CN103630685A - Test strip card - Google Patents
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- CN103630685A CN103630685A CN201310565273.6A CN201310565273A CN103630685A CN 103630685 A CN103630685 A CN 103630685A CN 201310565273 A CN201310565273 A CN 201310565273A CN 103630685 A CN103630685 A CN 103630685A
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- 238000012360 testing method Methods 0.000 title claims abstract description 285
- 238000001514 detection method Methods 0.000 claims abstract description 143
- 238000003908 quality control method Methods 0.000 claims abstract description 53
- 238000006243 chemical reaction Methods 0.000 claims description 31
- 239000012528 membrane Substances 0.000 claims description 26
- 239000000126 substance Substances 0.000 claims description 23
- 238000004458 analytical method Methods 0.000 claims description 15
- 239000000203 mixture Substances 0.000 claims description 12
- 239000002096 quantum dot Substances 0.000 claims description 12
- 239000000020 Nitrocellulose Substances 0.000 claims description 10
- 229920001220 nitrocellulos Polymers 0.000 claims description 10
- 239000004033 plastic Substances 0.000 claims description 10
- 229920000728 polyester Polymers 0.000 claims description 10
- 239000007788 liquid Substances 0.000 claims description 9
- 239000000463 material Substances 0.000 claims description 9
- 206010028980 Neoplasm Diseases 0.000 claims description 8
- 239000003814 drug Substances 0.000 claims description 8
- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 claims description 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 6
- 101100379079 Emericella variicolor andA gene Proteins 0.000 claims description 5
- 239000004677 Nylon Substances 0.000 claims description 5
- OAICVXFJPJFONN-UHFFFAOYSA-N Phosphorus Chemical compound [P] OAICVXFJPJFONN-UHFFFAOYSA-N 0.000 claims description 5
- BUGBHKTXTAQXES-UHFFFAOYSA-N Selenium Chemical compound [Se] BUGBHKTXTAQXES-UHFFFAOYSA-N 0.000 claims description 5
- 229920002301 cellulose acetate Polymers 0.000 claims description 5
- 238000004587 chromatography analysis Methods 0.000 claims description 5
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- 239000006249 magnetic particle Substances 0.000 claims description 5
- 238000012544 monitoring process Methods 0.000 claims description 5
- 229920001778 nylon Polymers 0.000 claims description 5
- 229910052761 rare earth metal Inorganic materials 0.000 claims description 5
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- 208000023275 Autoimmune disease Diseases 0.000 claims description 4
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- 210000004369 blood Anatomy 0.000 claims description 4
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- 230000028327 secretion Effects 0.000 claims description 4
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- 238000010521 absorption reaction Methods 0.000 claims 1
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- 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
- G01N33/483—Physical analysis of biological material
- G01N33/487—Physical analysis of biological material of liquid biological material
- G01N33/4875—Details of handling test elements, e.g. dispensing or storage, not specific to a particular test method
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- 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
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/558—Immunoassay; Biospecific binding assay; Materials therefor using diffusion or migration of antigen or antibody
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- 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
- G01N33/58—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving labelled substances
- G01N33/588—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving labelled substances with semiconductor nanocrystal label, e.g. quantum dots
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2800/00—Detection or diagnosis of diseases
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Abstract
The invention belongs to the field of in-vitro diagnosis, and particularly relates to a test strip card which is provided with a storage medium (14) for storing a tested object standard curve, coefficient parameters or other detection information. The test strip card comprises a card box (3) and a test strip (2), wherein one end of the card box (3) is open to form a test strip slot (13), and the test strip (2) is in a card box (3) instant-plug structure; and a storage medium (14) is installed on the card box (3). When detecting a sample, one end of a shape suction pad (4) of the test strip (2) inserted into the card box (3) excessively protrudes out of the open end of the card box (3) so as to impregnate and absorb the sample, and an instrument with signal detection function acquires characteristic signals of a test strip (2) detection belt (6) and a quality control belt (7) and calculates the sample single component or multicomponent concentration in combination with the tested object standard curve or coefficient parameters simultaneously red from the storage medium (14) by the instrument. The test strip card for detecting samples has is simple and quick, and has the characteristics of high sensitivity, objective result, high use flexibility and the like.
