WO2015070745A1

WO2015070745A1 - Test strip card marked by quantum dots

Info

Publication number: WO2015070745A1
Application number: PCT/CN2014/090848
Authority: WO
Inventors: 马义才; 顾敏; 马灵
Original assignee: 成都领御生物技术有限公司; 马义才
Priority date: 2013-11-14
Filing date: 2014-11-11
Publication date: 2015-05-21
Also published as: CN103675266A

Abstract

A test strip card marked by quantum dots, the test strip card comprising a card case (3) and a quantum dot marked test strip (2) located therein; the card case (3) has a storage medium (11) thereon stored with testing information such as a standard curve of a sample object to be tested; when conducting sample testing, the test strip card collects, via an instrument having a signal detection function, the characteristic signal of a detection band (6) of the test strip (2), and combines the standard curve or coefficient parameter of the object to be tested simultaneously read by the instrument from the storage medium (11) so as to calculate and obtain the single-component or multicomponent concentration of the sample. Utilizing the test strip card for sample detection is convenient and fast, and is flexible and highly sensitive, and produces objective results.

Description

A quantum dot-labeled test strip card

Technical field

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.

Background technique

Gold-Immunochromatography Assay (GICA) has been widely used in all aspects of immunoassay. It uses a microporous membrane as a carrier and uses capillary action of a microporous membrane to make it drop on one end of the membrane strip. The liquid sample slowly migrates to the other end of the microporous membrane. If there is a specific antigen or antibody in the liquid, they can bind to the immunogold and then bind to the corresponding antibody or antigen coated on the microporous membrane to display immunity. Gold color (red). The technique is simple and fast, and the results can be observed with the naked eye in a matter of minutes. The shortcomings are: (1) It is only possible to qualitatively test the sample, and it is difficult to quantify the sample. (2) It is difficult to simultaneously test multiple components of the sample, and the detection efficiency is low. (3) For samples with very low antigen or antibody content, the colloidal gold color is very light and difficult to judge with the naked eye, and the detection sensitivity is low.

It has been a long-term goal for the rapid quantitative detection of multi-component samples. In recent years, nanometer quantum dots (QDs) have unique and excellent optical properties: high fluorescence efficiency, wide excitation line range, single-element excitation, multiple emission, narrow emission spectrum and symmetry, slow photobleaching, and fluorescence It has a long life span, similar particle size to biomolecules, and can be multi-functionalized after surface modification. The characteristic wavelength fluorescence spectra produced by a mixture of quantum dots of different particle sizes and types do not overlap, which is very suitable for multi-component analysis of samples. Sweeny et al. used three primary antibodies with quantum dots of three different emission wavelengths (

605nm and 655nm) form an antibody-quantum dot complex by specific binding of biotin-avidin, and simultaneous analysis of three different antibodies in the tonsil by fluorescence imaging, which proves that the application of multicolor quantum dots can be simultaneously in the same sample. Position multiple biomarkers. Nie et al. used four kinds of different wavelengths of quantum dots to label four kinds of antibodies to achieve imaging detection of Hodgkin's and Reed-Sternberg in Hodgkin's lymphoma, which improved detection sensitivity and specificity. Rapid and accurate diagnosis of Hodgkin's lymphoma. Kobayashi et al. and Chan et al. used two different color near-infrared quantum dot images to analyze the lymphatic flow and left and right thoracic cavity of mice, respectively, demonstrating the multiple imaging analysis of near-infrared quantum dots. In addition to image analysis, qualitative and quantitative analysis of various pathogens, toxins, antigens, antibodies, enzymes, small molecules, and ions can be performed by using the fluorescence characteristics of quantum dots. Zahavy et al. Preparation of fluorescent probes

