CN203759016U - Test strip card - Google Patents
Test strip card Download PDFInfo
- Publication number
- CN203759016U CN203759016U CN201320716462.4U CN201320716462U CN203759016U CN 203759016 U CN203759016 U CN 203759016U CN 201320716462 U CN201320716462 U CN 201320716462U CN 203759016 U CN203759016 U CN 203759016U
- Authority
- CN
- China
- Prior art keywords
- test strip
- card
- test
- sample
- detection
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
Links
- 238000012360 testing method Methods 0.000 title claims abstract description 276
- 238000001514 detection method Methods 0.000 claims abstract description 109
- 238000003908 quality control method Methods 0.000 claims abstract description 36
- 239000012528 membrane Substances 0.000 claims description 29
- 238000006243 chemical reaction Methods 0.000 claims description 28
- 210000004369 blood Anatomy 0.000 claims description 19
- 239000008280 blood Substances 0.000 claims description 19
- 238000004458 analytical method Methods 0.000 claims description 17
- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 claims description 14
- 239000002096 quantum dot Substances 0.000 claims description 11
- 229920000728 polyester Polymers 0.000 claims description 10
- 238000001914 filtration Methods 0.000 claims description 9
- 239000000463 material Substances 0.000 claims description 9
- 229920001220 nitrocellulos Polymers 0.000 claims description 7
- 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
- 238000004587 chromatography analysis Methods 0.000 claims description 5
- 239000003365 glass fiber Substances 0.000 claims description 5
- 239000006249 magnetic particle Substances 0.000 claims description 5
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 5
- 229910052761 rare earth metal Inorganic materials 0.000 claims description 4
- 150000002910 rare earth metals Chemical class 0.000 claims description 4
- 239000002250 absorbent Substances 0.000 claims description 3
- 230000002745 absorbent Effects 0.000 claims description 3
- 230000008859 change Effects 0.000 claims description 3
- 238000003745 diagnosis Methods 0.000 abstract description 2
- 238000000338 in vitro Methods 0.000 abstract description 2
- 230000035945 sensitivity Effects 0.000 abstract description 2
- 239000000126 substance Substances 0.000 description 18
- 239000000427 antigen Substances 0.000 description 14
- 102000036639 antigens Human genes 0.000 description 13
- 108091007433 antigens Proteins 0.000 description 13
- 210000003743 erythrocyte Anatomy 0.000 description 13
- 238000002372 labelling Methods 0.000 description 12
- 239000007788 liquid Substances 0.000 description 11
- 239000000203 mixture Substances 0.000 description 8
- 206010028980 Neoplasm Diseases 0.000 description 6
- 239000003814 drug Substances 0.000 description 6
- 238000005516 engineering process Methods 0.000 description 6
- 239000000020 Nitrocellulose Substances 0.000 description 5
- 239000003550 marker Substances 0.000 description 4
- 238000000034 method Methods 0.000 description 4
- 210000002966 serum Anatomy 0.000 description 4
- 208000023275 Autoimmune disease Diseases 0.000 description 3
- 208000024172 Cardiovascular disease Diseases 0.000 description 3
- 208000035473 Communicable disease Diseases 0.000 description 3
- 101100379079 Emericella variicolor andA gene Proteins 0.000 description 3
- 239000003124 biologic agent Substances 0.000 description 3
- 210000001124 body fluid Anatomy 0.000 description 3
- 239000010839 body fluid Substances 0.000 description 3
- 206010012601 diabetes mellitus Diseases 0.000 description 3
- 238000010586 diagram Methods 0.000 description 3
- 229940079593 drug Drugs 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 238000003912 environmental pollution Methods 0.000 description 3
- 210000004392 genitalia Anatomy 0.000 description 3
- 239000005556 hormone Substances 0.000 description 3
- 229940088597 hormone Drugs 0.000 description 3
- 238000003780 insertion Methods 0.000 description 3
- 230000037431 insertion Effects 0.000 description 3
- 238000012544 monitoring process Methods 0.000 description 3
- 239000000447 pesticide residue Substances 0.000 description 3
- 210000003296 saliva Anatomy 0.000 description 3
- 230000028327 secretion Effects 0.000 description 3
- 230000003595 spectral effect Effects 0.000 description 3