Description
Technical Field
The invention belongs to the field of in-vitro diagnosis, and particularly relates to a test strip card which is provided with a storage medium 14 for storing information for detection such as standard curves or coefficient parameters of a detected object and can be used for rapidly detecting single components or multiple components of a sample by combining with an instrument with a signal detection function.
Background
Immunochromatographic strip technology, which is mainly represented by a colloidal gold strip, is now widely used in various aspects of immunoassays. The technique is simple and rapid, and the result can be obtained within minutes. The disadvantages are as follows: (1) only can qualitatively detect the sample, is difficult to realize the quantitative detection of the sample, and is more difficult to realize the rapid quantitative detection of the multi-component of the sample. (2) For some samples with extremely low antigen or antibody content, the result is difficult to judge by naked eyes, and the detection sensitivity is low.
The method for quantifying the concentration of a detected object by using a standard curve of a detected object standard is a main method for quantifying the concentration of a sample in the field of detection at present. The standard curve making technology is strong, the process is complicated, and professional technicians cannot be left. Storage media developed recently in the information field, such as RFID tags (also called radio frequency identification tags), IC chips, magnetic codes, bar codes, etc., are now widely used in the fields of computers, communications, electronics, commerce, transportation control management, etc., for information access identification. The RFID label has small volume and large capacity of stored information, does not need manual intervention for identification, is an ideal means for information access identification, but rarely is used in the field of biomedical detection.
In order to overcome the defects of the prior art, the invention provides a test strip card which is provided with a storage medium 14 for storing information for detection such as a standard curve or coefficient parameters of a detected object (an operator does not need to make the standard curve of the detected object when detecting a sample) and can be combined with an instrument with a signal detection function to quickly realize single-component or multi-component quantitative (qualitative/semi-quantitative) detection of the sample. The invention is used for sample detection, and has the characteristics of simplicity, convenience, rapidness, high sensitivity, objective result and the like.
Disclosure of Invention
The technical scheme of the invention is as follows:
the test strip card comprises a card box 3 and a test strip 2. The test strip 2 comprises a sample absorbing pad 4, a marking pad 5, an analysis film 8 and a water absorbing pad 9 which are sequentially overlapped and fixed on the bottom lining 1. The analytical membrane 8 has a detection zone 6 and a quality control zone 7. One end of the card box 3 and the upper box surface opening of the card box end form a test strip slot opening 13, so that the test strip 2 can be inserted into the card box 3 at present. Test strip 2 is an off-plug configuration of cartridge 3. When detecting a sample, one end of the sample absorbing pad 4 of the test strip 2 inserted into the card box 3 is extended out of the opening end of the card box 3 in an interference manner to soak and absorb the sample. The upper case surface of the cartridge 3 is opened with a detection window 11 at a position corresponding to the test strip analysis film 8. The cartridge 3 is provided with a storage medium 14.
The label pad 5 of the test strip 2 is coated with a single specific molecule related to detection of a target analyte labeled with a single label, or: and detecting a mixture of related specific molecules by using each target object correspondingly marked by different markers.
The test strip 2 may have one or more test strips 6. The detection zone 6 is coated with another specific molecule related to the detection of a target object, or: coated with a mixture of other specific molecules relevant for the detection of each target test substance.
The quality control strip 7 of the test strip 2 is coated with a quality control substance. The quality control substance comprises a secondary antibody.
The storage medium 14 on the cartridge 3 includes, but is not limited to, an RFID tag, an IC chip, a magnetic code, a bar code, or the like. The storage medium 14 stores a standard curve or coefficient parameter of the detected object for quantifying the sample concentration of the same batch of test strips 2, a reference monitoring value of the signal intensity of the control band of the quality of the test strips, a batch number of the test strips, an expiration date of the test strips, a password of the storage medium, a reference value of clinical indexes, information of manufacturers of the test strips and the like, and can read information such as identity information, information of testers, sample names, sample numbers, detection dates, detection results and the like of the detected objects.
The standard curve of the object stored in the storage medium 14 has various forms, including but not limited to the following curves: concentration of standard substance series to be detectedA Detection belt/A Quality control bandThe corresponding relation curve between the two curves; or, the concentration of the standard substance series of the object to be tested andA detection belt/（A Detection belt+A Quality control band) The corresponding relation curve between the two. Wherein,A detection beltThe signal intensity of the detection zone measured for the series concentration of the object standard,A quality control bandAnd the signal intensity of the quality control band measured for the series concentration of the detected object standard.