Anthracis and

Pestis, combined with flow cytometry, enables simultaneous quantitative detection of two pathogenic bacteria with a detection limit of 10 ³ cfu/mL. 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. In addition, 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. Giorgio et al. constituting a fluorescent probe with vascular endothelial growth factor A (VEGF A) and angiopoietin (angiopoietin) and quantum dots of different emission wavelengths respectively, and causing aggregation of quantum dots by antigen-antibody specific binding reaction, using flow cytometry The characteristic fluorescent signal was quantitatively 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. In recent years, many researchers have used 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. . In theory, n kinds of intensity m colors can generate n ^m -1 kinds of codes, and the detection and detection of n ^m -1 targets can be realized by decoding technology. According to 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. encapsulated three different color quantum dots of red, green and blue into a polystyrene microsphere at a ratio of 1:1:1, 1:2:1, and 2:1:1 to encode the obtained fluorescence spectrum. Different characteristics enable simultaneous detection of three target DNAs. Using similar techniques, Gu and Sha et al. quantified single-stranded DNA with multiple different sequences by encoding two different wavelengths of quantum dots with three intensities to encode DNA-sensitive hydrogels and microspheres, respectively. High throughput screening typing of multiple oligonucleotides. 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 application number patent 200410010736.3, using colloidal gold labeled antibody to bind to the target, and binding to the quantum dot-labeled antibody on the membrane by immunoreaction to form a detection zone, which is based on the preliminary qualitative or semi-quantitative detection of the detection zone by the naked eye. On the top, the fluorescence quenching effect of the colloidal gold on the fluorescent nanoparticles is utilized, and the detection band is quantitatively detected by detecting the quenching degree of the fluorescent signal. The patent uses two kinds of particle labeling, and the method is not simple enough; the quantification degree of the fluorescent signal is used for quantitative detection, the interference factor is large, and the detection sensitivity is low.

Chinese Patent Application No. 200610024086.7 discloses a method for detecting a quantum dot-labeled rapid immunochromatographic test strip. Although 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. Moreover, 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. If 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. (2) Using a UV lamp to illuminate the test strip to observe the presence or absence of the fluorescent line or to determine whether the sample contains the target. In the true sense, this is still a qualitative test, or at most it can only reach a certain The minimum detectable limit of the test object cannot fundamentally achieve accurate concentration detection of any component in the sample, and the sensitivity is still low.

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 strip card on which a storage medium 11 is mounted. The storage medium 11 stores the same batch of quantum dot marking strips 2 for quantitative detection. Information for testing such as standard curve or coefficient parameters for concentration. After the sample is reacted on the test strip 2, the characteristic signal of the test strip 2 in the test strip 2 is collected by the instrument having the signal detecting function, and the detected object is simultaneously read from the storage medium 11 by the instrument. The standard curve or coefficient parameters are calculated to obtain the one-component or multi-component concentration of the sample. 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.

Summary of the invention

The technical scheme of the present invention is as follows:

The quantum dot-labeled test strip card of the present invention comprises a cartridge 3 and a quantum dot marking strip 2 therein. Quantum dot The test strip 2 includes a sample pad 4, a marker pad 5, an analysis film 7, and an absorbent pad 8 which are sequentially attached to the substrate 1 by laps. The analysis membrane 7 has a detection strip 6. The upper surface of the cartridge 3 is provided with a sample insertion hole 9 at a position corresponding to the test strip sample pad 4. The upper surface of the cartridge 3 is opened with a detection window 10 at a position corresponding to the test strip analysis film 7. A storage medium 11 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, CdTe/HgTe, InAs/InP, InAs/CdSe, InAs/ZnSe, MgS, MgSe, MgTe, CaS, Any one or any of several kinds of nanoparticles of CaSe, CaTe, SrS, SrSe, SeTe, BaS, BaSe, BaTe, CdS: Mn, ZnS: Mn, CdS: Cu, ZnS: Cu, CdS: Tb, ZnS: Tb The combination, and the core-shell type nanocomposite particles in which any one of the above quantum dots is a core and silica is a shell.

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 storage medium 11 includes, but is not limited to, an RFID tag, an IC chip, a magnetic code, or a barcode. The storage medium 11 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 test strip batch number, the strip validity period, the storage medium password, the clinical index reference value, and the test strip. Manufacturer information, etc., and can read information such as the identity information of the object to be tested, the information of the detector, the name of the sample, the sample number, the date of detection, and the test result.

The standard curve of the sample stored in the storage medium 11 can be selected in various forms including, but not limited to, a corresponding relationship between the concentration of the sample standard series and the OD _{detection zone} . The OD _{detection zone is} defined as the detection band optical density value measured by the concentration of the sample standard series.

After the water absorbing pad 8 of the quantum dot marking test strip 2 of the present invention, a test strip reaction end point indicating label 12 can be overlapped. Correspondingly, the test strip reaction end point of the cartridge 3 indicates that the label 12 has a viewing window 13 corresponding thereto. The strip reaction end point indicator 12 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 7 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.

When the sample is detected, the test strip with the sample applied is subjected to the chromatographic reaction of the test strip, and the characteristic signal of the strip 2 of the strip 2 is collected by the instrument with the signal detecting function, and simultaneously read from the storage medium 11 in combination with the instrument. The single component or multi-component concentration of the sample is calculated by taking the corresponding test sample standard curve or coefficient parameter.

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.

Compared with the prior art, the present invention has the following beneficial effects:

(1) The test strip card can be combined with a signal detecting function (such as a reading instrument, a fluorescence detector, etc.) to realize multiple sets of samples. Sub-synchronous 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.