- 210000002700 urine Anatomy 0.000 description 3
- 239000012491 analyte Substances 0.000 description 2
- 239000003153 chemical reaction reagent Substances 0.000 description 2
- 239000011248 coating agent Substances 0.000 description 2
- 238000000576 coating method Methods 0.000 description 2
- 238000011109 contamination Methods 0.000 description 2
- 238000013508 migration Methods 0.000 description 2
- 230000005012 migration Effects 0.000 description 2
- 239000002245 particle Substances 0.000 description 2
- 238000001228 spectrum Methods 0.000 description 2
- 238000000018 DNA microarray Methods 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 238000003556 assay Methods 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 238000009739 binding Methods 0.000 description 1
- 201000011510 cancer Diseases 0.000 description 1
- 210000004027 cell Anatomy 0.000 description 1
- 238000004891 communication Methods 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 230000002255 enzymatic effect Effects 0.000 description 1
- 230000005284 excitation Effects 0.000 description 1
- 239000010931 gold Substances 0.000 description 1
- 229910052737 gold Inorganic materials 0.000 description 1
- 238000003018 immunoassay Methods 0.000 description 1
- 230000002779 inactivation Effects 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 102000039446 nucleic acids Human genes 0.000 description 1
- 108020004707 nucleic acids Proteins 0.000 description 1
- 150000007523 nucleic acids Chemical class 0.000 description 1
- 230000003287 optical effect Effects 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 102000004169 proteins and genes Human genes 0.000 description 1
- 108090000623 proteins and genes Proteins 0.000 description 1
- 238000012113 quantitative test Methods 0.000 description 1
- 239000000376 reactant Substances 0.000 description 1
- 239000004054 semiconductor nanocrystal Substances 0.000 description 1
- 238000012031 short term test Methods 0.000 description 1
- 230000001360 synchronised effect Effects 0.000 description 1
- 230000009466 transformation Effects 0.000 description 1
- SWGJCIMEBVHMTA-UHFFFAOYSA-K trisodium;6-oxido-4-sulfo-5-[(4-sulfonatonaphthalen-1-yl)diazenyl]naphthalene-2-sulfonate Chemical compound [Na+].[Na+].[Na+].C1=CC=C2C(N=NC3=C4C(=CC(=CC4=CC=C3O)S([O-])(=O)=O)S([O-])(=O)=O)=CC=C(S([O-])(=O)=O)C2=C1 SWGJCIMEBVHMTA-UHFFFAOYSA-K 0.000 description 1
Landscapes
- Investigating Or Analysing Materials By The Use Of Chemical Reactions (AREA)
Abstract
The utility model belongs to the field of in vitro diagnosis and in particular relates to a test strip card which can filter samples and is provided with a storage medium (15) for storing information for detection, such as standard curves or coefficient parameters and the like of detected objects. The test strip card comprises a card case (3) and a test strip (2), wherein an opening is formed at one end of the card case (3) to form a test strip slot (12); the test strip (2) is a separate immediately inserted structure of the card case (3); the storage medium (15) is installed on the card case (3). When samples are detected, one end of a sample sucking pad (4) of the test strip (2) inserted in the card case (3) extends out of the opening end of the card case (3) in an interference manner so as to soak and suck the samples, then an instrument with the signal detection function is used for collecting the characteristic signals of detection bands (7) and a quality control band (8) of the test strip (2) and standard curves or coefficient parameters of detected objects, which are simultaneously read by the instrument from the storage medium (15), are combined to obtain single-component or multicomponent concentrations of the samples. The test strip card has the characteristics of simplicity and quickness, high sensitivity, objective results, flexibility in use and the like when being used for detecting samples.
Description
Technical Field
The utility model belongs to the in vitro diagnosis field, concretely relates to can self filter the sample, have storage medium 15 from oneself and be equipped with the storage by detection such as object standard curve or coefficient parameter with information, combine the test strip card that the instrument that has the signal detection function can the short-term test sample single component or multicomponent.