A strip reaction endpoint indicator 10 may also be attached to the absorbent pad 9 of strip 2 of the present invention. Accordingly, the cartridge 3 has a viewing window 12 corresponding to the test strip reaction endpoint indicator 10. The strip reaction endpoint indicator 10 includes, but is not limited to, a pH paper having a color change in the range of 5-9.
The marking pad 5 of the test strip 2 is a glass fiber film; the analysis membrane 8 of the test strip 2 is a nitrocellulose membrane, a nylon membrane or a mixed membrane of nitrocellulose and cellulose acetate; the bottom liner 1 of the test strip 2 is made of polyester or a plastic plate; the cartridge 3 is made of polyester, plastic, rigid paper material, or other material.
The test strip 2 of the present invention is any test strip, including but not limited to quantum dot labeling test strip, colloidal gold labeling test strip, colloidal selenium labeling test strip, upconversion phosphor labeling test strip, nano rare earth fluorescent complex labeling test strip, nano magnetic particle labeling test strip, time resolution chromatography test strip, and chemiluminescence test strip.
The test strip 2 of the present invention is a disposable article. The card box 3 and the storage medium 14 on the card box 3 are used as accessories for the test strips 2 in the same batch.
When the test strip card is used for sample detection, the test strip 2 is currently inserted into the card box 3, and the interference extending end of the test strip 2 inserted into the card box 3 is soaked and absorbed with a liquid sample. After the sample finishes the test strip reaction on the test strip 2, collecting the characteristic signals of a detection band 6 and a quality control band 7 of the test strip 2 by an instrument with a signal detection function (such as a strip reader, a fluorescence detector, a magnetic signal detector and the like) and quantitatively obtaining the single-component or multi-component concentration of the sample by combining the standard curve or coefficient parameter of the detected object which is simultaneously read from a storage medium 14 by the instrument; or, after the sample completes the strip reaction on the test strip 2, the sample components are qualitatively or semi-quantitatively detected according to the display conditions of the test strip detection belt 6 and the quality control belt 7 of the test strip card.
The sample to be detected of the test strip card can be clinical or non-clinical blood, body fluid, urine, saliva, genital secretion or other liquid samples or viscous samples, wherein the clinical samples comprise samples of infectious diseases, hormones, cardiovascular diseases, tumors, cancers, diabetes, autoimmune diseases and the like, and the non-clinical samples comprise samples of food detection, environmental pollution detection, pesticide residue detection, biological contamination detection, biological agent detection, veterinary medicine detection, drug detection and the like.
The invention has the following beneficial effects:
(1) the sample components can be detected rapidly and quantitatively (including qualitative or semi-quantitative detection of the sample components). The test strip card of the present invention is provided with a storage medium 14, and the storage medium 14 stores information for detection such as a standard curve or a coefficient parameter of an object to be detected. After the chromatographic reaction of the sample to be detected on the test strip is completed, the instrument with a signal detection function collects the characteristic signals of the detection belt 6 and the quality control belt 7 of the test strip 2 in the test strip card and combines the standard curve or coefficient parameter of the detected object which is simultaneously read from the storage medium 14 by the instrument, so that the component concentration of the sample can be rapidly and quantitatively obtained within minutes.
(2) When the test strip 2 in the test strip card is marked by the quantum dots, the quick and accurate quantitative detection of multiple components of a sample can be realized simultaneously. Quantum Dots (QDs) are semiconductor nanocrystals which have excellent spectral characteristics and photochemical stability and are developed in the 90 s of the 20 th century, and have the characteristics of high fluorescence luminous efficiency, wide excitation spectral line range, narrow emission spectral line range, long fluorescence service life, large Stokes shift, similar particle size to biomolecules, multifunction after surface modification and the like. The quantum dots with different particle sizes, types and structures can generate continuous fluorescence peak spectrums with different characteristic wavelengths, and the fluorescence peak spectrums with the characteristic wavelengths generated by the quantum dot mixture are not overlapped. Different quantum dots are adopted to mark corresponding reaction molecules of a detected object respectively, a mixture of the different quantum dots is coated on a test strip of the test strip card to react with a sample to be detected, and the multi-component concentration of the sample can be rapidly and accurately quantified within a few minutes by measuring a specific fluorescence signal of the test strip. The existing test strip technology can only detect a sample qualitatively, cannot realize quantitative detection of the sample and cannot realize multi-component quantitative detection of the sample.
