齐于折叠线，检测物质包括呈色物质及氧化还原物质，分别容纳于不同的槽格内；以及外表层具透水性及透光性，为硬膜结构，且贴附于检测层的下表面。
氧化还原物质具有对铁质进行氧化还原反应而分解并释放自由电子的功能，且呈色物质具有接收氧化还原物质所释放的自由电子而使得呈色物质的颜色产生变化的功能。
生物样本在折叠线经弯折后被透液性承载层的上表面包夹住并渗透至检测层中。分隔薄膜在折叠线弯折时破裂而释放出该至少两个槽格内所容纳的呈色物质及氧化还原物质，并与生物样本接触而反应，进而通过反应是否发生变色而辨识生物样本是否含有潜血。
优选地，该透液性承载层由化学纤维、植物纤维、动物纤维以及矿物纤维中的至少一种构成，该化学纤维包含的聚酯、尼龙、氨纶、压克力、醋酸纤维中的至少一种，该动物纤维包含兽毛、蚕丝纤维及蜘蛛纤维中的至少一 种，该矿物纤维包含石棉，而该检测层是由植物纤维、硝化纤维、聚乙烯、聚丙烯、醋酸纤维素、聚氯乙烯以及聚偏二氯乙烯中的至少一种所构成。
优选地，该生物样本所包含的铁质为血液中的血红蛋白铁质，氧化还原物质包括过氧化氢以及过碳酸钠(化学式：2Na 2CO 3·3H 2O 2)中的至少一种，而呈色物质包括邻甲苯胺、酚酞、匹拉米洞、愈创木脂、愈创木胶、四甲基联苯胺以及有机醇中的至少一种。
本发明的又一个目的在于，提供一种潜血试纸，包括由上而下依序堆叠的透液性承载层、检测层及外表层，其中透液性承载层具有透水性，并具有上表面及下表面，且透液性承载层的上表面用于承载生物样本，且在上表面的中间处设置有至少一条折叠线，用于弯折；检测层为半透明性且具有透水性，并具有上表面及下表面，检测层的上表面贴附于透液性承载层的下表面，且检测层设有至少一个腔体，每个腔体具有用于容纳检测物质的至少两个槽格，该至少两个槽格在垂直方向上分别配置成位于折叠线的两侧，检测物质包括呈色物质及氧化还原物质，分别容纳于不同的槽格内，检测层配置有互不相交的多个连接通道，每个连接通道都是由相对应的腔体朝向折叠线延伸而形成；以及外表层具透水性及透光性，并为硬膜结构，且是贴附于检测层的下表面。
氧化还原物质具有对铁质进行氧化还原反应而分解并释放自由电子的功能，且呈色物质具有接收氧化还原物质所释放的自由电子而使得呈色物质的颜色产生变化的功能。
生物样本是在折叠线经弯折后被透液性承载层的上表面包夹住并渗透至检测层中。在折叠线被弯折时，该至少两个槽格内所容纳的呈色物质及氧化还原物质是被释放而迫使流出并集中到折叠线的附近，并与生物样本接触而反应，可通过该反应是否发生变色而辨识生物样本是否含有潜血。
优选地，该透液性承载层由化学纤维、植物纤维、动物纤维以及矿物纤维中的至少一种构成，该化学纤维包括聚酯、尼龙、氨纶、压克力、醋酸纤维中的至少一种，该动物纤维包括兽毛、蚕丝纤维及蜘蛛纤维中的至少一种，该矿物纤维包括石棉，而该检测层由植物纤维、硝化纤维、聚乙烯、聚丙烯、醋酸纤维素、聚氯乙烯以及聚偏二氯乙烯中的至少一种所构成，该生物样本 所包含的铁质为血液中的血红蛋白铁质，该氧化还原物质包括过氧化氢以及过碳酸钠中的至少一种，而该呈色物质包括邻甲苯胺、酚酞、匹拉米洞、愈创木脂、愈创木胶、四甲基联苯胺以及有机醇中的至少一种。其中，该连接通道的长度配置成不跨过该折叠线。
