WO2015070700A1 - Carte de bande d'essai marquée par des points quantiques - Google Patents

Carte de bande d'essai marquée par des points quantiques Download PDF

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Publication number
WO2015070700A1
WO2015070700A1 PCT/CN2014/089565 CN2014089565W WO2015070700A1 WO 2015070700 A1 WO2015070700 A1 WO 2015070700A1 CN 2014089565 W CN2014089565 W CN 2014089565W WO 2015070700 A1 WO2015070700 A1 WO 2015070700A1
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Prior art keywords
test strip
quantum dot
sample
strip
cds
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PCT/CN2014/089565
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English (en)
Chinese (zh)
Inventor
马义才
顾敏
马灵
Original Assignee
成都领御生物技术有限公司
马义才
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Application filed by 成都领御生物技术有限公司, 马义才 filed Critical 成都领御生物技术有限公司
Publication of WO2015070700A1 publication Critical patent/WO2015070700A1/fr

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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
    • 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
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366—Apparatus specially adapted for solid-phase testing
    • G01N33/54386—Analytical elements
    • G01N33/54387—Immunochromatographic test strips
    • G01N33/54388—Immunochromatographic test strips based on lateral flow
    • 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

Definitions

  • the invention belongs to the field of in-vitro diagnosis, and particularly relates to a quantum dot mark capable of rapidly quantifying a single component or a multi-component concentration of a sample by combining an instrument with a test standard curve or a coefficient parameter and the like, and an instrument having a signal detection function.
  • Test strip card
  • GICA Gold-Immunochromatography Assay
  • nano quantum dots have unique and excellent optical properties: high fluorescence efficiency, wide excitation line range, single-element excitation, multiple emission, narrow emission spectrum and symmetry, and slow photobleaching speed.
  • the fluorescence lifetime is long, the particle size is similar to that of biomolecules, and the surface modification can be multi-functionalized.
  • the characteristic wavelength fluorescence spectra produced by the mixture of quantum dots of different particle sizes and kinds do not overlap, which is very suitable for sample multi-component analysis. Sweeny et al.
  • Goldman's group used multicolor quantum dots to simultaneously detect enterotoxin B and 2,4,6-trinitrotoluene produced by staphylococci and four toxins of cholera toxin, ricin, Shiga toxin and staphylococcal toxin.
  • quantum dots are used as fluorescent labels in microfluidic protein chips, and their fluorescent pleochroism can simultaneously detect tumor markers carcinoembryonic antigen (CEA) and alpha-fetoprotein (AFP) with detection limits as low as 250fmol. /L, 4 orders of magnitude higher than detection with organic fluorescent dyes.
  • CEA carcinoembryonic antigen
  • AFP alpha-fetoprotein
  • VEGFA vascular endothelial growth factor A
  • angiopoietin angiopoietin
  • quantum dots of different emission wavelengths to form fluorescent probes, which caused aggregation of quantum dots by antigen-antibody specific binding reaction, and quantified by flow cytometry.
  • the characteristic fluorescent signal was detected to obtain the concentration of the corresponding antigen, and the detection limit was 1 pmol/L, and simultaneous detection of various antigens was achieved.
  • quantum dot coding to perform multi-component analysis. This technology is mainly encoded by the richness of quantum dot fluorescence color and fluorescence intensity. It can simultaneously measure more components and achieve simultaneous analysis of massive information in protein analysis, DNA analysis and drug screening. .
  • n kinds of intensity m colors can generate n m -1 kinds of codes, and the detection and detection of n m -1 kinds of targets can be realized by decoding technology.
  • the calculation only 50,000 to 40,000 identifiable nanoparticle-encoded microspheres can be obtained by combining 5 to 6 colors with 6 quantum dots of different luminescence intensity. If combined with 10 quantum-intensity quantum dot nanoparticles, one million identifiable nanoparticle-encoded microspheres can be obtained. These microspheres can theoretically encode 1 million different DNA or proteins. Simultaneous detection of 1 million different DNAs or proteins in a sample! Nie et al.