(3) The reagents and materials in the strip card are not subject to activity inactivation and can be stored at room temperature for a long period of time.
Drawings
FIG. l: the plan structure diagram of the first preferred scheme of the test strip card (the test strip in the test strip card adopts a detection line)
FIG. 2: side view structure diagram of test strip in card box (the test strip adopts a detection line)
FIG. 3: the plan structure diagram of the first preferred scheme of the test strip card (the test strip in the test strip card adopts a plurality of detection lines)
FIG. 4: side view structure diagram of test strip in card box (the test strip adopts a plurality of detection lines)
FIG. 5: another preferred embodiment of the test strip card of the present invention is a structure diagram of a top view (showing the test strip therein using one test line)
FIG. 6: side view structure diagram of test strip in card box of another preferred scheme of the test strip card of the invention (the test strip adopts a detection line)
FIG. 7: another preferred embodiment of the test strip card of the present invention is a structure diagram of a top view (showing the test strip therein using a plurality of test lines)
FIG. 8: side view structure diagram of test strip in card box of another preferred scheme of the test strip card of the invention (the test strip adopts a plurality of detection lines)
The sequence numbers are as follows:
1. the test strip comprises a bottom lining, 2, a test strip, 3, a card box, 4, a sample absorbing pad, 5, a marking pad, 6, a detection strip, 7, a quality control strip, 8, an analysis film, 9, a water absorbing pad, 10, a test strip reaction end point indicating label, 11, a detection window, 12, an observation window, 13, a test strip socket opening, 14 and a storage medium.
Detailed Description
The following examples and figures are only intended to illustrate the invention further and the person skilled in the art should not be construed as limiting the scope of the invention.
Example one
Fig. 1-4 illustrate a first embodiment. The first embodiment is one of the preferred solutions of the test strip card of the present invention.
In fig. 1-4, the test strip card of the preferred embodiment includes a cartridge 3 and a test strip 2. The test strip 2 comprises a sample absorbing pad 4, a marking pad 5, an analysis film 8 and a water absorbing pad 9 which are sequentially overlapped and fixed on the bottom lining 1. The analytical membrane 8 has a detection zone 6 and a quality control zone 7. One end of the card box 3 and the upper box surface opening of the card box end form a test strip slot opening 13, so that the test strip 2 can be inserted into the card box 3 at present. Test strip 2 is an off-plug configuration of cartridge 3. When detecting a sample, one end of the sample absorbing pad 4 of the test strip 2 inserted into the card box 3 is extended out of the opening end of the card box 3 in an interference manner to soak and absorb the sample. The upper case surface of the cartridge 3 is opened with a detection window 11 at a position corresponding to the test strip analysis film 8. The cartridge 3 is provided with a storage medium 14.
The label pad 5 of the test strip 2 is coated with a single specific molecule related to detection of a target analyte labeled with a single label, or: and detecting a mixture of related specific molecules by using each target object correspondingly marked by different markers.
The test strip 2 may have one or more test strips 6 (shown in fig. 1 and 2) or a plurality of test strips 6 (shown in fig. 3 and 4). The detection zone 6 is coated with another specific molecule related to the detection of a target object, or: coated with a mixture of other specific molecules relevant for the detection of each target test substance.
The quality control strip 7 of the test strip 2 is coated with a quality control substance. The quality control substance comprises a secondary antibody.
The storage medium 14 on the cartridge 3 includes, but is not limited to, an RFID tag, an IC chip, a magnetic code, a bar code, or the like. The storage medium 14 stores a standard curve or coefficient parameter of the detected object for quantifying the sample concentration of the same batch of test strips 2, a reference monitoring value of the signal intensity of the control band of the quality of the test strips, a batch number of the test strips, an expiration date of the test strips, a password of the storage medium, a reference value of clinical indexes, information of manufacturers of the test strips and the like, and can read information such as identity information, information of testers, sample names, sample numbers, detection dates, detection results and the like of the detected objects.
The standard curve of the object stored in the storage medium 14 has various forms, including but not limited to the following curves: concentration of standard substance series to be detectedA Detection belt/A Quality control bandThe corresponding relation curve between the two curves; or, the concentration of the standard substance series of the object to be tested andA detection belt/（A Detection belt+A Quality control band) The corresponding relation curve between the two. Wherein,A detection beltThe signal intensity of the detection zone measured for the series concentration of the object standard,A quality control bandAnd the signal intensity of the quality control band measured for the series concentration of the detected object standard.