优选地，该连接通道的长度配置成跨过该折叠线，该连接通道上设有至少一个缺口结构，该缺口结构配置成在垂直方向上对齐于该折叠线，该至少一个缺口结构在该折叠线被弯折时破裂而让该至少两个槽格内的该呈色物质及该氧化还原物质经该至少一个缺口结构而流出，并与渗透到该至少一个缺口结构附近的该生物样本接触并反应。
上述的连接通道的长度可配置成不跨过或跨过折叠线，而如果连接通道是跨过折叠线，则每各连接通道进一步设有至少一个缺口结构，缺口结构配置成在垂直方向上对齐于折叠线，缺口结构的作用是在当折叠线被弯折时会破裂而让该至少两个槽格内的呈色物质及氧化还原物质经缺口结构流出，并与渗透到缺口结构附近的生物样本接触并反应。
因此，本发明的结构简单且使用及操作非常便利，不需对生物样本进行任何前处理或后处理，尤其不会造成使用者任何不适感，且相当卫生，并能大幅提高检测潜血的整体效率，很适合居家环境下的一般大众在不需要专业医疗人员的协助下独自完成个人的潜血检测，所以产业利用性相当高，具市场竞争力。
附图说明
图1显示了依据本发明的第一实施例的潜血试纸的示意图。
图2显示了依据本发明的第二实施例的潜血试纸的示意图。
图3显示了依据本发明的第三实施例的潜血试纸的示意图。
图4显示了依据本发明的第四实施例的潜血试纸的示意图。
附图标记说明：
潜血试纸10；透液性承载层12；折叠线121、241；检测层14；检测物质141；呈色物质1411；氧化还原物质1412；腔体15、25；槽格16；分隔薄膜17；连接通道18；缺口结构181；外表层24；生物样本30。
具体实施方式
以下结合附图及附图标记对本发明的实施方式做更详细的说明，以使熟习该项技艺者在研读本说明书后能予以实施。
请参阅图1，其是本发明的第一实施例的潜血试纸的示意图。如图1所示，本发明的第一实施例的潜血试纸10包括透液性承载层12、检测层14及外表层24。透液性承载层12的下表面及检测层14的下表面配置成贴附于外表层24的上表面，且透液性承载层12的侧边连接检测层14的相对应的侧边。此外，透液性承载层12及检测层14的连接处的上表面形成至少一条折叠线121，不过图中只显示一条折叠线121以方便说明。透液性承载层12的上表面用于承载生物样本30，比如粪便、尿液或生物分泌物。
具体而言，透液性承载层12具有透水性，使得生物样本30很容易沾黏而附着在其上，且透液性承载层12可由化学纤维、植物纤维、动物纤维以及矿物纤维中的至少一种构成。其中化学纤维包括聚酯、尼龙、氨纶、压克力、醋酸纤维中的至少一种，动物纤维包括兽毛、蚕丝纤维及蜘蛛纤维中的至少一种，矿物纤维包括石棉。
检测层14包含均匀分布于检测层14的至少一个区域的检测物质141，图中只显示分布于中间区域。检测物质141可用于在接触到生物样本30后进行反应，并通过反应后是否发生变色而辨识生物样本30是否含有潜血，达到检测生物样本30是否含有潜血的功能。例如，如果含有潜血的生物样本30为粪便，则表示可能已罹患大肠癌。此外，检测层14为半透明性，并可由植物纤维、硝化纤维、聚乙烯、聚丙烯、醋酸纤维素、聚氯乙烯以及聚偏二氯乙烯中的至少一种所构成。
由于上述的折叠线121位于透液性承载层12及检测层14的连接处，因此可方便弯折而使得透液性承载层12及检测层14相互对折而接触，此时，透液性承载层12上的生物样本30可接触到检测层14的检测物质141而发生反应。
