WO2015070700A1

WO2015070700A1 - Quantum dot-labeled test strip card

Info

Publication number: WO2015070700A1
Application number: PCT/CN2014/089565
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: 2013-11-12
Filing date: 2014-10-27
Publication date: 2015-05-21
Also published as: CN103630682A

Abstract

A quantum dot-labeled test strip card comprising a card case (3) and a quantum dot-labeled test strip (2). One extremity of the card case (3) is opened to form a test strip insertion groove opening (13). The test strip (2) is a detachable-pluggable structure of the card case (3). Mounted onto the card case (3) is a storage medium (14) having stored information such as a sample tested-material standard curve. When testing a sample, one extremity of a sample absorbing pad (4) of the test strip (2) inserted into the card case (3) is interference extended out of the opened extremity of the card case (3) to be immersed in the sample to absorb same, and then, characteristic signals of a testing strip (6) and of a quality control strip (7) of the test strip (2) are collected by an instrument having a signal detection function and are combined with the tested-material standard curve or coefficient parameters read simultaneously by the instrument from the storage medium (14) to acquire by calculation the concentration of a single component or multiple components of the sample. The test strip card provides sample testing with the advantages of simplicity and rapidness, great flexibility, objective result, and flexible use.

Description

一种量子点标记的试条卡A quantum dot-labeled test strip card

技术领域Technical field

本发明属于体外诊断领域，具体涉及一种自身带有被检物标准曲线或系数参数等检测用信息、结合具有信号检测功能的仪器能快速定量样品单一组分或多组分浓度的量子点标记的试条卡。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.

背景技术Background technique

胶体金免疫层析技术(Gold-Immunochromatography Assay，GICA)现已广泛应用于免疫检测的各个方面，其以微孔滤膜为载体，利用微孔滤膜的毛细管作用，使滴加在膜条一端的液体样品慢慢向微孔滤膜另一端渗移，若液体中有特异抗原或抗体，它们可以和免疫金结合后再与包被在微孔滤膜上的相应抗体或抗原结合而显示免疫金颜色(红色)。该技术简单快速，几分钟就能用肉眼观察结果。不足之处是：(1)只能定性检测样品，难能实现样品定量。(2)难能做到样品多组分同时检测，检测效率低。(3)对于某些抗原或抗体含量极低的样本，胶体金颜色很浅很难用肉眼判断结果，检测灵敏度低。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.

实现样品多组分快速定量检测，一直是人们长期追求的目标。近年发展的纳米量子点(quantum dots,QDs)，具有独特优良光学性质：荧光发光效率高，激发谱线范围宽，能一元激发，多元发射，发射谱线范围窄且对称，光漂白速度慢，荧光寿命长，粒径与生物分子相近，表面修饰后能多功能化，不同粒径和种类的量子点混合物产生的特征波长荧光光谱不交叠，非常适于样品多组分分析。Sweeny等将三种一抗分别与三种不同发射波长的量子点(

605nm和655nm)通过生物素-亲和素的特异性结合形成抗体-量子点复合物，通过荧光成像实现了扁桃体中3种不同抗体的同时分析，证明应用多色量子点可在同一样品中同时定位多种生物标志物。Nie等用4种不同发射波长的量子点标记4种抗体实现了对霍奇金淋巴瘤中病理标志性细胞HRS(Hodgkin’s and Reed-Sternberg)的成像检测，提高了检测灵敏度和特异性，有利于临床快速准确地诊断霍奇金淋巴瘤。Kobayashi等和Chan等分别用两种不同颜色的近红外量子点成像分析小鼠的***流路和左右胸腔，证明了近红外量子点的多重成像分析作用。利用量子点的荧光特性除了进行成像分析外还可以实现对多种病原体、毒素、抗原、抗体、酶、小分子物质以及离子等的定性定量分析。Zahavy等制备荧光探针