The marking pad 5 of the test strip 2 is a glass fiber film; the analysis membrane 8 of the test strip 2 is a nitrocellulose membrane, a nylon membrane or a mixed membrane of nitrocellulose and cellulose acetate; the bottom liner 1 of the test strip 2 is made of polyester or a plastic plate; the cartridge 3 is made of polyester, plastic, rigid paper material, or other material.
The test strip 2 is any test strip including, but not limited to, quantum dot labeling test strips, colloidal gold labeling test strips, colloidal selenium labeling test strips, upconversion phosphor labeling test strips, nano rare earth fluorescent complex labeling test strips, nano magnetic particle labeling test strips, time-resolved chromatography test strips, and chemiluminescence test strips.
The strip 2 is a disposable item. The card box 3 and the storage medium 14 on the card box 3 are used as accessories for the test strips 2 in the same batch.
When the test strip card is used for detecting a sample, the test strip 2 is inserted into the card box 3 at present, and the interference extending end of the test strip 2 inserted into the card box 3 is soaked and absorbs the liquid sample. After the liquid sample completes the test strip reaction on the test strip 2, the characteristic signals of a detection belt 6 and a quality control belt 7 of the test strip 2 are collected by an instrument with a signal detection function (such as a strip reader, a fluorescence detector, a magnetic signal detector and the like), and the single-component or multi-component concentration of the sample is quantitatively obtained by combining the standard curve or coefficient parameter of the detected object which is simultaneously read from a test strip card storage medium 14 by the instrument; or, after the liquid sample completes the strip reaction on the test strip 2, the sample components are qualitatively or semi-quantitatively detected according to the display conditions of the test strip detection belt 6 and the quality control belt 7 of the test strip card.
The sample to be detected of the test strip card can be clinical or non-clinical blood, body fluid, urine, saliva, genital secretion or other liquid samples or viscous samples, wherein the clinical samples comprise samples of infectious diseases, hormones, cardiovascular diseases, tumors, cancers, diabetes, autoimmune diseases and the like, and the non-clinical samples comprise samples of food detection, environmental pollution detection, pesticide residue detection, biological contamination detection, biological agent detection, veterinary medicine detection, drug detection and the like.
Example two
Fig. 5-8 illustrate the second embodiment. The second embodiment is another preferred scheme of the test strip card of the invention.
In fig. 5-8, the test strip card of the preferred embodiment includes a cartridge 3 and a test strip 2. The test strip 2 comprises a sample absorbing pad 4, a marking pad 5, an analysis film 8, a water absorbing pad 9 and a test strip reaction endpoint indicating label 10 which are sequentially overlapped and fixed on the bottom lining 1. The analytical membrane 8 has a detection zone 6 and a quality control zone 7. One end of the card box 3 and the upper box surface opening of the card box end form a test strip slot opening 13, so that the test strip 2 can be inserted into the card box 3 at present. Test strip 2 is an off-plug configuration of cartridge 3. When detecting a sample, one end of the sample absorbing pad 4 of the test strip 2 inserted into the card box 3 is extended out of the opening end of the card box 3 in an interference manner to soak and absorb the sample. The upper case surface of the cartridge 3 is opened with a detection window 11 at a position corresponding to the test strip analysis film 8. The upper case surface of the cartridge 3 is provided with a viewing window 12 at a position corresponding to the end point indicator label 10 of the test strip reaction. The cartridge 3 is provided with a storage medium 14.
The label pad 5 of the test strip 2 is coated with a single specific molecule related to detection of a target analyte labeled with a single label, or: and detecting a mixture of related specific molecules by using each target object correspondingly marked by different markers.
The test strip 2 may have one or more test strips 6 (shown in fig. 5 and 6) or strips 7 and 8. The detection zone 6 is coated with another specific molecule related to the detection of a target object, or: coated with a mixture of other specific molecules relevant for the detection of each target test substance.
The quality control strip 7 of the test strip 2 is coated with a quality control substance. The quality control substance comprises a secondary antibody.
The strip reaction endpoint indicator 10 includes, but is not limited to, a pH paper having a color change in the range of 5-9. During sample detection, the test strip reaction end point indicating label 10 on the test strip can be developed according to the pH condition of the test strip reaction to prompt whether the test strip reactant has sufficiently permeated through the detection zone 6 and the quality control zone 7 and prompt whether the test strip reaction is sufficient and whether the detection result is effective.