外表层24可用于防止用户接触到生物样本，改善使用时的卫生性，并能提供适当的机械强度，防止潜血试纸10因误用而弯折，比如在超过一定施力时，外表层24会弯折。此外，外表层24具有透光性，尤其具有不透水性， 因此，使用者可透过外表层24的下表面而观看到生物样本30接触检测物质141后是否发生变色。外表层24的另一功能是改善使用的方便性及卫生性，因为使用者可手持外表层24的下表面，并以擦拭的方式让透液性承载层12的上表面沾黏到生物样本30，接着施力于外表层24的下表面，沿着折叠线121对折透液性承载层12及检测层14，使得生物样本30被包夹在透液性承载层12及检测层14之间而封闭，可防止生物样本30外露。再者，外表层24具有不透水性，因而生物样本30不会渗透到外表层24的下表面而沾污到使用的手部，解决任何可能的不适感。
参考图2，其是本发明的第二实施例的潜血试纸的示意图，其中图2中的左图为本发明的第二实施例的潜血试纸的上视图，而右图为本发明的第二实施例的潜血试纸的侧面剖视图。如图2所示，第二实施例的潜血试纸10包括透液性承载层12、检测层14及外表层24。透液性承载层12、检测层14及外表层24具有类似于第一实施例的特征，比如透液性承载层12的上表面同样是用于承载生物样本30。不过，第一实施例与第二实施例之间的差异点包括：第二实施例的透液性承载层12、检测层14及外表层24是由上而下依序堆叠，而不是将透液性承载层12、检测层14并排连接而配置在外表层24上；此外，第二实施例的透液性承载层12的上表面具有至少一条折叠线241，比如位于图中透液性承载层12的中间区域，不过图中只显示一条折叠线241以方便说明。
更加具体而言，第二实施例的检测层14具有至少一个腔体25，不过图中只显示一个腔体25以方便说明。每个腔体25具有用于容纳检测物质141的至少两个槽格16，比如位于折叠线241的左侧及右侧，且该至少两个槽格16通过分隔薄膜17而分隔开，其中分隔薄膜17在垂直方向上对齐于折叠线241。要注意的是，图中只显示两个槽格16以及一个分隔薄膜17。实际上，可具有多个分隔薄膜17，用于分隔相邻的槽格16，比如以数组方式或圆形排列而配置的这样的槽格16。
此外，第二实施例的检测物质141包括呈色物质1411及氧化还原物质1412，分别容纳于左侧的槽格16及右侧的槽格16内。氧化还原物质1412会与生物样本30中的铁质(比如血液中的血红蛋白铁质)进行氧化还原反应而分 解，同时释放自由电子，使得呈色物质1411的颜色产生变化，达到变色作用。因此，如果生物样本30在接触到检测物质141后会产生颜色变化，则表示生物样本30中含有血液成分，也即含有潜血。
较佳地，呈色物质1411可包括邻甲苯胺、酚酞、匹拉米洞、愈创木脂、愈创木胶、四甲基联苯胺以及有机醇中的至少一种，而氧化还原物质1412可包括过氧化氢以及过碳酸钠中的至少一种。
在实际使用上，使用者可手持外表层24，比如对齐于折叠线241的左侧及右侧，接着施力于外表层24的下表面而沿着折叠线241弯折整个潜血试纸10，使得透液性承载层12的上表面中位于折叠线241的左侧部分和右侧部分会相互对折而接触。此时，生物样本30被包夹而封闭住，而且左侧的槽格16及右侧的槽格16会在上述的施力下相互挤压，使得分隔薄膜17破裂，进而释放并混合分别容纳在左侧的槽格16及右侧的槽格16内的呈色物质1411及氧化还原物质1412。同时，生物样本30也在相同施力下渗入透液性承载层12并到达检测层14，进而接触到检测层14中的呈色物质1411和氧化还原物质1412的混合物。如果生物样本30与呈色物质1411及氧化还原物质1412的反应会发生变色，则表示生物样本30具有潜血。