anthracis和

pestis，结合流式细胞仪实现了两种致病菌的同时定量检测，检测限可达到10³cfu/mL。Goldman课题组用多色量子点实现了葡萄球菌产生的肠毒素B和2,4,6-***以及霍乱毒素、蓖麻毒素、志贺毒素和葡萄球菌毒素四种毒素的同时检测。除此之外，在微流体蛋白质芯片中用量子点作荧光标记，利用其荧光多色性能够同时快速检测肿瘤标志物癌胚抗原(CEA)和甲胎蛋白(AFP)，检测限低至250fmol/L，比用有机荧光染料检测高4个数量级。Giorgio等将血管内皮生长因子A(VEGFA)和血管生成素(angiopoietin)分别与不同发射波长的量子点构成荧光探针，通过抗原抗体特异性结合反应引起量子点的聚集，用流式细胞仪定量检测特征荧光信号从而得到相应抗原的浓度，检测限为1pmol/L，实现了多种抗原的同时检测。近些年来，不少研究者利用量子点编码的方法进行多组分分析。这一技术主要是借助量子点荧光颜色和荧光强度的丰富性进行编码，能够同时测定更多的组分，可实现对蛋白质分析、DNA分析及药物筛选等研究中所蕴藏的海量信息的同步分析。理论上，n种强度m种颜色能够产生n^m-1种代码，利用解码技术可以实现对n^m-1种目标物的分析检测。根据计算，只需用5～6种颜色与6种不同发光强度的量子点纳米粒子进行组合，就能得到10000～40000个可识别的纳米粒子编码微球。如果与10种不同发光强度的量子点纳米粒子进行组合，则能得到100万个可识别的纳米粒子编码微球，这些微球理论上可以对100万个不同的DNA或蛋白质进行编码标记，从而实现对样品中的100万个不同的DNA或蛋白质进行同时检测！Nie等将红、绿、蓝三种不同颜色的量子点以1:1:1、1:2:1、2:1:1的比例包裹入聚苯乙烯微球进行编码，通过所得荧光光谱的不同特性实现了三种目标DNA的同时检测。采用类似技术，Gu和Sha等将两种不同发射波长的量子点以三种强度分别对DNA敏感型的水凝胶和微球进行编码分别实现了多种不同序列的单链DNA的定量检测和多种寡核苷酸的高通量筛选分型。Wilson和Cooper等分别利用此技术实现了三种血清蛋白(鸡卵白蛋白OVA、牛血清白蛋白BSA、人血清白蛋白HAS)以及四种免疫球蛋白G(人IgG、兔IgG、鼠IgG、羊IgG)的同时检测。It has been a long-term goal for the rapid quantitative detection of multi-component samples. In recent years, nano 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, 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. 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. composed vascular endothelial growth factor A (VEGFA) and angiopoietin (angiopoietin) with 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. 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 kinds of 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).

中国申请号专利200410010736.3，用胶体金标记抗体与目标物结合，通过免疫反应与膜上包被量子点标记的抗体结合，形成检测带，在用肉眼对检测带进行初步定性或半定量检测的基础上，再利用胶体金对荧光纳米粒子的荧光淬灭作用，通过检测荧光信号的淬灭程度对检测条带进行定量检测。该专利要用两种粒子标记，方法不够简单；采用荧光信号的淬灭程度进行定量检测，干扰因素多，检测灵敏度低。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.

中国申请号专利200610024086.7披露了一种量子点标记快速免疫层析试纸条的检测方法。该专利虽能实现多组分同时检测，但请求保护的是一种方法，没有提出请求保护基于量子点标记快速免疫层析试纸条产品。而且，该方法存在不足：(1)实现样品多组分检测需要在分析膜上同时设置多条相应的检测线，即每条检测线只用于检测样品中的一种指标，检测效率低。如果检测者想要同步检测样品中大量组分、通量组分、甚至海量组分，一个小小试条不可能通过设置如此众多相应的检测线来实现检测目标。(2)采用紫外灯照射试纸条检测带与质控带以观察其荧光线有无或者强弱从而判断样品中是否含有目标物，真正意义上说，此仍是一种定性检测，或者至多只能达到对某种被检物的最低可检限测定，不能从根本上实现样品中任意组分的准确浓度检测，灵敏度仍低。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 strip and the control 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 Only the minimum detectable limit of a certain object can be determined, and the accurate concentration detection of any component in the sample cannot be fundamentally realized, and the sensitivity is still low.

采用被检物标准品标准曲线定量被检物浓度，是检测领域定量样品浓度的主要方法。信息领域近来发展的存贮介质，如RFID标签(又称射频识别标签)、IC芯片、磁码、条码等，用于信息存取识别现已广泛用于计算机、通讯、电子、商业、交通运输控制管理等领域，其中，尤其是RFID标签，体积小，存储信息容量大，识别无须人工干预，更是信息存取识别的理想手段，但目前很少有人将其用于生物医学检测。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.

本发明针对现有技术的不足和缺陷，提供一种其上安装有存贮介质14的量子点标记试条卡，该存贮介质14储存有同批次量子点标记试条2定量被检物浓度用的标准曲线或系数参数等检测用信息。样品在试条2上完成试条反应后，由具有信号检测功能的仪器采集试条卡卡盒3内试条2检测带6和质控带7的特征信号并结合该仪器从存贮介质14同时读取来的被检物标准曲线或系数参数而计算获得样品单组分或多组分浓度。本发明用于定量样品浓度特别是样品多组分浓度具有简便快速、灵敏度高、结果客观、使用灵活等特点。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. After the sample is subjected to the test strip reaction on the test strip 2, 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.

发明内容Summary of the invention

本发明技术方案如下： The technical scheme of the present invention is as follows:

本发明所述的量子点标记的试条卡，包括卡盒3和量子点标记试条2。所述量子点标记试条2包括顺次搭接固定在底衬1上的吸样垫4、标记垫5、分析膜8、吸水垫9。分析膜8具有检测带6和质控带7。卡盒3的一端连同该卡盒端的上盒面开口形成试条插槽口13，以方便量子点标记试条2能现时***卡盒3内。试条2为卡盒3的离式即插结构。样品检测时，插放到卡盒3内的试条2其吸样垫4一端过盈伸出卡盒3的开口端以浸渍吸取样品。卡盒3的上盒面在对应于试条分析膜8位置处开有检测窗11。卡盒3上安装有一存贮介质14。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.