The storage medium 14 on the cartridge 3 includes, but is not limited to, an RFID tag, an IC chip, a magnetic code, a bar code, or the like. The storage medium 14 stores a standard curve or coefficient parameter of the detected object for quantifying the sample concentration of the same batch of test strips 2, a reference monitoring value of the signal intensity of the control band of the quality of the test strips, a batch number of the test strips, an expiration date of the test strips, a password of the storage medium, a reference value of clinical indexes, information of manufacturers of the test strips and the like, and can read information such as identity information, information of testers, sample names, sample numbers, detection dates, detection results and the like of the detected objects.
The standard curve of the object stored in the storage medium 14 has various forms, including but not limited to the following curves: concentration of standard substance series to be detectedA Detection belt/A Quality control bandThe corresponding relation curve between the two curves; or, the concentration of the standard substance series of the object to be tested andA detection belt/（A Detection belt+A Quality control band) The corresponding relation curve between the two. Wherein,A detection beltThe signal intensity of the detection zone measured for the series concentration of the object standard,A quality control bandAnd the signal intensity of the quality control band measured for the series concentration of the detected object standard.
The marking pad 5 of the test strip 2 is a glass fiber film; the analysis membrane 8 of the test strip 2 is a nitrocellulose membrane, a nylon membrane or a mixed membrane of nitrocellulose and cellulose acetate; the bottom liner 1 of the test strip 2 is made of polyester or a plastic plate; the cartridge 3 is made of polyester, plastic, rigid paper material, or other material.
The test strip 2 is any test strip including, but not limited to, quantum dot labeling test strips, colloidal gold labeling test strips, colloidal selenium labeling test strips, upconversion phosphor labeling test strips, nano rare earth fluorescent complex labeling test strips, nano magnetic particle labeling test strips, time-resolved chromatography test strips, and chemiluminescence test strips.
The strip 2 is a disposable item. The card box 3 and the storage medium 14 on the card box 3 are used as accessories for the test strips 2 in the same batch.
When the test strip card is used for detecting a sample, the test strip 2 is inserted into the card box 3 at present, and the interference extending end of the test strip 2 inserted into the card box 3 is soaked and absorbs the liquid sample. After the test strip reaction endpoint indication label 10 indicates that the chromatographic reaction of the sample on the test strip 2 is completed, collecting characteristic signals of a detection band 6 and a quality control band 7 of the test strip 2 by an instrument with a signal detection function (such as a strip reader, a fluorescence detector, a magnetic signal detector and the like) and quantitatively obtaining the single-component or multi-component concentration of the sample by combining with a standard curve or coefficient parameter of the detected object which is simultaneously read from a storage medium 14 of a test strip card by the instrument; or, after the test strip reaction end point indicator 10 indicates that the sample completes the test strip reaction on the test strip 2, the sample components are qualitatively or semi-quantitatively detected according to the display conditions of the test strip detection zone 6 and the quality control zone 7 of the test strip card.
The sample to be detected of the test strip card can be clinical or non-clinical blood, body fluid, urine, saliva, genital secretion or other liquid samples or viscous samples, wherein the clinical samples comprise samples of infectious diseases, hormones, cardiovascular diseases, tumors, cancers, diabetes, autoimmune diseases and the like, and the non-clinical samples comprise samples of food detection, environmental pollution detection, pesticide residue detection, biological contamination detection, biological agent detection, veterinary medicine detection, drug detection and the like.
It should be pointed out that the test strip card of the present invention can also have other improvements, for example, the storage medium 14 storing the information for detection such as the standard curve of the detected object can be directly installed on the test strip 2 in the test strip card besides being installed on the card box 3 of the test strip card; the test strip in the cartridge 3 can be expanded and replaced by a biochip (including antigen-antibody chip, protein chip, nucleic acid chip, microfluidic chip) and the like based on the same principle of the invention. Therefore, any other technical solutions formed by any equivalent replacement or equivalent transformation on the test strip card of the present invention fall within the protection scope of the claims of the present invention.