(2) 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 11. When the sample is tested, 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 the instrument collects the characteristic fluorescent signal of the strip 2 of the test strip 2, and combines the The standard test curve or coefficient parameter of the corresponding test object read from the storage medium 11 can quantitatively obtain the sample test result in a few minutes.

(3) The amount of sample is small, and a few microliters to several tens of microliters can meet the detection needs.

(4) 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.

DRAWINGS

Figure 1 is a top plan view of a preferred embodiment of the quantum dot marking strip card of the present invention (showing a test line in the inner test strip)

2 is a side view structural view of a test strip in a cartridge of the first preferred embodiment of the quantum dot marking strip card of the present invention (the test strip adopts a detection line)

Figure 3 is a top plan view of a preferred embodiment of the quantum dot-labeled test strip card of the present invention (showing that multiple test lines are used in the test strip)

4 is a side view structural view of a test strip in a cartridge of the first preferred embodiment of the quantum dot marking strip card of the present invention (the test strip adopts a plurality of detecting lines)

Figure 5 is a top plan view of another preferred embodiment of the quantum dot marking strip card of the present invention (showing a test line in the inner test strip)

6 is a side view structural view of a test strip in a cartridge according to another preferred embodiment of the quantum dot marking strip card of the present invention (the test strip adopts a detection line)

Figure 7 is a top plan view of another preferred embodiment of the quantum dot-labeled test strip card of the present invention (showing a plurality of test lines in the inner test strip)

8 is a side view structural view of a test strip in a cartridge according to another preferred embodiment of the quantum dot marking strip card of the present invention (the test strip adopts a plurality of detecting lines)

The serial number is as follows:

1, underlay, 2, test strip, 3, cartridge, 4, sample pad, 5, marker pad, 6, test tape, 7, analysis membrane, 8, absorbent pad, 9, sample hole, 10, detection window 11, storage medium, 12, test strip reaction end indication label, 13, observation window.

detailed description

The following examples and the accompanying drawings are only intended to further illustrate the invention, and those skilled in the art should not limit the scope of the invention.

Embodiment 1

Figures 1-4 illustrate a first embodiment. Embodiment 1 is one of the preferred embodiments of the quantum dot marking strip card of the present invention.

In Figures 1-4, 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 marking pad 5, an analysis film 7, and an absorbent pad 8 which are sequentially attached to the substrate 1. The analysis membrane 7 has a detection strip 6. The upper surface of the cartridge 3 is provided with a sample insertion hole 9 at a position corresponding to the test strip sample pad 4. The upper surface of the cartridge 3 is opened with a detection window 10 at a position corresponding to the test strip analysis film 7. A storage medium 11 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 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/ZnSe, CdSe/CuSe, CdSe/HgTe, CdSe/HgSe, CdSe/HgSe/CdSe, CdTe/HgS, CdTe/HgTe, InAs/InP, InAs/CdSe, InAs/ZnSe, MgS, Any one of MgSe, MgTe, CaS, CaSe, CaTe, SrS, SrSe, SeTe, BaS, BaSe, BaTe, CdS: Mn, ZnS: Mn, CdS: Cu, ZnS: Cu, CdS: Tb, ZnS: Tb Or a combination of any of several kinds of nanoparticles, and a core-shell type nanocomposite particle in which any one of the above quantum dots is a core and silica is a shell.

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 associated with detection of a target analyte, or a mixture of another specific molecule coated with detection of each target analyte.

The storage medium 11 includes, but is not limited to, an RFID tag, an IC chip, a magnetic code, or a barcode. The standard curve or coefficient parameter of the test object, the test strip batch number, the test strip validity period, the storage medium password, the clinical index reference value, and the test strip manufacturer information are stored in the same batch of quantum dot labeling strip 2 quantitative sample concentration. Etc., and can read information such as the identity information of the object to be tested, the information of the detector, the name of the sample, the sample number, the date of detection, and the test result.

The marking pad 5 of the quantum dot marking strip 2 is a glass fiber membrane; the analysis membrane 7 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.

When the sample is detected, the quantum dot marking test strip card collects the characteristic signal of the strip 2 of the test strip 2 by the instrument with the signal detecting function, and combines the standard curve of the detected object simultaneously read from the storage medium 11 by the instrument. Or the coefficient parameter is calculated to obtain the 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. 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

Figures 5-8 illustrate a second embodiment. Embodiment 2 is another preferred embodiment of the quantum dot marking strip card of the present invention.