所述量子点标记试条2的标记垫5包被有单一量子点标记的某一目标被检物检测相关的单一特异分子，或：包被有不同单一量子点对应标记的各目标被检物检测相关的特异分子的混合物。标记垫5包被的所述单一量子点包括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中的任意一种或任意几种纳米粒子的组合，以及由上述任意一种量子点为核、二氧化硅为壳的核-壳型纳米复合粒子。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.

所述量子点标记试条2的检测带6可以为一条，也可以为多条。检测带6包被有某一目标被检物检测相关的另一特异分子，或包被有各目标被检物检测相关的另一特异分子的混合物。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.

所述量子点标记试条2的质控带7包被有质控物。所述质控物包括二抗。The quality control strip 7 of the quantum dot marking strip 2 is coated with a quality control. The control includes a secondary antibody.

所述存贮介质14包括但不限于RFID标签、IC芯片、磁码、或条码等。存贮介质14储存有同批次量子点标记试条2定量样品浓度用的被检物标准曲线或系数参数、试条质控带光密度参考监控值、试条批号、试条效期、存贮介质密码、临床指标参考值、试条生产厂商信息等，且可读入被测对象身份信息、检测者信息、样品名称、样品编号、检测日期、检测结果等信息。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.

所述存贮介质14储存的被检物标准曲线有多种形式可供选择，其包括但不限于下述曲线：被检物标准品系列浓度与OD_检测带/OD_质控带之间的对应关系曲线；或，被检物标准品系列浓度与OD_检测带/(OD_检测带+OD_质控带)之间的对应关系曲线。其中，OD_检测带为被检物标准品系列浓度测得的检测带光密度值，OD_质控带为被检物标准品系列浓度测得的质控带光密度值。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} ). Wherein, 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, and 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.

本发明所述量子点标记试条2的吸水垫9之后还可以搭接有一试条反应终点指示标签10。相应地，其卡盒3的该试条反应终点指示标签10对应处开有观察窗12。所述试条反应终点指示标签10包括变色范围为5-9的pH试纸。After the water absorbing pad 9 of the quantum dot marking test strip 2 of the present invention, a test strip reaction end point indicating label 10 can be overlapped. Correspondingly, 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.

本发明所述量子点标记试条2的标记垫5为玻璃纤维膜；所述量子点标记试条2的分析膜8为硝酸纤维素膜、尼龙膜、或硝酸纤维素/醋酸纤维素混合膜；所述量子点标记试条2的底衬1为聚脂或塑料板；所述卡盒3为聚脂、塑料、硬性纸质材料、或其他材料做成。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.

本发明所述量子点标记试条2为一次性使用品，所述卡盒3及卡盒3上的存贮介质14为同批次量子点标记试条2配套的使用品。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.

本发明所述量子点标记试条卡用于样品检测时，其量子点标记试条2现时***卡盒3内，插放到卡盒3内的试条2的过盈伸出端浸渍吸取液体样品。液体样品在试条2上完成试条反应后，由具有信号检测功能的仪器(如读条仪、荧光检测仪等)采集试条2检测带6和质控带7的特征信号并结合该仪器从试条卡存贮介质14同时读取来的被检物标准曲线或系数参数而计算获得样品单组分或多组分浓度。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 After the strip reaction, 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.

本发明所述量子点标记试条卡的待检样品可以是来自临床或非临床的血液、体液、尿液、唾液、生殖道分泌物或其他液态样品或粘稠状样品，其中，临床样品包括传染病、激素、心血管病、肿瘤、癌症、糖尿病、自身免疫病等在内的样品，非临床样品包括食品检测、环境污染检测、农药残留量检测、生物沾染检测、生物制剂检测、兽医学检测、毒品检测等在内的样品。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.

与现有技术相比，本发明具有如下有益效果：Compared with the prior art, the present invention has the following beneficial effects:

(1)所述试条卡结合具有信号检测功能的仪器(如读条仪、荧光检测仪等)能实现样品多组分同步快速定量检测(包括定性检测)。不同粒径、种类和结构的量子点能产生不同特征波长持续荧光，量子点混合物产生的特征波长荧光峰谱不交叠，本发明采用不同量子点分别标记被检物相应反应分子，将其混合物包被在所述试条卡的试条2上与待测样品进行反应，通过测定试条2特征荧光信号，因而能快速定量样品多组分浓度。(1) The test strip card combined with the instrument with signal detection function (such as reading instrument, fluorescence detector, etc.) 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.

(2)检测样品时间短，几分钟就能获得结果。本发明定量样品浓度毋需操作者再制作被检物标准曲线，被检物的标准曲线或系数参数等检测用信息已备储存贮介质14上。样品检测时，操作者只需将施加有样品的试条卡待其完成试条反应后置入具有信号检测功能的仪器，由该仪器采集其试条2检测带6和质控带7的特征荧光信号，结合该仪器从存贮介质14同时读取来的相应被检物标准曲线或系数参数，几分钟就能定量获得样品检测结果。(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 14. 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 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.