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. However, the technology has the following defects:
(1) blood samples require instrumentation to separate the serum and do not allow the detection of whole blood samples. Because: red blood cells in a whole blood sample prevent the smooth migration of the reagent on the strip. ② the red cell color (red) is similar or same with the display color (light red or purple red) of the colloidal gold, which can interfere the judgment of the detection result. ③ erythrocytes interfere with many diagnostic assays, such as: in the detection of an analyte, the red blood cells may inhibit the combination between the paired components of the specific structure; erythrocytes have enzymatic activity that may interfere with the production of the detection signal. Utility model patent No. ZL03217482.9 discloses a technical scheme who establishes red blood cell filtration membrane adds between colloidal gold conjugate and nitrocellulose membrane of colloidal gold test paper strip in order to try to overcome the above-mentioned interference effect of red blood cell, and the not enough is: this technical measure is not overcome from the "source" component of the strip (the blotting pad 4), but instead, the red blood cell filtration membrane is introduced between the label pad 6 and the analysis membrane 9 of the colloidal gold test strip (i.e., between the "colloidal gold conjugate" and the nitrocellulose membrane of the test strip described in this patent). this "improved" solution for filtering red blood cells from the "downstream" component of the strip does not effectively overcome the interference of the binding reaction of red blood cells between the coating of the label pad 6 (gold label-antigen/antibody) and the target analyte from the blotting pad 4!
(2) Only can qualitatively detect the sample, can not carry out quantitative detection on the sample, and can not realize multi-component quantitative detection of the sample. The scheme disclosed in patent number ZL03217482.9 is the same as the prior art, and only the qualitative detection can be carried out on the sample, and the quantitative detection and the multi-component synchronous quantitative detection cannot be carried out on the sample.
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.
For overcoming prior art's not enough, the utility model provides an ability self filters the sample (when the sample is whole blood, can filter the erythrocyte), adopts and takes storage medium 15 to be equipped with the storage by the information for detection such as object standard curve or coefficient parameter (operating personnel need not make by object standard curve again when detecting the sample), combines the examination strip card that the instrument that has the signal detection function just can realize sample monocomponent or multicomponent ration (qualitative/semi-quantitative) detection fast. The utility model is used for sample detection has characteristics such as simple and convenient quick, sensitivity is high, the result is objective.
SUMMERY OF THE UTILITY MODEL
The utility model discloses technical scheme as follows:
the test strip card of the utility model comprises a card box 3 and a test strip 2. The test strip 2 comprises a sample absorbing pad 4, a filter pad 5, a marking pad 6, an analysis membrane 9 and a water absorbing pad 10 which are sequentially overlapped and fixed on the bottom lining 1. The analytical membrane 9 has a detection zone 7 and a quality control zone 8. The upper case surface of the cartridge 3 is opened with a detection window 13 at a position corresponding to the test strip analysis film 9. The card box 3 is provided with a storage medium 15 for storing information for testing samples by the test strips. One end of the cartridge 3, together with the upper cartridge face opening of the cartridge end, forms a test strip slot opening 12 to facilitate the insertion of the test strip 2 into the cartridge 3 at the present time. 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 open end of the card box 3 in an interference manner to soak and absorb the sample.
The filter pad 5 of the test strip 2 comprises a blood filtration membrane.
The marking pad 6 of the test strip 2 is coated with a single marker-labeled target test substance to detect a related single specific antigen (or antibody) molecule, or: the mixture of the related specific antigen (or antibody) molecules is detected by each target object correspondingly marked by different markers.
The test strip 2 may have one or more test strips 7. The detection band 7 is coated with a specific antibody (or antigen) molecule related to the detection of a target test object, or: coated with a mixture of specific antibody (or antigen) molecules relevant to the detection of each target test substance.
The quality control strip 8 of the test strip 2 is coated with a quality control substance. The quality control substance comprises a secondary antibody.