  • Wilson and Cooper used this technology to achieve three serum proteins (chicken ovalbumin OVA, bovine serum albumin BSA, human serum albumin HAS) and four immunoglobulin G (human IgG, rabbit IgG, murine IgG, sheep). Simultaneous detection of IgG).
  • Chinese Patent Application No. 200610024086.7 discloses a method for detecting a quantum dot-labeled rapid immunochromatographic test strip.
  • the patent enables multi-component simultaneous detection, it is a method that is claimed, and no request for protection of a quantum dot-labeled rapid immunochromatographic test strip product has been proposed.
  • this method has some shortcomings: (1) To achieve multi-component detection of samples, it is necessary to simultaneously set a plurality of corresponding detection lines on the analysis membrane, that is, each detection line is only used to detect one index in the sample, and the detection efficiency is low.
  • the detector wants to simultaneously detect a large number of components, flux components, and even large components in the sample, it is impossible for a small test strip to achieve the detection target by setting such a large number of corresponding detection lines.
  • Quantifying the concentration of the test substance using the standard curve of the test subject standard is the main method for quantifying the concentration of the sample in the field of detection.
  • Recently developed storage media in the information field such as RFID tags (also known as radio frequency identification tags), IC chips, magnetic codes, barcodes, etc., for information access identification is now widely used in computers, communications, electronics, commerce, transportation Control management and other fields, especially RFID tags, small size, large storage information capacity, identification without manual intervention, is an ideal means of information access identification, but few people currently use it for biomedical testing.
  • the present invention is directed to the deficiencies and shortcomings of the prior art, and provides a quantum dot marking test strip card on which a storage medium 14 is mounted.
  • the storage medium 14 stores the same batch of quantum dot marking strips 2 for quantitative detection of the detected object.
  • Information for testing such as standard curve or coefficient parameters for concentration.
  • the characteristic signal of the test strip 2 test strip 6 and the quality control strip 7 in the test strip card cartridge 3 is collected by the instrument having the signal detecting function and combined with the instrument from the storage medium 14
  • the single-component or multi-component concentration of the sample is calculated by simultaneously reading the sample standard curve or coefficient parameter.
  • the invention is characterized in that the sample concentration, in particular the multi-component concentration of the sample, is simple, rapid, sensitive, objective, and flexible.
  • the quantum dot-labeled test strip card of the present invention comprises a cartridge 3 and a quantum dot marking strip 2.
  • the quantum dot marking test strip 2 includes a sample pad 4, a marking pad 5, an analysis film 8, and an absorbent pad 9 which are sequentially attached to the substrate 1 by overlapping.
  • the analysis membrane 8 has a detection strip 6 and a quality control strip 7.
  • One end of the cartridge 3 and the upper opening of the cartridge end form a test strip slot 13 to facilitate the insertion of the quantum dot marking strip 2 into the cartridge 3.
  • the test strip 2 is a separate insertion structure of the cartridge 3. At the time of sample detection, the test strip 2 inserted into the cartridge 3 has one end of the sample pad 4 interfering with the open end of the cartridge 3 to be immersed to suck the sample.
  • the upper casing of the cartridge 3 is provided with a detection window 11 at a position corresponding to the test strip analysis film 8.
  • a storage medium 14 is mounted on the cartridge 3.
  • the marking pad 5 of the quantum dot marking strip 2 is coated with a single specific molecule related to a target detection of a single quantum dot label, or: a target analyte coated with a label corresponding to a single quantum dot A mixture of related specific molecules is detected.