(3)能对试条层析反应过程进行动态监测。本发明根据试条检测带和质控带的光密度比值(OD_检测带/OD_质控带或OD_检测带/(OD_检测带+OD_质控带))或系数参数、并结合存贮介质14存储的被检物标准曲线由具有信号检测功能的仪器(如读条仪、荧光检测仪等)分析确定被检物浓度。存贮介质14上还存储有标准曲线制作时被检物标准品的质控带光密度参考监控值(OD_质控带)。如果试条检测反应失败，检测过程得到的质控带光密度值(OD_质控带)会与存贮介质14存储的质控带光密度参考监控值(OD_质控带)存在极大统计学误差，提示试条反应失败。存贮介质14上的标准曲线和OD_质控带与试条卡内试条2相配套，以克服试条卡内置试条2因批次质量差异可能造成的被检物浓度检测差异。本发明所述试条2的尾端还可设有试条反应终点指示标签10，该标签用来指示所使用仪器在试条2检测前其2上的反应物是否已充分渗移至试条检测带6和质控带7以适合所使用仪器能对试条检测带6和质控带7进行自动扫描，从而达到动态监测试条层析反应过程的成败细节。(3) Dynamic monitoring of the chromatographic reaction process of the test strip. 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. If the test strip fails to detect the test, 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.

(4)检测质量采用多重指标同步控制，使样品定量更精准：①试条2上设置质控带7，其光密度强度起检测对照作用。②存贮介质14存储相应被检物标准曲线或系数参数，用于定量相应被检物浓度。③存贮介质14存储试条质控带光密度参考监控值(OD_质控带)，用于监控样品检测中试条反应是否成立、提示检测结果是否有效。④试条2上设置试条反应终点指示标签，提示试条反应物在试条上的虹吸渗移层析是否充分，反应是否到达终点。(4) Detection quality 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. 2 The storage medium 14 stores a standard curve or coefficient parameter of the corresponding object for quantifying the concentration of the corresponding object. 3 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.

(5)所述试条卡卡盒3内的试条2为一次性使用试条；所述的用来现时插放一次性试条2的试条卡卡盒3及卡盒3上的存贮介质14为同批次试条2相配套的使用品。样品检测时，为节约检测者费用，同批次试条2可采取持续共用同批次试条2相配套的试条卡卡盒3来实施样品检测。试条2价格低廉，普通消费者都能承受。 (5) 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. In the sample test, in order to save the cost of the tester, 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.

(6)样品用量少，几微升至几十微升就能满足检测需要。(6) The sample dosage is small, and a few microliters to several tens of microliters can meet the detection needs.

(7)试条卡内试剂和材料不涉及活性失活，可于室温长期保存。(7) 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.

附图说明DRAWINGS

图l：本发明所述量子点标记试条卡优选方案一的俯视结构图(示其中即插试条采用一条检测线)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)

图2：本发明所述量子点标记试条卡优选方案一相配套的即插试条的侧视结构图(示试条采用一条检测线)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)

图3：本发明所述量子点标记试条卡优选方案一的俯视结构图(示其中即插试条采用多条检测线)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)

图4：本发明所述量子点标记试条卡优选方案一相配套的即插试条的侧视结构图(示试条采用多条检测线)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)

图5：本发明所述量子点标记试条卡另一优选方案的俯视结构图(示其中即插试条采用一条检测线)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)

图6：本发明所述量子点标记试条卡另一优选方案相配套的即插试条的侧视结构图(示试条采用一条检测线)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)

图7：本发明所述量子点标记试条卡另一优选方案的俯视结构图(示其中即插试条采用多条检测线)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)

图8：本发明所述量子点标记试条卡另一优选方案相配套的即插试条的侧视结构图(示试条采用多条检测线)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)

序号表示如下：The serial number is as follows:

1、底衬，2、试条，3、卡盒，4、吸样垫，5、标记垫，6、检测带，7、质控带，8、分析膜，9、吸水垫，10、试条反应终点指示标签，11、检测窗，12、观察窗，13、试条插槽口，14、存贮介质。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.

具体实施方式detailed description

下面实施例及其附图仅是为了进一步说明本发明，本领域人员不应以此限制本发明的保护范围。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.

实施例一 Embodiment 1

图1-4说明实施例一。实施例一为本发明所述量子点标记试条卡优选方案之一。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.

图1-4中，所述优选方案的所述量子点标记试条卡包括卡盒3和量子点标记试条2。所述量子点标记试条2包括顺次搭接固定在底衬1上的吸样垫4、标记垫5、分析膜8、吸水垫9。分析膜8具有检测带6和质控带7。卡盒3的一端连同该卡盒端的上盒面开口形成试条插槽口13，以方便量子点标记试条2能现时***卡盒3内。试条2为卡盒3的离式即插结构。样品检测时，插放到卡盒3内的试条2其吸样垫4一端过盈伸出卡盒3的开口端以浸渍吸取样品。卡盒3的上盒面在对应于试条分析膜8位置处开有检测窗11。卡盒3上安装有一存贮介质14。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 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.