参考图3，其是本发明的第三实施例的潜血试纸的示意图，其中左图为本发明的第三实施例的潜血试纸的上视图，而右图为本发明的第三实施例的潜血试纸的侧面剖示图。如图3所示，第三实施例的潜血试纸10包括由上而下依序堆叠的透液性承载层12、检测层14及外表层24。类似于第二实施例，透液性承载层12的上表面承载生物样本30，透液性承载层12的上表面的中间区域配置有至少一条折叠线241，不过图中只显示一条折叠线241，而且检测层14具有至少两个腔体15，分别位于折叠线241的两侧。每个腔体15具有至少两个槽格16，用于分别容纳呈色物质1411及氧化还原物质1412。
不过，本发明的第三实施例与第二实施例的不同之处在于，第三实施例不具有分隔薄膜17，且每个腔体15相互间隔开而不相邻，至少两个槽格16在垂直方向上分别配置成位于折叠线241的两侧，比如图中的左侧及右侧。尤其，检测层14还配置有互不相交的多个连接通道18，每个连接通道18都是由腔体15朝向折叠线241延伸而形成。连接通道18的长度配置成不跨过 折叠线241。因此，使用者在手持外表层24的下表面而施力弯折时，潜血试纸10会沿着折叠线241而对折，并由此透液性承载层12包夹住生物样本30，同时该施力也挤压到位于折叠线241两侧的槽格16，迫使其中的呈色物质1411及氧化还原物质1412流出而集中到折叠线241的附近。所以生物样本30会在施力下渗透穿过透液性承载层12而到达检测层14内，并与呈色物质1411和氧化还原物质1412的混合物反应。如果反应后会发生变色，则表示生物样本30含有潜血。
此外，参考图4，其是本发明的第四实施例的潜血试纸的示意图，类似于第三实施例，与第三实施例的差异点在于，第四实施例的连接通道18的长度配置成跨过折叠线241，而且每个连接通道18还设有至少一个缺口结构181。缺口结构181配置成在垂直方向上对齐于折叠线241。因此，使用者在施力弯折潜血试纸10时，连接通道18的缺口结构181会破裂，使得槽格16内的呈色物质1411及氧化还原物质1412经缺口结构181流出而混合，从而与渗透到缺口结构181附近的生物样本30接触并反应，通过反应后是否发生变色而辨识生物样本30是否含有潜血。
进一步而言，第四实施例的特点在于，可配合手持操作的动作而将槽格16配置在靠近或对准手指的位置，使得手指在施力而弯折潜血试纸10时，能有效地挤压槽格16，从而迫使其中的呈色物质1411及氧化还原物质1412由缺口结构181流出，而且位于折叠线241两侧的槽格16可相隔开适当距离以配合手持位置，方便操作使用，因为两侧槽格16的相隔距离太短或太长时，比如太过集中到或远离折叠线241，都会造成对折时手指无法有效施力到槽格16，导致对呈色物质1411及氧化还原物质1412的挤压效果不佳，严重影响检测潜血的功效。
更要注意的是，第二、第三、第四实施例中的检测层14可直接取代第一实施例的检测层14。也即，第一实施例的检测层14也可利用腔体15、25的槽格16包含检测物质141的方式，取代图1中检测物质141均匀分布于检测层14的技术特征。