  • the single quantum dots coated by the marking pad 5 include ZnS, CdS, HgS, ZnSe, CdSe, HgSe, CdTe, ZnTe, ZnO, PbSe, HgTe, CaAs, InP, InAs, InCaAs, CdS/ZnS, CdS/Ag 2 S, CdS/PbS, CdS/Cd(0H) 2 , CdS/HgS, CdS/HgS/CdS, ZnS/CdS, ZnS/CdS/ZnS, ZnS/HgS/ZnS/CdS, CdSe/CdS, CdSe/ZnS, CdSe/ZnSe, CdSe/CuSe, CdSe/HgTe, CdSe/HgSe, CdSe/HgSe/CdSe, CdTe/HgS,
  • the detection band 6 of the quantum dot marking strip 2 may be one piece or a plurality of pieces.
  • the test strip 6 is coated with another specific molecule associated with detection of a target analyte, or a mixture of another specific molecule coated with detection of each target analyte.
  • the quality control strip 7 of the quantum dot marking strip 2 is coated with a quality control.
  • the control includes a secondary antibody.
  • the storage medium 14 includes, but is not limited to, an RFID tag, an IC chip, a magnetic code, or a barcode.
  • the storage medium 14 stores the standard curve or coefficient parameter of the sample for quantitative sample concentration of the same batch of quantum dot labeling strip 2, the reference density control strip optical density reference monitoring value, the test strip batch number, the test strip validity period, and the storage Storage medium password, clinical index reference value, test strip manufacturer information, etc., and can read information such as the identity information of the test object, the tester information, the sample name, the sample number, the test date, and the test result.
  • the standard curve of the object stored in the storage medium 14 can be selected in various forms, including but not limited to the following curve: the correspondence between the concentration of the standard sample of the object to be tested and the OD detection zone /OD control zone Relationship curve; or, the corresponding relationship between the concentration of the sample standard series and the OD detection zone / (OD detection zone + OD quality control zone ).
  • the OD detection zone is the optical density value of the detection zone measured by the concentration of the standard sample of the test object
  • the OD quality control zone is the optical density value of the quality control zone measured by the concentration of the standard sample of the test object.
  • a test strip reaction end point indicating label 10 can be overlapped.
  • the test strip reaction end point of the cartridge 3 indicates that the label 10 has a viewing window 12 corresponding thereto.
  • the strip reaction end point indicator 10 includes a pH test strip having a discoloration range of 5-9.
  • the marking pad 5 of the quantum dot marking strip 2 of the present invention is a glass fiber membrane; the analysis membrane 8 of the quantum dot marking strip 2 is a nitrocellulose membrane, a nylon membrane, or a nitrocellulose/cellulose acetate mixed membrane.
  • the underlayer 1 of the quantum dot marking strip 2 is a polyester or plastic plate; the cartridge 3 is made of polyester, plastic, hard paper material, or other material.
  • the quantum dot marking test strip 2 of the present invention is a disposable product, and the storage medium 14 on the cartridge 3 and the cartridge 3 is a used product matched with the same batch of quantum dot marking test strips 2.
  • the quantum dot marking strip card of the present invention When the quantum dot marking strip card of the present invention is used for sample detection, the quantum dot marking strip 2 is currently inserted into the cartridge 3, and the interference protruding end of the strip 2 inserted into the cartridge 3 is immersed in the liquid. sample.
  • the liquid sample is tested on test strip 2
  • the characteristic signals of the test strip 2 detection strip 6 and the quality control strip 7 are collected by an instrument having a signal detecting function (such as a reading strip meter, a fluorescence detector, etc.) and combined with the apparatus from the strip card storage medium 14 simultaneously
  • the sample standard curve or coefficient parameter is read to calculate the single component or multi-component concentration of the sample.
  • the sample to be tested of the quantum dot-labeled test strip card of the present invention may be from clinical or non-clinical blood, body fluid, urine, saliva, genital tract secretion or other liquid sample or viscous sample, wherein the clinical sample includes Samples of infectious diseases, hormones, cardiovascular diseases, tumors, cancer, diabetes, autoimmune diseases, etc., non-clinical samples including food testing, environmental pollution testing, pesticide residue testing, biological contamination testing, biological agent testing, veterinary medicine Samples such as testing, drug testing, etc.