The storage medium 15 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 information for the test strip detection sample stored in the storage medium 15 includes a standard curve or coefficient parameter of the detected object for quantifying the sample concentration of the test strip 2 in the same batch, a reference monitoring value of the signal intensity of the control band of the test strip, a batch number of the test strip, an effective period of the test strip, a password of the storage medium, a reference value of a clinical index, information of a manufacturer of the test strip, and the like, and can be read into the information of the identity information, the information of a detector, the name of the sample, the number of the sample, the detection date, the detection.
The standard curve of the object stored in the storage medium 15 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 utility model discloses a examination strip reaction end point indication label 11 can also overlap joint after examination strip 2's absorbent pad 10. Accordingly, the cartridge 3 has a viewing window 14 corresponding to the test strip reaction endpoint indicator 11. The test strip reaction endpoint indicator label 11 includes, but is not limited to, a pH paper having a color change range of 5-9.
The marking pad 6 of the test strip 2 of the utility model is a glass fiber film; the analysis membrane 9 of the test strip 2 is a nitrocellulose membrane; 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.
Test strip 2 is any test strip, and it includes but not limited to quantum dot mark test strip, colloidal gold mark test strip, colloidal selenium mark test strip, up-conversion phosphor mark test strip, nanometer tombarthite fluorescence complex mark test strip, nanometer magnetic particle mark test strip, time resolution chromatography test strip, chemiluminescence test strip.
The utility model discloses examination strip 2 is disposable messenger's articles for use, card box 3 and the storage medium 15 on the card box 3 are the supporting articles for use of examination strip 2 of batch.
The examination strip card is when being used for the sample to examine, and examination strip 2 inserts card box 3 at present, and the interference of inserting examination strip 2 in card box 3 stretches out the end flooding and absorbs liquid sample. The liquid sample is pulled by the absorbent pad 10 at the other end of the test strip 2, and slowly migrates to the rear end of the test strip 2 by capillary siphoning of the microporous filter membrane (the liquid sample first reaches the standard marking pad 6 through the filter pad 5, and continuously migrates to the detection belt 7 and the quality control belt 8 of the analysis membrane 9 after being combined and reacted with the labeled conjugate of the marking pad 6) to complete the test strip reaction. During migration, the liquid sample is filtered in the filter pad region 5 behind the "source" component (the wicking pad 4) of the strip to avoid interference from interferents in the sample with the test strip detection reaction that is about to occur behind the filter pad 5. A typical example is that when the sample to be tested is a whole blood sample, the filter pad 5 of the test strip prevents red blood cells in the blood from passing through but only allows serum to filter, and the filter pad 5 plays a role in separating serum (the red blood cells can not only prevent the sample from smoothly permeating on the test strip 2, but also when the sample test adopts a colloidal gold test strip, the red color of the red blood cells can affect the authenticity and reliability of the test result due to the proximity to the red or purple color displayed by the colloidal gold marker on the test strip, when the test strip 2 is used for qualitative test of the sample, the observation and judgment of the test result can be affected, and when the test strip 2 is used for quantitative test of the sample, the optical density value accurately measured by the test instrument can be affected, so that the quantitative determination of the sample concentration is affected.
After the test strip reaction of the test strip card is finished by the tested object, the characteristic signals of a detection band 7 and a quality control band 8 of the test strip 2 in the test strip card 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 are combined with a tested object standard curve or coefficient parameter which is simultaneously read from a storage medium 15 by the instrument to quantitatively obtain the single-component or multi-component concentration of a sample; or, after the test strip card finishes the test strip reaction of the test strip object, the sample components are qualitatively or semi-quantitatively detected according to the display conditions of the test strip detection band 7 and the quality control band 8 of the test strip card.
The sample of examining of examination strip card can be the blood that comes from clinical or non-clinical, body fluid, urine, saliva, genital secretion or other liquid sample or thick consistency sample, wherein, clinical sample includes the sample including infectious disease, hormone, cardiovascular disease, tumour, cancer, diabetes, autoimmune disease etc. non-clinical sample includes the sample including food detection, environmental pollution detects, the pesticide residue detects, biological is infected with the detection, biological agent detects, veterinary medicine detects, drugs detect etc..