Claims (3)
1. The utility model provides a test strip card, includes card box (3) and test strip (2), test strip (2) including in order the overlap joint fix inhale appearance pad (4) on end liner (1), mark pad (5), analysis membrane (8), absorb water pad (9), analysis membrane (8) have test tape (6) and quality control area (7), test tape (6) are one or many, the last box face of card box (3) is opening corresponding to test strip analysis membrane (8) position department has detection window (11), its characterized in that:
one end of the card box (3) and an upper box surface opening of the card box end form a test strip slot opening (13), the test strip (2) is of an off-type plug-and-play structure of the card box (3), and when a sample is detected, one end of a sample absorbing pad (4) of the test strip (2) inserted into the card box (3) extends out of the opening end of the card box (3) in an interference manner so as to dip and absorb the sample;
the card box (3) is also provided with a storage medium (14);
the marking pad (5) of the test strip (2) is coated with a single marker-labeled single specific molecule related to detection of a certain target test object, or: a mixture of specific molecules related to detection of each target object coated with corresponding markers of different markers; the detection belt (6) of the test strip (2) is coated with another specific molecule related to the detection of a target detected object, or: a mixture coated with another specific molecule related to the detection of each target test substance; the quality control belt (7) of the test strip (2) is coated with a quality control substance comprising a secondary antibody;
the storage medium (14) on the card box (3) comprises an RFID label, an IC chip, a magnetic code or a bar code;
the storage medium (14) is stored with a detected object standard curve or coefficient parameter for quantifying the sample concentration of the test strip (2) in the same batch, a reference monitoring value of the signal intensity of a test strip quality control signal, a test strip batch number, a test strip validity period, a storage medium password, a clinical index reference value and test strip manufacturer information, and can read the identity information, the information of a detector, a sample name, a sample number, a detection date and detection result information of a detected object;
the standard curve of the detected object stored in the storage medium (14) has various forms which can be selected, and the standard curve comprises: concentration of standard substance series to be detectedA Detection belt/A Quality control bandThe corresponding relation curve between the two curves; or, the concentration of the standard substance series of the object to be tested andA detection belt/（A Detection belt+A Quality control band) The corresponding relation curve between the two curves; wherein,A detection beltThe signal intensity of the detection zone measured for the series concentration of the object standard,A quality control bandSignal intensity of quality control band measured for series concentration of detected object standard;
the marking pad (5) of the test strip (2) is a glass fiber film; the analysis membrane (8) of the test strip (2) is a nitrocellulose membrane, a nylon membrane or a mixed membrane of nitrocellulose and cellulose acetate; the bottom lining (1) of the test strip (2) is made of polyester or a plastic plate; the card box (3) is made of polyester, plastic or hard paper material;
the test strip (2) is any test strip, and comprises a quantum dot marking test strip, a colloidal gold marking test strip, a colloidal selenium marking test strip, an up-conversion phosphor marking test strip, a nano rare earth fluorescent complex marking test strip, a nano magnetic particle marking test strip, a time resolution chromatography test strip and a chemiluminescence test strip;
the test strips (2) are disposable articles, and the card box (3) and the storage medium (14) on the card box (3) are articles matched with the test strips (2) in the same batch;
when the sample is detected, the test strip (2) is currently inserted into the card box (3), the interference extending end of the test strip (2) inserted into the card box (3) is soaked to absorb the sample, after the sample completes the test strip reaction on the test strip (2), an instrument with a signal detection function collects characteristic signals of a detection belt (6) and a quality control belt (7) of the test strip (2) in the card box and combines a detected object standard curve or coefficient parameter which is simultaneously read from a storage medium (14) by the instrument to quantitatively obtain the single-component or multi-component concentration of the sample; or, during sample detection, the test strip (2) is inserted into the card box (3) at present, the interference extending end of the test strip (2) inserted into the card box (3) is soaked to absorb a sample, and after the sample completes test strip reaction on the test strip (2), the components of the sample are qualitatively or semi-quantitatively detected according to the display conditions of the test strip detection belt (6) and the quality control belt (7).