  • the present invention has the following beneficial effects:
  • the test strip card combined with the instrument with signal detection function can realize synchronous multi-component rapid quantitative detection (including qualitative detection).
  • Quantum dots of different particle sizes, types and structures can produce continuous fluorescence with different characteristic wavelengths, and the characteristic wavelength fluorescence peak spectra generated by the quantum dot mixture do not overlap.
  • the present invention uses different quantum dots to respectively mark the corresponding reaction molecules of the analyte, and mixes the same. The coating is reacted with the sample to be tested on the test strip 2 of the test strip card, and the characteristic fluorescent signal of the test strip 2 is measured, thereby enabling rapid quantification of the multi-component concentration of the sample.
  • the time for testing the sample is short, and the result can be obtained in a few minutes.
  • the quantitative sample concentration of the present invention requires the operator to prepare a standard curve of the test object, and the test information such as the standard curve or the coefficient parameter of the test object is stored on the storage medium 14.
  • the operator only needs to put the test strip to which the sample is applied to be completed after the test strip reaction, and then put the instrument with the signal detection function, and collect the characteristics of the strip 2 and the control strip 7 of the test strip 2 by the instrument.
  • the fluorescence signal combined with the corresponding test standard curve or coefficient parameter read from the storage medium 14 by the instrument, can quantitatively obtain the sample detection result in a few minutes.
  • the invention is based on the optical density ratio of the test strip and the quality control strip (OD detection strip /OD quality control strip or OD detection strip /(OD detection strip + OD quality control strip )) or coefficient parameter, and combined with the storage medium 14
  • the stored standard curve of the test object is analyzed by an instrument having a signal detecting function (such as a reading instrument, a fluorescence detector, etc.) to determine the concentration of the test object.
  • the storage medium 14 also stores a quality control band optical density reference monitoring value (OD quality control band ) of the sample standard at the time of preparation of the standard curve.
  • the quality control band optical density value (OD control band ) obtained by the test process and the quality control band optical density reference monitoring value (OD control band ) stored in the storage medium 14 are extremely statistically significant. Error, suggesting that the test strip failed.
  • the standard curve and the OD quality control tape on the storage medium 14 are matched with the test strip 2 in the test strip card to overcome the difference in the detection concentration of the test object which may be caused by the batch quality difference in the test strip built-in test strip 2.
  • the tail end of the test strip 2 of the present invention may further be provided with a test strip reaction end point indicating label 10 for indicating whether the reactants on the 2 of the apparatus used before the test strip 2 have been sufficiently oozing to the test strip.
  • the detection belt 6 and the quality control belt 7 are adapted to automatically scan the strip detection strip 6 and the quality control strip 7 to achieve the details of the success or failure of the dynamic monitoring strip chromatography reaction process.
  • the multi-indicator synchronous control is adopted to make the sample quantification more precise: 1
  • the control strip 7 is set on the test strip 2, and the optical density intensity is used for detecting and controlling.
  • the storage medium 14 stores a standard curve or coefficient parameter of the corresponding object for quantifying the concentration of the corresponding object.
  • the storage medium 14 stores the optical density reference monitoring value (OD quality control zone ) of the test strip quality control strip , and is used for monitoring whether the test strip reaction in the sample detection is established and prompting whether the detection result is valid.
  • 4 Set the test strip reaction end indication label on the test strip 2 to indicate whether the siphon bleed chromatography of the strip reaction reagent on the test strip is sufficient and whether the reaction reaches the end point.
  • the test strip 2 in the test strip card cartridge 3 is a one-time use test strip; the test strip card cassette 3 and the cartridge 3 for the current insertion of the disposable test strip 2 are stored.
  • the storage medium 14 is a used product matched with the test strip 2 of the batch.