Compared with the prior art, the utility model discloses following beneficial effect has:
(1) when the test strip card is used for detecting a sample, the sample can be filtered, and the interference effect of the components influenced by the sample detection is reduced. Such as: when the sample to be detected is a whole blood sample, the whole blood can be directly used for detection. When the existing test strip technology is used for detecting a blood sample, instrument equipment such as a centrifugal machine, a centrifugal tube and the like is needed to be used for separating serum firstly and then detecting the blood sample, so that the whole blood sample cannot be detected.
(2) The sample components can be detected rapidly and quantitatively (including qualitative or semi-quantitative detection of the sample components). Install storage medium 15 on the test strip card, this storage medium 15 stores and is detected information for detection such as object standard curve or coefficient parameter. After the chromatographic reaction of the sample to be detected on the test strip is completed, the instrument with the signal detection function collects the characteristic signals of the detection band 7 and the quality control band 8 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 15 by the instrument, so that the component concentration of the sample can be rapidly and quantitatively obtained within minutes. The prior test strip technology does not have the function.
(3) Examination strip 2 in the examination strip card can realize the quick accurate quantitative determination of multicomponent of sample simultaneously when adopting the quantum dot mark. 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. Adopt different quantum dots to mark the corresponding antigen/antibody reaction molecule of the detected object respectively, be in its mixture coating the utility model the examination strip of the examination strip card is reacted with the sample to be detected, through determining the specific fluorescence signal of examination strip, just can be fast accurate quantitative sample multicomponent concentration in a few minutes. The existing test strip technology can only qualitatively detect samples, cannot realize quantitative detection of the samples, and cannot realize multi-component quantitative detection of the samples.
(4) 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 utility model discloses a overlook structure chart of examination strip card preferred scheme one (show that its interior examination strip 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 utility model discloses a overlook structure chart of examination strip card preferred scheme one (show that its interior examination strip adopts many detection lines)
FIG. 4: side view structure diagram of test strip in card box (the test strip adopts many detection lines)
FIG. 5: the overlook structure chart of another preferred scheme of the test strip card of the utility model (the test strip in the test strip card adopts a detection line)
FIG. 6: the side view structure chart of the test strip in the card box of another preferred scheme of the test strip card (the test strip adopts a detection line)
FIG. 7: the overlook structure chart of another preferred scheme of the test strip card of the utility model (the test strip in the test strip card adopts a plurality of detection lines)
FIG. 8: side view structure diagram of test strip in card box of another preferred scheme of test strip card (the test strip adopts many detection lines)
The sequence numbers are as follows:
1. bottom lining, 2, test strip, 3, card box, 4, sample sucking pad, 5, filter pad, 6, marking pad, 7, detection band, 8, quality control band, 9, analysis film, 10, water absorption pad, 11, test strip reaction end point indication label, 12, test strip socket opening, 13, detection window, 14, observation window, 15 and storage medium
Detailed Description
The following examples and drawings are only intended to illustrate the present invention further, and those skilled in the art should not be construed as limiting the scope of the present invention.
Example one
Fig. 1-4 illustrate a first embodiment. The first embodiment is one of the preferred embodiments 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 filter pad 5, a marking pad 6, an analysis membrane 9 and a water absorbing pad 10 which are sequentially overlapped and fixed on the bottom lining 1. The analytical membrane 9 has a detection zone 7 and a quality control zone 8. The upper case surface of the cartridge 3 is opened with a detection window 13 at a position corresponding to the test strip analysis film 9. The card box 3 is provided with a storage medium 15 for storing information for testing samples by the test strips. One end of the cartridge 3, together with the upper cartridge face opening of the cartridge end, forms a test strip slot opening 12 to facilitate the insertion of the test strip 2 into the cartridge 3 at the present time. 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 filter pad 5 of the test strip 2 comprises a blood filtration membrane.
The marking pad 6 of the test strip 2 is coated with a single marker-labeled target test substance to detect a related single specific antigen (or antibody) molecule, or: the mixture of the related specific antigen (or antibody) molecules is detected by each target object correspondingly marked by different markers.