In Figures 5-8, 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 7, an absorbent pad 8, and a test strip reaction end indicating label 12 which are sequentially attached to the substrate 1. The analysis membrane 7 has a detection strip 6. The upper surface of the cartridge 3 is provided with a sample insertion hole 9 at a position corresponding to the sample strip 4 of the test strip, and the upper surface of the cartridge 3 is opened with a detection window 10 at a position corresponding to the test strip analysis film 7, the cartridge The upper casing of the 3 is provided with an observation window 13 at a position corresponding to the end point of the test strip indicating the label 12, and the storage medium 11 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 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. , 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, CdTe/HgTe, InAs/InP, InAs/CdSe, InAs/ZnSe, MgS, MgSe Any one of MgTe, CaS, CaSe, CaTe, SrS, SrSe, SeTe, BaS, BaSe, BaTe, CdS: Mn, ZnS: Mn, CdS: Cu, ZnS: Cu, CdS: Tb, ZnS: Tb or A combination of any of several kinds of nanoparticles, and a core-shell type nanocomposite particle in which any one of the above quantum dots is a core and silica is a shell.

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 associated with detection of a target analyte, or a mixture of another specific molecule coated with detection of each target analyte.

The strip reaction end point indicator 12 includes, but is not limited to, a pH test strip having a color shift range of 5-9. When the sample is tested, the test strip reaction end point on the test strip indicates that the label 12 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, indicating whether the strip reaction is sufficient, Whether the test result is valid.

When the quantum dot marking test strip card is used for sample detection, the liquid sample is applied to the sample loading hole 9 of the test strip card, and the test strip reaction end point of the inner test strip 2 is indicated by the label 12 color display indicator strip 2 is completed. After the reaction, the characteristic signal of the strip 6 is collected by the instrument with the signal detecting function, and combined with the standard curve or coefficient parameter of the object simultaneously read from the storage medium 11 to calculate the single component of the sample. Or multi-component concentration.

It should be noted that the quantum dot-labeled test strip card of the present invention may have other improvements, such as a storage medium 11 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 in the cartridge 3 can also be extended to replace the quantum dot labeled biochip (including antigen antibody chip, 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.

Claims

A quantum dot-labeled test strip card comprising a cartridge (3) and a quantum dot marking strip (2) therein, the quantum dot marking strip (2) comprising a sequential overlap and fixing on the substrate (1) Sample pad (4), marking pad (5), analysis film (7), absorbent pad (8), analysis film (7) has detection tape (6), detection tape (6) is one or more, and the cartridge The upper surface of (3) has a sample hole (9) at a position corresponding to the sample strip (4) of the test strip, and the upper surface of the cassette (3) is opened at a position corresponding to the test strip (7) of the test strip. There is a detection window (10), which is characterized by:

The storage box (3) is mounted with a storage medium (11);

The marking pad (5) of the quantum dot marking strip (2) is coated with a single quantum dot-labeled target specific analyte for detecting a single specific molecule, or: each coated with a different single quantum dot corresponding label Target analytes detect a mixture of related specific molecules;

The detection band (6) of the quantum dot labeling strip (2) is coated with another specific molecule associated with detection of a target analyte, or: another specific molecule coated with detection of each target analyte mixture.
The quantum dot-labeled test strip card according to claim 1, wherein said single quantum dot of said marking pad (5) of said quantum dot marking strip (2) comprises ZnS, CdS, HgS, ZnSe , CdSe, HgSe, CdTe, ZnTe, ZnO, PbSe, HgTe, CaAs, InP, InAs, InCaAs, CdS/ZnS, CdS/Ag2S, 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, CdTe/HgTe, InAs/InP, InAs/CdSe, InAs/ZnSe, MgS, MgSe, MgTe, CaS, CaSe, CaTe, SrS, SrSe, SeTe, BaS, BaSe, BaTe, CdS: Mn, ZnS : Mn, CdS: Cu, ZnS: Cu, CdS: Tb, ZnS: Tb, or a combination of any of several kinds of nanoparticles, and a core in which any one of the above quantum dots is a core and silica is a shell - Shell-type nanocomposite particles.
A quantum dot-labeled test strip card according to claim 1, wherein said storage medium (11) comprises an RFID tag, an IC chip, a magnetic code, or a barcode.
The quantum dot-labeled test strip card according to claim 1, wherein the storage medium (11) stores the same batch of quantum dot-labeled test strips (2) the standard curve of the sample for quantitative sample concentration Or coefficient parameter, test strip batch number, test strip validity period, storage medium password, clinical index reference value, test strip manufacturer information, and can read the object identification information, detector information, sample name, sample number, and test date , test result information.
The quantum dot-labeled test strip card according to claim 4, wherein the standard curve of the test object stored in the storage medium (11) has various forms to be selected, and includes a standard sample series of the test object. A correspondence curve between the concentration and the OD detection zone ; the OD detection zone is defined as a detection band optical density value measured by the concentration of the sample standard series.
The quantum dot-labeled test strip card according to claim 1, wherein:

The marking pad (5) of the quantum dot marking strip (2) is a glass fiber membrane, and the analysis membrane (7) of the quantum dot marking strip (2) is a nitrocellulose membrane, a nylon membrane, or a nitrocellulose / cellulose acetate mixed film;

The underlayer (1) of the quantum dot marking strip (2) is a polyester or plastic plate;

The cartridge (3) is made of polyester, plastic, or a hard paper material.
The quantum dot-labeled test strip card according to claim 1, characterized by: an instrument having a signal detecting function Collecting the test strips (2) detecting the characteristic signals of the strips (6) and calculating the single-component or multi-component concentration of the sample by combining the standard curve or coefficient parameters of the test object simultaneously read by the instrument from the storage medium (11) .
A quantum dot-labeled test strip card according to claim 1, wherein the water-absorbing pad (8) of the quantum dot-labeled test strip (2) is further overlapped with a test strip reaction end point indicating label ( 12); the test strip reaction end label (12) of the cartridge (3) has an observation window (13) corresponding thereto.
The quantum dot-labeled test strip card according to claim 8, wherein the strip reaction end point indicating label (12) comprises a pH test strip having a discoloration range of 5-9.
The quantum dot-labeled test strip card according to claim 8, wherein said single quantum dot of said marking pad (5) of said quantum dot marking strip (2) comprises ZnS, CdS, HgS, ZnSe , CdSe, HgSe, CdTe, ZnTe, ZnO, PbSe, HgTe, CaAs, InP, InAs, InCaAs, CdS/ZnS, CdS/Ag2S, 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, CdTe/HgTe, InAs/InP, InAs/CdSe, InAs/ZnSe, MgS, MgSe, MgTe, CaS, CaSe, CaTe, SrS, SrSe, SeTe, BaS, BaSe, BaTe, CdS: Mn, ZnS : Mn, CdS: Cu, ZnS: Cu, CdS: Tb, ZnS: Tb, or a combination of any of several kinds of nanoparticles, and a core in which any one of the above quantum dots is a core and silica is a shell - Shell-type nanocomposite particles.
A quantum dot-labeled test strip card according to claim 8, wherein said storage medium (11) comprises an RFID tag, an IC chip, a magnetic code, or a barcode.
The quantum dot-labeled test strip card according to claim 8, wherein the storage medium (11) stores the same batch of quantum dot-labeled test strips (2) the standard curve of the sample for quantitative sample concentration Or coefficient parameter, test strip batch number, test strip validity period, storage medium password, clinical index reference value, test strip manufacturer information, and can read the object identification information, detector information, sample name, sample number, detection Date, test result information.
The quantum dot-labeled test strip card according to claim 12, characterized in that: the standard curve of the test object stored in the storage medium (11) has various forms to be selected, and includes a standard sample series of the test object. A correspondence curve between the concentration and the OD detection zone ; the OD detection zone is defined as a detection band optical density value measured by the concentration of the sample standard series.
The quantum dot-labeled test strip card according to claim 8, wherein:

The marking pad (5) of the quantum dot marking strip (2) is a glass fiber membrane, and the analysis membrane (7) of the quantum dot marking strip (2) is a nitrocellulose membrane, a nylon membrane, or a nitrocellulose / cellulose acetate mixed film;

The underlayer (1) of the quantum dot marking strip (2) is a polyester or plastic plate;

The cartridge (3) is made of polyester, plastic, or a hard paper material.
The quantum dot-labeled test strip card according to claim 8, wherein the instrument having the signal detecting function collects the test strip (2) the characteristic signal of the detecting strip (6) and combines the instrument from the storage medium (11). The single-component or multi-component concentration of the sample is calculated by simultaneously reading the test sample standard curve or the coefficient parameter.
A quantum dot-labeled test strip according to claim 1 or 8, wherein the sample to be tested is from clinical or non-clinical blood, body fluid, urine, saliva, genital secretions or other liquid samples. Or a viscous sample, Clinical samples include infectious diseases, hormones, cardiovascular diseases, tumors, cancer, diabetes, autoimmune diseases, and non-clinical samples including food testing, environmental pollution testing, pesticide residue testing, biological contamination testing, and biological agents. Samples for testing, veterinary testing, and drug testing.