  • the same batch test strip 2 can take the test strip card box 3 which is continuously matched with the same batch test strip 2 to carry out sample detection.
  • the test strip 2 is inexpensive and can be tolerated by ordinary consumers.
  • the sample dosage is small, and a few microliters to several tens of microliters can meet the detection needs.
  • the reagents and materials in the test strip are not involved in activity inactivation and can be stored at room temperature for a long time.
  • Figure 1 is a top plan view of a preferred embodiment of the quantum dot-labeled test strip card of the present invention (in which a test strip is used as a test line)
  • Figure 2 The preferred embodiment of the quantum dot-labeled test strip card of the present invention is a side view of the inserted test strip (the test strip uses a test line)
  • Figure 3 is a top plan view of a preferred embodiment of the quantum dot-labeled test strip card of the present invention (in which a plurality of test lines are used for inserting test strips)
  • Figure 4 is a side view structural view of a preferred embodiment of the quantum dot-labeled test strip card of the present invention, which is a matching test strip (the test strip uses a plurality of test lines)
  • Figure 5 is a top plan view of another preferred embodiment of the quantum dot-labeled test strip card of the present invention (in which a plug-in test strip adopts a test line)
  • Figure 6 is a side view structural view of a plug-in test strip of another preferred embodiment of the quantum dot-labeled test strip card of the present invention (the test strip adopts a test line)
  • Figure 7 is a top plan view of another preferred embodiment of the quantum dot-labeled test strip card of the present invention (in which a plurality of test lines are used for inserting test strips)
  • Figure 8 is a side view structural view of a plug-in test strip of another preferred embodiment of the quantum dot-labeled test strip card of the present invention (the test strip uses a plurality of test lines)
  • test strip 1, underlay, 2, test strip, 3, card box, 4, suction pad, 5, marking pad, 6, detection tape, 7, quality control tape, 8, analysis film, 9, absorbent pad, 10, test Strip reaction end indication label, 11, detection window, 12, observation window, 13, test strip slot, 14, storage medium.
  • Embodiment 1 is one of the preferred embodiments of the quantum dot marking strip card of the present invention.
  • the quantum dot marking strip card of the preferred embodiment comprises a cartridge 3 and a quantum dot marking strip 2.
  • the quantum dot marking test strip 2 includes a sample pad 4, a marking pad 5, an analysis film 8, and an absorbent pad 9 which are sequentially attached to the substrate 1 by overlapping.
  • the analysis membrane 8 has a detection strip 6 and a quality control strip 7.
  • One end of the cartridge 3 and the upper opening of the cartridge end form a test strip slot 13 to facilitate the insertion of the quantum dot marking strip 2 into the cartridge 3.
  • the test strip 2 is a separate insertion structure of the cartridge 3.
  • the test strip 2 inserted into the cartridge 3 has one end of the sample pad 4 interfering with the open end of the cartridge 3 to be immersed to suck the sample.
  • the upper casing of the cartridge 3 is provided with a detection window 11 at a position corresponding to the test strip analysis film 8.
  • a storage medium 14 is mounted on the cartridge 3.
  • the marking pad 5 of the quantum dot marking strip 2 is coated with a single specific molecule associated with a single quantum dot-labeled target detection object; or: each target analyte coated with a different single quantum dot corresponding label A mixture of related specific molecules is detected.
  • the single quantum dot of the test strip 2 marking pad 5 may be selected from the group consisting of ZnS, CdS, HgS, ZnSe, CdSe, HgSe, CdTe, ZnTe, ZnO, PbSe, HgTe, CaAs, InP, InAs, InCaAs, CdS/ ZnS, CdS/Ag 2 S, CdS/PbS, CdS/Cd(0H) 2 , CdS/HgS, CdS/HgS/CdS, ZnS/CdS, ZnS/CdS/ZnS, ZnS/HgS/ZnS/CdS, CdSe/ CdS, CdSe/ZnS, CdSe/CuSe, CdSe/HgTe, CdSe/HgSe, CdSe/HgSe/CdSe, CdSe/CuSe
  • the detection strip 6 of the quantum dot marking strip 2 may be one (shown in FIGS. 1 and 2) or a plurality of strips (shown in FIGS. 3 and 4).