综上所述，本发明的特点在于利用折叠线以方便使用者对折整个潜血试纸，使得其上的生物样本被包夹住而保持卫生，同时在对折时的挤压施力下 让生物样本渗入而与检测物质反应，由于潜血试纸底下的外表层具有透光性，所以使用者可透过外表层的下表面而观看到生物样本接触检测物质后的反应是否发生变色，辨识生物样本是否含有潜血，如果生物样本为粪便，则表示有罹患大肠癌的可能。因此，本发明的潜血试纸提供非常方便的潜血检测功能，只要擦拭并对折即可辨识潜血，而不需对生物样本进行任何前处理或后处理，尤其不会造成使用者任何不适感，且相当卫生。
本发明的另一特点为整体的使用操作简单，适合居家环境下的一般大众在不需要专业医疗人员的协助下即可独自完成个人的潜血检测，所以产业利用性相当高，具市场竞争力。
以上所述者仅用于解释本发明的较佳实施例，并非企图据以对本发明做任何形式上的限制，是以，凡有在相同的发明精神下所作有关本发明的任何修饰或变更，皆仍应包括在本发明意图保护的范畴。

Claims (10)

  1. 一种潜血试纸，其特征在于，包括：
    透液性承载层，该透液性承载层具有透水性，并具有上表面及下表面，所述上表面用于承载生物样本；
    检测层，该检测层具有半透明性和透水性，并具有上表面及下表面，所述检测层包含均匀分布于检测层的至少一个区域的检测物质；以及
    外表层，该外表层具有不透水性及透光性，且贴附于所述透液性承载层的下表面以及所述检测层的下表面，
    其中所述透液性承载层的侧边连接所述检测层的相对应的侧边，而所述透液性承载层及所述检测层的连接处的上表面形成至少一个折叠线，所述生物样本在该折叠线经弯折后渗透至所述检测层中，并与所述检测物质接触而进行反应，且通过该反应是否发生变色而辨识所述生物样本是否含有潜血。
  2. 根据权利要求1所述的潜血试纸，其特征在于，所述透液性承载层由化学纤维、植物纤维、动物纤维以及矿物纤维中的至少一种构成，而所述检测层由植物纤维、硝化纤维、聚乙烯、聚丙烯、醋酸纤维素、聚氯乙烯以及聚偏二氯乙烯中的至少一种所构成。
  3. 根据权利要求2所述的潜血试纸，其特征在于，所述化学纤维包括聚酯、尼龙、氨纶、压克力、醋酸纤维中的至少一种，所述动物纤维包括兽毛、蚕丝纤维及蜘蛛纤维中的至少一种，所述矿物纤维包括石棉。
  4. 一种潜血试纸，其特征在于，包括：
    透液性承载层，该透液性承载层具有透水性，并具有上表面及下表面，所述上表面用于承载生物样本，且在该上表面的中间处设置至少一条折叠线，用于弯折；
    检测层，该检测层具有半透明性和透水性，并具有上表面及下表面，所述检测层的上表面贴附于所述透液性承载层的下表面，且所述检测层设有至少一个腔体，每个腔体具有用于容纳检测物质的至少两个槽格，该至少两个槽格是通过分隔薄膜而分隔开，所述分隔薄膜在垂直方向上对齐于所述折叠线，所述检测物质包括呈色物质及一氧化还原物质，分别容纳于不同的槽格 内；以及
    外表层，该外表层具透水性及透光性，且贴附于所述检测层的下表面，
    其中，所述氧化还原物质具有对铁质进行氧化还原反应而分解并释放自由电子的功能，且所述呈色物质具有接收所述氧化还原物质所释放的自由电子而使得所述呈色物质的颜色产生变化的功能，所述生物样本在所述折叠线经弯折后被所述透液性承载层的上表面包夹住并渗透至所述检测层中，且所述分隔薄膜在所述折叠线弯折时破裂而释放出至少两个槽格内所容纳的所述呈色物质及该氧化还原物质，并与所述生物样本接触而反应，从而通过该反应是否发生变色而辨识所述生物样本是否含有潜血。