The test strip 2 may have one or more test strips 7 (shown in fig. 1 and 2) or a plurality of test strips 7 (shown in fig. 3 and 4). The detection band 7 is coated with a specific antibody (or antigen) molecule related to the detection of a target test object, or: coated with a mixture of specific antibody (or antigen) molecules relevant to the detection of each target test substance.
The quality control strip 8 of the test strip 2 is coated with a quality control substance. The quality control substance comprises a secondary antibody.
The storage medium 15 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 information for the test strip detection sample stored in the storage medium 15 includes a standard curve or coefficient parameter of the detected object for quantifying the sample concentration of the test strip 2 in the same batch, a reference monitoring value of the signal intensity of the control band of the test strip, a batch number of the test strip, an effective period of the test strip, a password of the storage medium, a reference value of a clinical index, information of a manufacturer of the test strip, and the like, and can be read into the information of the identity information, the information of a detector, the name of the sample, the number of the sample, the detection date, the detection.
The standard curve of the object stored in the storage medium 15 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 6 of the test strip 2 is a glass fiber membrane; the analysis membrane 9 of the test strip 2 is a nitrocellulose membrane; 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 15 on the card box 3 are used as matching articles 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 finishes the test strip reaction on the test strip 2, acquiring characteristic signals of a detection band 7 and a quality control band 8 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 a detected object which is simultaneously read from a test strip card storage medium 15 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 band 7 and the quality control band 8 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 filter pad 5, a marking pad 6, an analysis membrane 9, a water absorbing pad 10 and a test strip reaction endpoint indicating label 11 which are sequentially overlapped and fixed on the bottom lining 1. The analytical membrane 9 has a detection zone 7 and a quality control zone 8. The upper case surface of the cartridge 3 is opened with a detection window 13 at a position corresponding to the test strip analysis film 9. The upper face of the cartridge 3 is provided with a viewing window 14 at a position corresponding to the end point indicator label 11 of the test strip reaction. The card box 3 is provided with a storage medium 15 for storing information for testing samples by the test strips. One end of the cartridge 3, together with the upper cartridge face opening of the cartridge end, forms a test strip slot opening 12 to facilitate the insertion of the test strip 2 into the cartridge 3 at the present time. 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 open end of the card box 3 in an interference manner to soak and absorb the sample.
The filter pad 5 of the test strip 2 comprises a blood filtration membrane.
The marking pad 6 of the test strip 2 is coated with a single marker-labeled target test substance to detect a related single specific antigen (or antibody) molecule, or: the mixture of the related specific antigen (or antibody) molecules is detected by each target object correspondingly marked by different markers.
The test strip 2 may have one or more test strips 7 (shown in fig. 5 and 6) or strips 7 (shown in fig. 7 and 8). The detection band 7 is coated with a specific antibody (or antigen) molecule related to the detection of a target test object, or: coated with a mixture of specific antibody (or antigen) molecules relevant to the detection of each target test substance.
The quality control strip 8 of the test strip 2 is coated with a quality control substance. The quality control substance comprises a secondary antibody.
The test strip reaction endpoint indicator label 11 includes, but is not limited to, a pH paper having a color change range of 5-9. During sample detection, the test strip reaction end point indicating label 11 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 7 and the quality control zone 8 or not, so as to prompt whether the test strip reaction is sufficient or not and whether the detection result is effective or not.
The storage medium 15 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 information for the test strip detection sample stored in the storage medium 15 includes a standard curve or coefficient parameter of the detected object for quantifying the sample concentration of the test strip 2 in the same batch, a reference monitoring value of the signal intensity of the control band of the test strip, a batch number of the test strip, an effective period of the test strip, a password of the storage medium, a reference value of a clinical index, information of a manufacturer of the test strip, and the like, and can be read into the information of the identity information, the information of a detector, the name of the sample, the number of the sample, the detection date, the detection.