  • the test strip 6 is coated with another specific molecule related to the detection of a certain target analyte; or: a mixture of another specific molecule coated with detection of each target analyte.
  • the quality control strip 7 of the quantum dot marking strip 2 is coated with a quality control.
  • the control includes a secondary antibody.
  • the storage medium 14 includes, but is not limited to, an RFID tag, an IC chip, a magnetic code, or a barcode. It stores the standard curve or coefficient parameter of the sample for quantitative sample concentration of the same batch of quantum dot labeling test strip 2, the optical density reference reference value of the test strip quality control strip, the test strip batch number, the test strip validity period, the storage medium password. , clinical indicator reference value, test strip manufacturer information, etc., and can read the object identification information, tester information, sample name, sample number, date of detection, test results and other information.
  • the standard curve of the object stored in the storage medium 14 can be selected in various forms, including but not limited to the following curve: the correspondence between the concentration of the standard sample of the object to be tested and the OD detection zone /OD control zone Relationship curve; or, the corresponding relationship between the concentration of the sample standard series and the OD detection zone / (OD detection zone + OD quality control zone ).
  • the OD detection zone is the optical density value of the detection zone measured by the concentration of the standard sample of the test object
  • the OD quality control zone is the optical density value of the quality control zone measured by the concentration of the standard sample of the test object.
  • the marking pad 5 of the quantum dot marking strip 2 is a glass fiber membrane;
  • the analysis membrane 8 of the quantum dot marking strip 2 is a nitrocellulose membrane, a nylon membrane, or a nitrocellulose/cellulose acetate mixed membrane;
  • the underlayer 1 of the quantum dot marking strip 2 is a polyester or plastic plate;
  • the cartridge 3 is made of polyester, plastic, hard paper material, or other material.
  • the quantum dot marking test strip 2 is a disposable product, and the storage medium 14 on the cartridge 3 and the cartridge 3 is a used product matched with the same batch of quantum dot marking test strips 2.
  • the quantum dot marking test strip 2 When the quantum dot marking test strip card is used for sample detection, the quantum dot marking test strip 2 is currently inserted into the cartridge 3, and the liquid protruding sample is immersed in the interference protruding end of the test strip 2 inserted into the cartridge 3 to suck the liquid sample.
  • the characteristic signal of the test strip 2 detection strip 6 and the quality control strip 7 is collected by the instrument having the signal detecting function (such as a reading instrument, a fluorescence detector, etc.) and combined with the instrument.
  • the sample one-component or multi-component concentration is calculated from the test sample standard curve or coefficient parameter simultaneously read from the test strip storage medium 14.
  • the sample to be tested of the quantum dot-labeled test strip card may be from clinical or non-clinical blood, body fluid, urine, saliva, genital tract secretion or other liquid sample or viscous sample, wherein the clinical sample includes infectious diseases Samples such as hormones, cardiovascular diseases, tumors, cancer, diabetes, autoimmune diseases, etc.
  • infectious diseases Samples such as hormones, cardiovascular diseases, tumors, cancer, diabetes, autoimmune diseases, etc.
  • Non-clinical samples include food testing, environmental pollution testing, pesticide residue testing, biological contamination testing, biological agent testing, veterinary testing, Samples such as drug testing.
  • Embodiment 2 is another preferred embodiment of the quantum dot marking strip card of the present invention.
  • the quantum dot marking strip card of the preferred embodiment comprises a cartridge 3 and a quantum dot marking strip 2.