所述量子点标记试条2的标记垫5包被有单一量子点标记的某一目标被检物检测相关的单一特异分子；或：包被有不同单一量子点对应标记的各目标被检物检测相关的特异分子的混合物。试条2标记垫5的所述单一量子点可选用以下颗粒，包括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中的任意一种或任意几种纳米粒子的组合，以及由上述任意一种量子点为核、二氧化硅为壳的核-壳型纳米复合粒子。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/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.

所述量子点标记试条2的检测带6可以为一条(图1和图2所示)，也可以为多条(图3和图4所示)。检测带6包被有某一目标被检物检测相关的另一特异分子；或：包被有各目标被检物检测相关的另一特异分子的混合物。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.

所述存贮介质14包括但不限于RFID标签、IC芯片、磁码、或条码等。其储存有同批次量子点标记试条2定量样品浓度用的被检物标准曲线或系数参数、试条质控带光密度参考监控值、试条批号、试条效期、存贮介质密码、临床指标参考值、试条生产厂商信息等，且可读入被测对象身份信息、检测者信息、样品名称、样品编号、检测日期、检测结果等信息。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.

所述量子点标记试条2的标记垫5为玻璃纤维膜；所述量子点标记试条2的分析膜8为硝酸纤维素膜、尼龙膜、或硝酸纤维素/醋酸纤维素混合膜；所述量子点标记试条2的底衬1为聚脂或塑料板；所述卡盒3为聚脂、塑料、硬性纸质材料、或其他材料做成。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.

所述量子点标记试条2为一次性使用品，所述卡盒3及卡盒3上的存贮介质14为同批次量子点标记试条2配套的使用品。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.

所述量子点标记试条卡用于样品检测时，其量子点标记试条2现时***卡盒3内，插放到卡盒3内的试条2的过盈伸出端浸渍吸取液体样品。液体样品在试条2上完成试条反应后，由具有信号检测功能的仪器(如读条仪、荧光检测仪等)采集试条2检测带6和质控带7的特征信号并结合该仪器从试条卡存贮介质14同时读取来的被检物标准曲线或系数参数而计算获得样品单组分或多组分浓度。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. After the liquid sample is subjected to the test strip reaction on the test strip 2, 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.

所述量子点标记试条卡的待检样品可以是来自临床或非临床的血液、体液、尿液、唾液、生殖道分泌物或其他液态样品或粘稠状样品，其中，临床样品包括传染病、激素、心血管病、肿瘤、癌症、糖尿病、自身免疫病等在内的样品，非临床样品包括食品检测、环境污染检测、农药残留量检测、生物沾染检测、生物制剂检测、兽医学检测、毒品检测等在内的样品。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.

实施例二 Embodiment 2

图5-8说明实施例二。实施例二为本发明所述量子点标记试条卡的另一优选方案。Figures 5-8 illustrate a second embodiment. Embodiment 2 is another preferred embodiment of the quantum dot marking strip card of the present invention.

图5-8中，所述优选方案的所述量子点标记试条卡包括卡盒3和量子点标记试条2。所述量子点标记试条2包括顺次搭接固定在底衬1上的吸样垫4、标记垫5、分析膜8、吸水垫9和试条反应终点指示标签10。分析膜8具有检测带6和质控带7。卡盒3的一端连同该卡盒端的上盒面开口形成试条插槽口13，以方便量子点标记试条2能现时***卡盒3内。试条 2为卡盒3的离式即插结构。样品检测时，插放到卡盒3内的试条2其吸样垫4一端过盈伸出卡盒3的开口端以浸渍吸取样品。卡盒3的上盒面在对应于试条分析膜8位置处开有检测窗11，卡盒3的上盒面在对应于试条反应终点指示标签10位置处开有观察窗12，卡盒3上安装有一存贮介质14。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 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.

所述量子点标记试条2的标记垫5包被有单一量子点标记的某一目标被检物检测相关的单一特异分子；或：包被有不同单一量子点对应标记的各目标被检物检测相关的特异分子的混合物。试条标记垫5的所述单一量子点可选用以下颗粒，包括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中的任意一种或任意几种纳米粒子的组合，以及由上述任意一种量子点为核、二氧化硅为壳的核-壳型纳米复合粒子。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. , 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.

所述量子点标记试条2的检测带6可以为一条(图5和图6所示)，也可以为多条(图7和图8所示)。检测带6包被有某一目标被检物检测相关的另一特异分子；或：包被有各目标被检物检测相关的另一特异分子的混合物。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.

所述试条反应终点指示标签10包括变色范围为5-9的pH试纸。样品检测时，试条上的试条反应终点指示标签10能根据试条反应的pH条件而显色，以提示试条反应物是否已充分渗移过检测带6和质控带7，提示试条反应是否充分，其检测结果是否有效。The strip reaction end point indicator 10 includes a pH test strip having a discoloration range of 5-9. When the sample is tested, 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.

所述量子点标记试条2为一次性使用品。所述卡盒3及卡盒3上的存贮介质14为同批次量子点标记试条2配套的使用品。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.