The standard curve of the object stored in the storage medium 15 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 6 of the test strip 2 is a glass fiber membrane; the analysis membrane 9 of the test strip 2 is a nitrocellulose membrane; 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 15 on the card box 3 are used as matching articles 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 11 indicates that the sample completes the test strip reaction on the test strip 2, an instrument with a signal detection function (such as a strip reader, a fluorescence detector, a magnetic signal detector and the like) collects characteristic signals of a detection band 7 and a quality control band 8 of the test strip 2 in the test strip card and quantitatively obtains the single-component or multi-component concentration of the sample by combining with a standard curve or coefficient parameter of a detected object which is simultaneously read from a storage medium 15 of the test strip card by the instrument; or, after the test strip reaction end point indicator 11 indicates that the test strip reaction of the sample on the test strip 2 is completed, the sample components are qualitatively or semi-quantitatively detected according to the display conditions of the test strip detection band 7 and the quality control band 8 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 15 storing the information for detection such as the standard curve of the detected object is installed on the test strip card 2 in the test strip card besides the card box 3 of the test strip card; based on the same principle of the utility model, the test strip in the card box 3 can be expanded and replaced by a biochip (including an antigen-antibody chip, a protein chip, a nucleic acid chip and a microfluidic chip) and the like. Therefore, any other technical solutions that are formed by adopting any equivalent replacement or equivalent transformation to the test strip card of the present invention all fall within the protection scope of the claims of the present invention.
Claims (11)
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 (6), analysis membrane (9), absorb water pad (10), analysis membrane (9) have test tape (7) and quality control area (8), test tape (7) are one or more, the last box face of card box (3) is being opened corresponding to test strip analysis membrane (9) position department has detection window (13), 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 (12), the test strip (2) is of an off-type plug-and-play structure of the card box (3), and 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 to dip and absorb a sample;
the card box (3) is also provided with a storage medium (15) for storing information for detecting a sample by the test strip;
and a filter pad (5) for filtering the sample is connected between the sample sucking pad (4) and the marking pad (6) of the test strip.
2. The test strip card of claim 1, wherein: the storage medium (15) on the card box (3) comprises an RFID label, an IC chip, a magnetic code or a bar code.
3. The test strip card of claim 1, wherein: the filter pad (5) of the test strip comprises a blood filtration membrane.
4. The test strip card of claim 1, wherein: the test strip is characterized in that a marking pad (6) of the test strip (2) is a glass fiber film, an analysis film (9) of the test strip (2) is a nitrocellulose film, a bottom liner (1) of the test strip (2) is made of polyester or a plastic plate, and the card box (3) is made of polyester, plastic or a hard paper material.
5. The test strip card of claim 1, wherein: the test strips (2) are quantum dot mark test strips, colloidal gold mark test strips, colloidal selenium mark test strips, up-conversion phosphor mark test strips, nano rare earth fluorescent complex mark test strips, nano magnetic particle mark test strips, time resolution chromatography test strips and chemiluminescence test strips.
6. The test strip card of claim 1, wherein: wherein a test strip reaction end point indicating label (11) is lapped behind the absorbent pad (10) of the test strip (2); the corresponding position of the test strip reaction end point indicator label (11) of the card box (3) is provided with a viewing window (14).
7. The test strip card of claim 6, wherein the test strip reaction endpoint indicator label (11) comprises a pH paper having a color change range of 5-9.
8. The test strip card of claim 6, wherein: the storage medium (15) on the card box (3) comprises an RFID label, an IC chip, a magnetic code or a bar code.
9. The test strip card of claim 6, wherein: the filter pad (5) of the test strip (2) comprises a blood filtration membrane.
10. The test strip card of claim 6, wherein: the test strip is characterized in that a marking pad (6) of the test strip (2) is a glass fiber film, an analysis film (9) of the test strip (2) is a nitrocellulose film, a bottom liner (1) of the test strip (2) is made of polyester or a plastic plate, and the card box (3) is made of polyester, plastic or a hard paper material.