  5. 根据权利要求4所述的潜血试纸，其特征在于，所述透液性承载层由化学纤维、植物纤维、动物纤维以及矿物纤维中的至少一种构成，所述化学纤维包括聚酯、尼龙、氨纶、压克力、醋酸纤维中的至少一种，所述动物纤维包括兽毛、蚕丝纤维及蜘蛛纤维中的至少一种，所述矿物纤维包括石棉，而所述检测层由植物纤维、硝化纤维、聚乙烯、聚丙烯、醋酸纤维素、聚氯乙烯以及聚偏二氯乙烯中的至少一种所构成。
  6. 根据权利要求5所述的潜血试纸，其特征在于，所述生物样本所包含的铁质为血液中的血红蛋白铁质，所述氧化还原物质包括过氧化氢以及过碳酸钠中的至少一种，而所述呈色物质包括邻甲苯胺、酚酞、匹拉米洞、愈创木脂、愈创木胶、四甲基联苯胺以及有机醇中的至少一种。
  7. 一种潜血试纸，其特征在于，包括：
    透液性承载层，该透液性承载层具有透水性，并具有上表面及下表面，所述上表面用于承载生物样本，且在该上表面的中间处设置至少一条折叠线，用于弯折
    检测层，该检测层具有半透明性和透水性，并具有上表面及下表面，所述检测层的上表面贴附于所述透液性承载层的下表面，且所述检测层设有至少一个腔体，每个腔体具有用于容纳检测物质的至少两个槽格，所述至少两个槽格在垂直方向上分别配置成位于所述折叠线的两侧，所述检测物质包括呈色物质及氧化还原物质，分别容纳于不同的槽格内，所述检测层配置有互不相交的多个连接通道，每个连接通道都是由相对应的腔体朝向所述折叠线 延伸而形成；以及
    外表层，该外表层具有透水性及透光性，且贴附于所述检测层的下表面，
    其中所述氧化还原物质具有对铁质进行氧化还原反应而分解并释放自由电子的功能，且所述呈色物质具有接收所述氧化还原物质所释放的自由电子而使得所述呈色物质的颜色产生变化的功能，所述生物样本在所述折叠线经弯折后被所述透液性承载层的上表面包夹住并渗透至所述检测层中，而在所述折叠线被弯折时，所述至少两个槽格内所容纳的所述呈色物质及所述氧化还原物质被释放而迫使流出并集中到所述折叠线的附近，并与所述生物样本接触而反应，通过该反应是否发生变色而辨识所述生物样本是否含有潜血。
  8. 根据权利要求7所述的潜血试纸，其特征在于，所述透液性承载层由化学纤维、植物纤维、动物纤维以及矿物纤维中的至少一种构成，所述化学纤维包括聚酯、尼龙、氨纶、压克力、醋酸纤维中的至少一种，所述动物纤维包括兽毛、蚕丝纤维及蜘蛛纤维中的至少一种，所述矿物纤维包括石棉，而所述检测层由植物纤维、硝化纤维、聚乙烯、聚丙烯、醋酸纤维素、聚氯乙烯以及聚偏二氯乙烯中的至少一种所构成，所述生物样本所包含的铁质为血液中的血红蛋白铁质，所述氧化还原物质包括过氧化氢以及过碳酸钠中的至少一种，而所述呈色物质包括邻甲苯胺、酚酞、匹拉米洞、愈创木脂、愈创木胶、四甲基联苯胺以及有机醇中的至少一种。
  9. 根据权利要求7所述的潜血试纸，其特征在于，所述连接通道的长度配置成不跨过所述折叠线。
  10. 根据权利要求7所述的潜血试纸，其特征在于，所述连接通道的长度配置成跨过所述折叠线，所述连接通道上设有至少一个缺口结构，该缺口结构配置成在垂直方向上对齐于所述折叠线，所述至少一个缺口结构在所述折叠线被弯折时破裂而让所述至少两个槽格内的所述呈色物质及所述氧化还原物质经所述至少一个缺口结构而流出，并与渗透到所述至少一个缺口结构附近的该生物样本接触并反应。
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