所述量子点标记试条卡用于样品检测时，其量子点标记试条2现时***卡盒3内，插放到卡盒3内的试条2的过盈伸出端浸渍吸取液体样品。试条反应终点指示标签10显色指示样品在试条2上完成试条反应后，由具有信号检测功能的仪器(如读条仪、荧光检测仪等)采集试条2检测带6和质控带7的特征信号并结合该仪器从试条卡存贮介质14同时读取来的被检物标准曲线或系数参数而计算获得样品单组分或多组分浓度。 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.

需要指出的是，本发明所述的量子点标记的试条卡还可以有其它改进，如存储有被检物标准曲线等检测用信息的存贮介质14除了安装在试条卡的卡盒3上外，还可直接安装在量子点标记试条2上；基于本发明相同原理，插放到卡盒3内的量子点标记试条还可扩展替换为量子点标记的生物芯片(包括抗原抗体芯片、蛋白芯片、核酸芯片、微流控芯片)等等。因此，凡是对本发明所述量子点标记试条卡采用任何等同替换或等效变换形成的其它技术方案，均落在本发明权利要求的保护范围中。 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 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.

Claims

一种量子点标记的试条卡，包括卡盒(3)和量子点标记试条(2)，量子点标记试条(2)包括顺次搭接固定在底衬(1)上的吸样垫(4)、标记垫(5)、分析膜(8)、吸水垫(9)，分析膜(8)具有检测带(6)和质控带(7)，检测带(6)为一条或多条，卡盒(3)的上盒面在对应于试条分析膜(8)位置处开有检测窗(11)，其特征在于：A quantum dot-labeled test strip card comprising a cartridge (3) and a quantum dot marking strip (2), the quantum dot marking strip (2) comprising a sample attached to the substrate (1) in a sequential overlap Pad (4), marking pad (5), analysis membrane (8), absorbent pad (9), analysis membrane (8) having a detection tape (6) and a quality control tape (7), and the detection tape (6) is one or a plurality of strips, the upper box surface of the cartridge (3) is provided with a detection window (11) at a position corresponding to the strip analysis film (8), which is characterized by:

所述卡盒(3)的一端连同该卡盒端的上盒面开口形成试条插槽口(13)，试条(2)为卡盒(3)的离式即插结构，样品检测时，插放到卡盒(3)内的试条(2)其吸样垫(4)一端过盈伸出卡盒(3)开口端以浸渍吸取样品；One end of the card box (3) and the upper box surface opening of the card box end form a test strip slot (13), and the test strip (2) is a separate plug-in structure of the card box (3), when the sample is tested, a test strip (2) inserted into the cartridge (3), one end of the suction pad (4) is over-extended to extend out of the open end of the cartridge (3) to dip the sample;

所述卡盒(3)上安装有一存贮介质(14)；The storage box (3) is mounted with a storage medium (14);

所述量子点标记试条(2)的标记垫(5)包被有单一量子点标记的某一目标被检物检测相关的单一特异分子，或：包被有不同单一量子点对应标记的各目标被检物检测相关的特异分子的混合物；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;

所述量子点标记试条(2)的检测带(6)包被有某一目标被检物检测相关的另一特异分子，或：包被有各目标被检物检测相关的另一特异分子的混合物；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;

所述量子点标记试条(2)的质控带(7)包被有包括二抗的质控物。The QC strip (7) of the quantum dot marking strip (2) is coated with a quality control comprising a secondary antibody.
根据权利要求1所述的量子点标记的试条卡，其特征在于：其中所述量子点标记试条(2)的标记垫(5)的所述单一量子点包括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中的任意一种或任意几种纳米粒子的组合，以及由上述任意一种量子点为核、二氧化硅为壳的核-壳型纳米复合粒子。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/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, 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 any one of the above quantum dots is a core, and silica is a shell Core-shell nanocomposite particles.
根据权利要求1所述的量子点标记的试条卡，其特征在于：所述存贮介质(14)包括RFID标签、IC芯片、磁码、或条码。The quantum dot-labeled test strip card of claim 1 wherein said storage medium (14) comprises an RFID tag, an IC chip, a magnetic code, or a barcode.
根据权利要求1所述的量子点标记的试条卡，其特征在于：所述存贮介质(14)储存有同批次量子点标记试条(2)定量样品浓度用的被检物标准曲线或系数参数、试条质控带光密度参考监控值、试条批号、试条效期、存贮介质密码、临床指标参考值、试条生产厂商信息，且可读入被测对象身份信息、检测者信息、样品名称、样品编号、检测日期、检测结果信息。The quantum dot-labeled test strip card according to claim 1, wherein said storage medium (14) stores the same batch of quantum dot-labeled test strips (2) a sample standard curve for quantitative sample concentration Or coefficient parameter, test strip quality control band optical density reference monitoring value, test strip batch number, test strip validity period, storage medium password, clinical index reference value, test strip manufacturer information, and can read the identity information of the measured object, Detector information, sample name, sample number, date of detection, and test result information.
根据权利要求4所述的量子点标记的试条卡，其特征在于：所述存贮介质(14)储存的被检物标准曲线有多种形式可供选择，其包括：被检物标准品系列浓度与OD_检测带/OD_质控带之间的对应关系曲线；或，被检物标准品系列浓度与OD_检测带/(OD_检测带+OD_质控带)之间的对应关系曲线；其中，OD_检测带为被检物标准品系列浓度测得的检测带光密度值，OD_质控带为被检物标准品系列浓度测得的质控带光密度值。 The quantum dot-labeled test strip card according to claim 4, wherein the standard curve of the test object stored in the storage medium (14) has various forms to be selected, including: a test object standard product Corresponding relationship between the concentration of the series and the OD _{detection zone} /OD _{control zone} ; or the corresponding relationship between the concentration of the standard sample and the OD _{detection zone} /(OD _{detection zone} + OD _{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, and the OD _{quality control zone} is the quality control zone optical density value measured by the concentration of the standard sample of the test object.
根据权利要求1所述的量子点标记的试条卡，其特征在于：The quantum dot-labeled test strip card according to claim 1, wherein:

所述量子点标记试条(2)的标记垫(5)为玻璃纤维膜，所述量子点标记试条(2)的分析膜(8)为硝酸纤维素膜、尼龙膜、或硝酸纤维素/醋酸纤维素混合膜；The marking pad (5) of the quantum dot marking strip (2) is a glass fiber membrane, and the analysis membrane (8) of the quantum dot marking strip (2) is a nitrocellulose membrane, a nylon membrane, or a nitrocellulose. / cellulose acetate mixed film;

所述量子点标记试条(2)的底衬(1)为聚脂或塑料板；The underlayer (1) of the quantum dot marking strip (2) is a polyester or plastic plate;

所述卡盒(3)为聚脂、塑料、或硬性纸质材料做成。The cartridge (3) is made of polyester, plastic, or a hard paper material.
根据权利要求1所述的量子点标记的试条卡，其特征在于：其中所述量子点标记试条(2)为一次性使用品，所述卡盒(3)及卡盒(3)上的存贮介质(14)为同批次量子点标记试条(2)配套的使用品。The quantum dot-labeled test strip card according to claim 1, wherein said quantum dot marking test strip (2) is a disposable product, said cartridge (3) and said cartridge (3) The storage medium (14) is used for the same batch of quantum dot marking strips (2).
根据权利要求1所述的量子点标记的试条卡，其特征在于：样品检测时，量子点标记试条(2)现时***卡盒(3)内，插放到卡盒(3)内的试条(2)的过盈伸出端浸渍吸取样品，样品在试条(2)上完成试条反应后，由具有信号检测功能的仪器采集卡盒(3)内试条(2)检测带(6)和质控带(7)的特征信号并结合该仪器从存贮介质(14)同时读取的被检物标准曲线或系数参数而计算获得样品单组分或多组分浓度。The quantum dot-labeled test strip card according to claim 1, wherein when the sample is detected, the quantum dot marking test strip (2) is currently inserted into the cartridge (3) and inserted into the cartridge (3). The interference protruding end of the test strip (2) is immersed to suck the sample, and after the sample is reacted on the test strip (2), the test strip is collected by the instrument with the signal detection function (3) the inner test strip (2) the test strip (6) The characteristic signal of the quality control tape (7) is combined with the standard curve or coefficient parameter of the test object simultaneously read by the instrument from the storage medium (14) to calculate the single component or multi-component concentration of the sample.
一种如权利要求1所述的量子点标记的试条卡，其特征在于：其中所述量子点标记试条(2)的吸水垫(9)之后还搭接有一试条反应终点指示标签(10)；其卡盒(3)的该试条反应终点指示标签(10)相应处开有观察窗(12)。A quantum dot-labeled test strip card according to claim 1, wherein the water-absorbing pad (9) of the quantum dot-labeled test strip (2) is further overlapped with a test strip reaction end point indicator label ( 10); the test strip reaction end label (10) of the cartridge (3) has an observation window (12) corresponding thereto.
根据权利要求9所述的量子点标记的试条卡，其特征在于，所述试条反应终点指示标签(10)包括变色范围为5-9的pH试纸。The quantum dot-labeled test strip card according to claim 9, wherein the test strip reaction end point indicating label (10) comprises a pH test paper having a discoloration range of 5-9.
根据权利要求9所述的量子点标记的试条卡，其特征在于：其中所述量子点标记试条(2)的标记垫(5)的所述单一量子点包括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中的任意一种或任意几种纳米粒子的组合，以及由上述任意一种量子点为核、二氧化硅为壳的核-壳型纳米复合粒子。The quantum dot-labeled test strip card according to claim 9, 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/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, 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 any one of the above quantum dots is a core, and silica is a shell Core-shell nanocomposite particles.
根据权利要求9所述的量子点标记的试条卡，其特征在于：所述存贮介质(14)包括RFID标签、IC芯片、磁码、或条码。A quantum dot-labeled test strip card according to claim 9, wherein said storage medium (14) comprises an RFID tag, an IC chip, a magnetic code, or a barcode.
根据权利要求9所述的量子点标记的试条卡，其特征在于：所述存贮介质(14)储存有同批次量子点标记试条(2)定量样品浓度用的被检物标准曲线或系数参数、试条质控带光密度参考监控值、试条批号、试条效期、存贮介质密码、临床指标参考值、试条生产厂商信息，且可读入被测对象身份信息、检测者信息、样品名称、样品编号、检测日期、检测结果信息。The quantum dot-labeled test strip card according to claim 9, wherein said storage medium (14) stores the same batch of quantum dot-labeled test strips (2) a sample standard curve for quantitative sample concentration Or coefficient parameter, test strip quality control band optical density reference monitoring value, test strip batch number, test strip validity period, storage medium password, clinical index reference value, test strip manufacturer information, and can read the identity information of the measured object, Detector information, sample name, sample number, date of detection, and test result information.
根据权利要求13所述的量子点标记的试条卡，其特征在于：所述存贮介质(14)储存的被检物标准曲线有多种形式可供选择，其包括：被检物标准品系列浓度与OD_检测带/OD_质 _控带之间的对应关系曲线；或，被检物标准品系列浓度与OD_检测带/(OD_检测带+OD_质控带)之间的对应关系曲线；其中，OD_检测带为被检物标准品系列浓度测得的检测带光密度值，OD_质控带为被检物标准品系列浓度测得的质控带光密度值。The quantum dot-labeled test strip card according to claim 13, wherein the standard curve of the test object stored in the storage medium (14) has various forms to be selected, including: the test object standard product correspondence or relationship between the curves, the concentration of the analyte and standard _{OD test} series / _{(OD test} line + _{OD control);;} _{OD test} series and concentration / OD _{_{mass-controlled}} correspondence between the _band curve wherein 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, and the OD _{quality control zone} is the quality control zone optical density value measured by the concentration of the standard sample of the test object.
根据权利要求9所述的量子点标记的试条卡，其特征在于：The quantum dot-labeled test strip card according to claim 9, wherein:

所述量子点标记试条(2)的标记垫(5)为玻璃纤维膜，所述量子点标记试条(2)的分析膜(8)为硝酸纤维素膜、尼龙膜、或硝酸纤维素/醋酸纤维素混合膜；The marking pad (5) of the quantum dot marking strip (2) is a glass fiber membrane, and the analysis membrane (8) of the quantum dot marking strip (2) is a nitrocellulose membrane, a nylon membrane, or a nitrocellulose. / cellulose acetate mixed film;

所述量子点标记试条(2)的底衬(1)为聚脂或塑料板；The underlayer (1) of the quantum dot marking strip (2) is a polyester or plastic plate;

所述卡盒(3)为聚脂、塑料、或硬性纸质材料做成。The cartridge (3) is made of polyester, plastic, or a hard paper material.
根据权利要求9所述的量子点标记的试条卡，其特征在于：其中所述量子点标记试条(2)为一次性使用品，所述卡盒(3)及卡盒(3)上的存贮介质(14)为同批次量子点标记试条(2)配套的使用品。The quantum dot-labeled test strip card according to claim 9, wherein said quantum dot marking test strip (2) is a disposable product, said cartridge (3) and said cartridge (3) The storage medium (14) is used for the same batch of quantum dot marking strips (2).
根据权利要求9所述的量子点标记的试条卡，其特征在于：样品检测时，量子点标记试条(2)现时***卡盒(3)内，插放到卡盒(3)内的试条(2)的过盈伸出端浸渍吸取样品，试条反应终点指示标签(10)指示样品在试条(2)上完成试条反应后，由具有信号检测功能的仪器采集卡盒(3)内试条(2)检测带(6)和质控带(7)的特征信号并结合该仪器从存贮介质(14)同时读取的被检物标准曲线或系数参数而计算获得样品单组分或多组分浓度。The quantum dot-labeled test strip card according to claim 9, wherein when the sample is detected, the quantum dot marking test strip (2) is currently inserted into the cartridge (3) and inserted into the cartridge (3). The interference protruding end of the test strip (2) is immersed to suck the sample, and the test strip reaction end indication label (10) indicates that after the sample is reacted on the test strip (2), the cassette is collected by the instrument having the signal detecting function ( 3) The inner test strip (2) detects the characteristic signal of the strip (6) and the quality control strip (7) and calculates the sample by combining the standard curve or coefficient parameter of the sample simultaneously read by the instrument from the storage medium (14). Single or multi-component concentration.
一种如权利要求1或9所述的量子点标记的试条卡，其特征在于：待检样品是来自临床或非临床的血液、体液、尿液、唾液、生殖道分泌物或其他液态样品或粘稠状样品，其中，临床样品包括传染病、激素、心血管病、肿瘤、癌症、糖尿病、自身免疫病在内的样品，非临床样品包括食品检测、环境污染检测、农药残留量检测、生物沾染检测、生物制剂检测、兽医学检测、毒品检测在内的样品。 A quantum dot-labeled test strip according to claim 1 or 9, wherein the sample to be tested is from clinical or non-clinical blood, body fluid, urine, saliva, genital secretions or other liquid samples. Or viscous samples, including clinical samples including infectious diseases, hormones, cardiovascular diseases, tumors, cancer, diabetes, autoimmune diseases, non-clinical samples including food testing, environmental pollution testing, pesticide residue testing, Samples for bio-contamination testing, biologics testing, veterinary testing, and drug testing.