  • the quantum dot marking strip 2 includes a sample pad 4, a marker pad 5, an analysis film 8, an absorbent pad 9, and a strip reaction end indicating label 10 which are sequentially attached to the substrate 1.
  • the analysis membrane 8 has a detection strip 6 and a quality control strip 7.
  • One end of the cartridge 3 and the upper opening of the cartridge end form a test strip slot 13 to facilitate the insertion of the quantum dot marking strip 2 into the cartridge 3.
  • Test strip 2 is a disconnected structure of the cartridge 3. At the time of sample detection, the test strip 2 inserted into the cartridge 3 has one end of the sample pad 4 interfering with the open end of the cartridge 3 to be immersed to suck the sample.
  • the upper casing of the cartridge 3 is provided with a detection window 11 at a position corresponding to the test strip analysis film 8, and the upper casing of the cartridge 3 is provided with an observation window 12 at a position corresponding to the test strip end point indicating label 10, the cartridge A storage medium 14 is mounted on the third.
  • the marking pad 5 of the quantum dot marking strip 2 is coated with a single specific molecule associated with a single quantum dot-labeled target detection object; or: each target analyte coated with a different single quantum dot corresponding label A mixture of related specific molecules is detected.
  • the single quantum dot of the strip mark pad 5 may be selected from the group consisting of ZnS, CdS, HgS, ZnSe, CdSe, HgSe, CdTe, ZnTe, ZnO, PbSe, HgTe, CaAs, InP, InAs, InCaAs, CdS/ZnS.
  • the detection strip 6 of the quantum dot marking strip 2 may be one (shown in FIGS. 5 and 6) or a plurality of strips (shown in FIGS. 7 and 8).
  • the test strip 6 is coated with another specific molecule related to the detection of a certain target analyte; or: a mixture of another specific molecule coated with detection of each target analyte.
  • the quality control strip 7 of the quantum dot marking strip 2 is coated with a quality control.
  • the control includes a secondary antibody.
  • the strip reaction end point indicator 10 includes a pH test strip having a discoloration range of 5-9.
  • the test strip reaction end point on the test strip indicates that the label 10 can be colored according to the pH condition of the test strip reaction, to indicate whether the test strip reactant has sufficiently oozing through the test strip 6 and the quality control strip 7, prompting the test Whether the strip reaction is sufficient and whether the test result is valid.
  • the storage medium 14 includes, but is not limited to, an RFID tag, an IC chip, a magnetic code, or a barcode. It stores the standard curve or coefficient parameter of the sample for quantitative sample concentration of the same batch of quantum dot labeling test strip 2, the optical density reference reference value of the test strip quality control strip, the test strip batch number, the test strip validity period, the storage medium password. , clinical indicator reference value, test strip manufacturer information, etc., and can read the object identification information, tester information, sample name, sample number, date of detection, test results and other information.
  • the standard curve of the object stored in the storage medium 14 can be selected in various forms, including but not limited to the following curve: the correspondence between the concentration of the standard sample of the object to be tested and the OD detection zone /OD control zone Relationship curve; or, the corresponding relationship between the concentration of the sample standard series and the OD detection zone / (OD detection zone + OD quality control zone ).
  • the OD detection zone is the optical density value of the detection zone measured by the concentration of the standard sample of the test object
  • the OD quality control zone is the optical density value of the quality control zone measured by the concentration of the standard sample of the test object.
  • the marking pad 5 of the quantum dot marking strip 2 is a glass fiber membrane;
  • the analysis membrane 8 of the quantum dot marking strip 2 is a nitrocellulose membrane, a nylon membrane, or a nitrocellulose/cellulose acetate mixed membrane;
  • the underlayer 1 of the quantum dot marking strip 2 is a polyester or plastic plate;
  • the cartridge 3 is made of polyester, plastic, hard paper material, or other material.
  • the quantum dot marking strip 2 is a disposable product.
