WO2015070703A1 - 一种试条卡 - Google Patents

一种试条卡 Download PDF

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Publication number
WO2015070703A1
WO2015070703A1 PCT/CN2014/089637 CN2014089637W WO2015070703A1 WO 2015070703 A1 WO2015070703 A1 WO 2015070703A1 CN 2014089637 W CN2014089637 W CN 2014089637W WO 2015070703 A1 WO2015070703 A1 WO 2015070703A1
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WIPO (PCT)
Prior art keywords
test strip
strip
sample
test
detection
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PCT/CN2014/089637
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English (en)
French (fr)
Inventor
马义才
顾敏
马灵
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成都领御生物技术有限公司
马义才
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Application filed by 成都领御生物技术有限公司, 马义才 filed Critical 成都领御生物技术有限公司
Publication of WO2015070703A1 publication Critical patent/WO2015070703A1/zh

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G01N33/4875—Details of handling test elements, e.g. dispensing or storage, not specific to a particular test method
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/558—Immunoassay; Biospecific binding assay; Materials therefor using diffusion or migration of antigen or antibody
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/58—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving labelled substances
    • G01N33/588—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving labelled substances with semiconductor nanocrystal label, e.g. quantum dots
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases

Definitions

  • the invention belongs to the field of in vitro diagnosis, and particularly relates to a test information such as a standard curve or a coefficient parameter for storing a test object with a storage medium 12, and an instrument with a signal detection function can quickly detect a single component or a plurality of groups of samples.
  • the test strip card is a standard curve or a coefficient parameter for storing a test object with a storage medium 12, and an instrument with a signal detection function can quickly detect a single component or a plurality of groups of samples.
  • Immunochromatographic strip technology which is mainly represented by colloidal gold strips, has been widely used in various aspects of immunoassays.
  • the technology is simple and fast, and results are available in minutes.
  • the inadequacies are: (1) Only qualitative detection of samples, it is difficult to achieve quantitative detection of samples, it is more difficult to achieve rapid quantitative detection of multi-component samples. (2) For samples with very low antigen or antibody content, it is difficult to judge the results with the naked eye and the detection sensitivity is low.
  • the use of the standard curve of the test substance to quantify the concentration of the test substance is the main method for quantifying the concentration of the sample in the current detection field.
  • the standard curve is technically strong and the process is complicated, and it is inseparable from professional technicians.
  • 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.
  • RFID tags small size, large storage capacity, identification without manual intervention, is an ideal means of information access identification, but few people use it in biomedical testing.
  • the present invention provides a test information such as a standard curve or a coefficient parameter for storing a test object with a storage medium 12 (the operator does not need to make a standard curve of the test object when detecting the sample)
  • a test information such as a standard curve or a coefficient parameter for storing a test object with a storage medium 12 (the operator does not need to make a standard curve of the test object when detecting the sample)
  • an instrument with signal detection function it is possible to quickly realize a one-component or multi-component quantitative (qualitative/semi-quantitative) test strip.
  • the invention is used for sample detection, and has the characteristics of simple and rapid, high sensitivity and objective result.
  • the test strip card of the present invention comprises a cartridge 3 and a test strip 2 therein.
  • the test strip 2 includes a sample pad 4, a marker pad 5, an analysis film 8, and an absorbent pad 9 which are fixed to the substrate 1 in this order.
  • the analysis membrane 8 has a detection strip 6 and a quality control strip 7.
  • the upper casing of the cartridge 3 is provided with a sample insertion hole 10 at a position corresponding to the test strip 4 of the test strip.
  • 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 12 is mounted on the cartridge 3.
  • the marker pad 5 of the test strip 2 is coated with a single specific molecule associated with a target analyte detected by a single marker, or a specific one associated with each target analyte coated with a marker corresponding to a different marker. a mixture of molecules.
  • the test strip 6 of the test strip 2 may be one piece or a plurality of strips.
  • the test strip 6 is coated with another specific molecule associated with detection of a target analyte, or a mixture of another specific molecule coated with detection of each target analyte.
  • the quality control strip 7 of the test strip 2 is coated with a quality control.
  • the control includes a secondary antibody.
  • the storage medium 12 on the cartridge 3 includes, but is not limited to, an RFID tag, an IC chip, a magnetic code, or a barcode.
  • the storage medium 12 stores the standard curve or coefficient parameter of the sample for the quantitative sample concentration of the same batch of test strips 2, the reference monitoring value of the test strip quality control belt signal strength, the test strip batch number, the test strip validity period, the storage medium password , clinical indicator reference value, test strip manufacturer information, etc., and can read the object identification information, tester information, sample name, sample number, date of detection, test results and other information.
  • the standard curve of the object stored in the storage medium 12 can be selected in various forms, including but not limited to the following curve: the correspondence between the concentration of the standard of the object to be tested and the A detection zone / A quality control zone Relationship curve; or, the relationship between the concentration of the sample standard series and the A detection zone / (A detection zone + A quality control zone ).