2. The test strip card of claim 1, wherein: wherein a test strip reaction end point indicating label (10) is lapped behind the water absorption pad (9) of the test strip (2); an observation window (12) is arranged at the corresponding position of the test strip reaction end point indication label (10) of the card box (3);
the test strip reaction end point indicator label (10) comprises pH test paper with the color change range of 5-9;
the marking pad (5) of the test strip (2) is coated with a single marker-labeled single specific molecule related to detection of a certain target test object, or: a mixture of specific molecules related to detection of each target object coated with corresponding markers of different markers; the detection belt (6) of the test strip (2) is coated with another specific molecule related to the detection of a target detected object, or: a mixture coated with another specific molecule related to the detection of each target test substance; the quality control belt (7) of the test strip (2) is coated with a quality control substance comprising a secondary antibody;
the storage medium (14) on the card box (3) comprises an RFID label, an IC chip, a magnetic code or a bar code;
the storage medium (14) is stored with a detected object standard curve or coefficient parameter for quantifying the sample concentration of the test strip (2) in the same batch, a reference monitoring value of the signal intensity of a test strip quality control signal, a test strip batch number, a test strip validity period, a storage medium password, a clinical index reference value and test strip manufacturer information, and can read the identity information, the information of a detector, a sample name, a sample number, a detection date and detection result information of a detected object;
the standard curve of the detected object stored in the storage medium (14) has various forms which can be selected, and the standard curve comprises: concentration of standard substance series to be detectedA Detection belt/A Quality control bandThe corresponding relation curve between the two curves; or, the concentration of the standard substance series of the object to be tested andA detection belt/（A Detection belt+A Quality control band) The corresponding relation curve between the two curves; wherein,A detection beltThe signal intensity of the detection zone measured for the series concentration of the object standard,A quality control bandSignal intensity of quality control band measured for series concentration of detected object standard;
the marking pad (5) of the test strip (2) is a glass fiber film; the analysis membrane (8) of the test strip (2) is a nitrocellulose membrane, a nylon membrane or a mixed membrane of nitrocellulose and cellulose acetate; the bottom lining (1) of the test strip (2) is made of polyester or a plastic plate; the card box (3) is made of polyester, plastic or hard paper material;
the test strip (2) is any test strip, and comprises a quantum dot marking test strip, a colloidal gold marking test strip, a colloidal selenium marking test strip, an up-conversion phosphor marking test strip, a nano rare earth fluorescent complex marking test strip, a nano magnetic particle marking test strip, a time resolution chromatography test strip and a chemiluminescence test strip;
the test strips (2) are disposable articles, and the card box (3) and the storage medium (14) on the card box (3) are articles matched with the test strips (2) in the same batch;
when the sample is detected, the test strip (2) is inserted into the card box (3) at present, the interference extending end of the test strip (2) inserted into the card box (3) is soaked to absorb the sample, the test strip reaction end point indication label (10) indicates that the sample completes the test strip reaction on the test strip (2), an instrument with a signal detection function is used for collecting characteristic signals of a detection band (6) and a quality control band (7) of the test strip (2) in the test strip card and combining with a standard curve or coefficient parameter of the detected object which is read by the instrument from a storage medium (14) simultaneously to obtain the single-component or multi-component concentration of the sample quantitatively; or, during sample detection, the test strip (2) is inserted into the card box (3) at present, the interference extending end of the test strip (2) inserted into the card box (3) is soaked to absorb a sample, and the test strip reaction endpoint indication label (10) indicates that the sample completes test strip reaction on the test strip (2), and then the components of the sample are detected qualitatively or semi-quantitatively according to the display conditions of the test strip detection belt (6) and the quality control belt (7).
3. The test strip card of claim 1 or 2, wherein: the sample to be detected is clinical or non-clinical blood, body fluid, urine, saliva, genital secretion or other liquid samples or viscous samples, wherein the clinical samples comprise samples of infectious diseases, hormones, cardiovascular diseases, tumors, cancers, diabetes and autoimmune diseases, and the non-clinical samples comprise samples of food detection, environmental pollution detection, pesticide residue detection, biological contamination detection, biological agent detection, veterinary medicine detection and drug detection.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310565273.6A CN103630685A (en) | 2013-11-13 | 2013-11-13 | Test strip card |
| PCT/CN2014/089646 WO2015070704A1 (en) | 2013-11-13 | 2014-10-28 | Test bar card |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310565273.6A CN103630685A (en) | 2013-11-13 | 2013-11-13 | Test strip card |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN103630685A true CN103630685A (en) | 2014-03-12 |
Family
ID=50211950
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201310565273.6A Pending CN103630685A (en) | 2013-11-13 | 2013-11-13 | Test strip card |
Country Status (2)
| Country | Link |
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| CN (1) | CN103630685A (en) |
| WO (1) | WO2015070704A1 (en) |
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Application publication date: 20140312 |