  • the storage medium 14 on the cartridge 3 and the cartridge 3 is used for the same batch of quantum dot marking strips 2.
  • the quantum dot marking test strip card When the quantum dot marking test strip card is used for sample detection, the quantum dot marking test strip 2 is currently inserted into the cartridge 3, and the liquid protruding sample is immersed in the interference protruding end of the test strip 2 inserted into the cartridge 3 to suck the liquid sample.
  • Test strip reaction end point indication label 10 color display indicator sample after the test strip 2 completes the test strip reaction, the instrument with signal detection function (such as reading instrument, fluorescence detector, etc.) collects test strip 2 detection strip 6 and quality control
  • the characteristic signal of the strip 7 is combined with the standard curve or coefficient parameter of the sample simultaneously read from the strip card storage medium 14 to obtain a single component or multi-component concentration of the sample.
  • the sample to be tested of the quantum dot-labeled test strip card may be from clinical or non-clinical blood, body fluid, urine, saliva, genital tract secretion or other liquid sample or viscous sample, wherein the clinical sample includes infectious diseases Samples such as hormones, cardiovascular diseases, tumors, cancer, diabetes, autoimmune diseases, etc.
  • infectious diseases Samples such as hormones, cardiovascular diseases, tumors, cancer, diabetes, autoimmune diseases, etc.
  • Non-clinical samples include food testing, environmental pollution testing, pesticide residue testing, biological contamination testing, biological agent testing, veterinary testing, Samples such as drug testing.
  • the quantum dot-labeled test strip card of the present invention may have other improvements, such as a storage medium 14 storing detection information such as a test sample standard curve, in addition to the cartridge 3 mounted on the test strip card. Above and outside, it can also be directly mounted on the quantum dot marking strip 2; based on the same principle of the invention, the quantum dot marking strip inserted into the cartridge 3 can also be extended to replace the quantum dot labeled biochip (including antigenic antibodies). Chips, protein chips, nucleic acid chips, microfluidic chips, etc. Therefore, any other technical solution formed by any equivalent replacement or equivalent transformation of the quantum dot-labeled test strip card of the present invention falls within the scope of protection of the present invention.

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Abstract

L'invention concerne une carte de bande d'essai marquée par des points quantiques comprenant un boîtier de carte (3) et une bande d'essai (2) marquée par des points quantiques. Une extrémité du boîtier de carte (3) est ouverte pour former une ouverture à rainure d'insertion de la bande d'essai (13). La bande d'essai (2) est une structure détachable-enfichable du boîtier de carte (3). Monté sur le boîtier de carte (3) se trouve un moyen de stockage (14) ayant des informations stockées comme une courbe standard d'échantillon de matériau testé. Quand on teste un échantillon, une extrémité d'un coussin absorbant l'échantillon (4) de la bande d'essai (2) inséré dans le boîtier de carte (3) est disposée de façon à dépasser de l'extrémité ouverte du boîtier de carte (3) afin de l'immerger dans l'échantillon de sorte qu'elle l'absorbe, et ensuite, des signaux caractéristiques d'une bande d'essai (6) et d'une bande témoin de qualité (7) de la bande d'essai (2) sont récoltés par un instrument ayant une fonction de détection de signal et sont combinés avec la courbe standard du matériau testé ou les paramètres de coefficient lus simultanément par l'instrument à partir du milieu de stockage (14) pour acquérir par calcul la concentration d'un seul composant ou de composants multiples de l'échantillon. La carte de bande d'essai fournit un test d'échantillon ayant les avantages de simplicité et de rapidité, de grande flexibilité, de résultat objectif, et d'utilisation flexible.
PCT/CN2014/089565 2013-11-12 2014-10-27 Carte de bande d'essai marquée par des points quantiques WO2015070700A1 (fr)

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CN109917142A (zh) * 2019-04-01 2019-06-21 北京怡成生物电子技术股份有限公司 一种血样多指标联测卡盒

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