11. The test strip card of claim 6, wherein: the test strips (2) are quantum dot mark test strips, colloidal gold mark test strips, colloidal selenium mark test strips, up-conversion phosphor mark test strips, nano rare earth fluorescent complex mark test strips, nano magnetic particle mark test strips, time resolution chromatography test strips and chemiluminescence test strips.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201320716462.4U CN203759016U (en) | 2013-11-13 | 2013-11-13 | Test strip card |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201320716462.4U CN203759016U (en) | 2013-11-13 | 2013-11-13 | Test strip card |
Publications (1)
Publication Number | Publication Date |
---|---|
CN203759016U true CN203759016U (en) | 2014-08-06 |
Family
ID=51254272
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN201320716462.4U Expired - Fee Related CN203759016U (en) | 2013-11-13 | 2013-11-13 | Test strip card |
Country Status (1)
Country | Link |
---|---|
CN (1) | CN203759016U (en) |
Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN103645311A (en) * | 2013-11-13 | 2014-03-19 | 成都领御生物技术有限公司 | Test strip card |
WO2015070700A1 (en) * | 2013-11-12 | 2015-05-21 | 成都领御生物技术有限公司 | Quantum dot-labeled test strip card |
WO2015070750A1 (en) * | 2013-11-16 | 2015-05-21 | 成都领御生物技术有限公司 | Test strip card |
WO2015070748A1 (en) * | 2013-11-15 | 2015-05-21 | 成都领御生物技术有限公司 | Test strip card |
WO2015070704A1 (en) * | 2013-11-13 | 2015-05-21 | 成都领御生物技术有限公司 | Test bar card |
-
2013
- 2013-11-13 CN CN201320716462.4U patent/CN203759016U/en not_active Expired - Fee Related
Cited By (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2015070700A1 (en) * | 2013-11-12 | 2015-05-21 | 成都领御生物技术有限公司 | Quantum dot-labeled test strip card |
CN103645311A (en) * | 2013-11-13 | 2014-03-19 | 成都领御生物技术有限公司 | Test strip card |
WO2015070702A1 (en) * | 2013-11-13 | 2015-05-21 | 成都领御生物技术有限公司 | Test strip card |
WO2015070704A1 (en) * | 2013-11-13 | 2015-05-21 | 成都领御生物技术有限公司 | Test bar card |
WO2015070748A1 (en) * | 2013-11-15 | 2015-05-21 | 成都领御生物技术有限公司 | Test strip card |
WO2015070750A1 (en) * | 2013-11-16 | 2015-05-21 | 成都领御生物技术有限公司 | Test strip card |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
CN203759017U (en) | Test strip card | |
CN103645311A (en) | Test strip card | |
WO2015070701A1 (en) | Test strip card | |
CN203759015U (en) | Test strip card | |
CN103675268A (en) | Test strip card | |
WO2015070748A1 (en) | Test strip card | |
CN203759014U (en) | Test strip card | |
WO2015070704A1 (en) | Test bar card | |
CN203759016U (en) | Test strip card | |
US8470608B2 (en) | Combined visual/fluorescence analyte detection test | |
WO2015070750A1 (en) | Test strip card | |
JP2015522801A (en) | Clinical diagnostic system | |
WO2015070745A1 (en) | Test strip card marked by quantum dots | |
WO2015070699A1 (en) | Quantum dot-labeled test strip card | |
WO2015070700A1 (en) | Quantum dot-labeled test strip card | |
WO2015070749A1 (en) | Test strip card | |
CN201535776U (en) | Quantitative detection system based on test strip marked with constantly illuminating material | |
CN203759009U (en) | Quantum dot labeled test strip card | |
US20230131712A1 (en) | Blood volume measurement with fluorescent dye | |
WO2015070746A1 (en) | Test strip card marked by quantum dots | |
WO2015070703A1 (en) | Test strip card | |
CN103645314A (en) | Test strip card capable of automatically filtering sample | |
CN203759013U (en) | Test strip card | |
CN203606364U (en) | Test strip card | |
CN203759018U (en) | Test strip card |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
C14 | Grant of patent or utility model | ||
GR01 | Patent grant | ||
CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20140806 |
|
CF01 | Termination of patent right due to non-payment of annual fee |