  • the A detection zone is the signal intensity of the detection zone measured by the concentration of the standard product of the test object
  • the A control zone is the signal intensity of the quality control zone measured by the concentration of the standard product of the test object.
  • a test strip reaction end indicating label 13 can be overlapped.
  • the test strip reaction end point of the cartridge 3 indicates that the label 13 is open corresponding to the observation window 14.
  • the strip reaction end point indicating label 13 includes, but is not limited to, a pH test paper having a discoloration range of 5-9.
  • the marking pad 5 of the test strip 2 of the present invention is a glass fiber membrane;
  • the analytical membrane 8 of the test strip 2 is a nitrocellulose membrane, a nylon membrane, or a nitrocellulose/cellulose acetate mixed membrane;
  • the backing 1 is a polyester or plastic plate;
  • the cartridge 3 is made of polyester, plastic, hard paper material, or other material.
  • the test strip 2 of the present invention is any test strip, including but not limited to a quantum dot label test strip, a colloidal gold label test strip, a colloidal selenium label strip, an upconversion phosphor label strip, and a nano rare earth fluorescent complex labeling test. Strips, nano-magnetic particle labeling strips, time-resolved chromatographic strips, chemiluminescent strips.
  • the test strip of the present invention is used to collect the test strip 2 detection belt 6 by an instrument having a signal detection function (such as a reading instrument, a fluorescence detector, a magnetic signal detector, etc.) after the test strip is completed. And determining the one-component or multi-component concentration of the sample by combining the characteristic signal of the quality control tape 7 with the standard curve or coefficient parameter of the test object simultaneously read by the instrument from the storage medium 12; or, according to the test strip The strip test strip 6 and the control strip 7 are displayed to determine the sample composition qualitatively or semi-quantitatively.
  • a signal detection function such as a reading instrument, a fluorescence detector, a magnetic signal detector, etc.
  • the sample to be tested of the test strip card of the present invention may be from clinical or non-clinical blood, body fluid, urine, saliva, genital secretions or other liquid samples or viscous samples, wherein the clinical samples include infectious diseases, Samples of 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 testing, drugs Samples such as detection.
  • a storage medium 12 is mounted on the test strip card of the present invention, and the storage medium 12 stores detection information such as a standard curve or a coefficient parameter of the test object.
  • detection information such as a standard curve or a coefficient parameter of the test object.
  • Quantum Dots are semiconductor nanocrystals with excellent spectral characteristics and photochemical stability developed in the 1990s. They have high fluorescence emission efficiency, wide excitation line range, narrow emission line range, and fluorescence. It has a long life, large Stokes displacement, similar particle size to biomolecules, and multi-functionality after surface modification. Quantum dots of different particle sizes, types and structures can produce sustained fluorescence peak spectra with different characteristic wavelengths, and the characteristic wavelength fluorescence peak spectra produced by the quantum dot mixture do not overlap.
  • the corresponding reaction molecules of the test object are respectively labeled by using different quantum dots, and the mixture is coated on the test strip of the test strip of the present invention to react with the sample to be tested, and the specific fluorescent signal of the test strip can be measured within a few minutes.
  • the existing test strip technology can only qualitatively detect samples, and can not achieve quantitative detection of samples, and can not achieve quantitative detection of multi-component samples.
  • the reagents and materials in the test strip are not involved in activity inactivation and can be stored at room temperature for a long time.
  • Figure 1 is a top plan view of a preferred embodiment of the test strip card of the present invention (showing a test line in the inner test strip)
  • Figure 2 is a side view showing the structure of the test strip in the cartridge of the first preferred embodiment of the strip card of the present invention (the test strip adopts a test line)
  • Figure 3 is a top plan view of a preferred embodiment of the test strip card of the present invention (showing a plurality of test lines in the test strip)
  • Figure 4 is a side view showing the structure of the test strip in the cartridge of the first preferred embodiment of the test strip card of the present invention (the test strip adopts a plurality of test lines)
  • Figure 5 is a top plan view of another preferred embodiment of the test strip of the present invention (showing a test line in the test strip)
  • Figure 6 is a side view showing the structure of the test strip in another embodiment of the test strip card of the present invention (the test strip adopts a test line)
  • Figure 7 is a top plan view of another preferred embodiment of the test strip card of the present invention (showing a plurality of test lines in the test strip)
  • FIG. 8 is a side view structural view of a test strip in a cartridge according to another preferred embodiment of the test strip card of the present invention (the test strip adopts a plurality of detection lines)
  • test strip 1, underlay, 2, test strip, 3, cartridge, 4, sample pad, 5, marker pad, 6, test tape, 7, quality control tape, 8, analytical film, 9, absorbent pad, 10, sample loading Hole, 11, detection window, 12, storage medium, 13, test strip reaction end indication label, 14, observation window.
  • Embodiment 1 is one of the preferred embodiments of the test strip card of the present invention.
  • the strip card of the preferred embodiment includes a cartridge 3 and a strip 2 therein.
  • the 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 laps.
  • the analysis membrane 8 has a detection strip 6 and a quality control strip 7.
  • the upper casing of the cartridge 3 is provided with a sample insertion hole 10 at a position corresponding to the test strip 4 of the test strip.
  • 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 12 is mounted on the cartridge 3.
  • the marker pad 5 of the test strip 2 is coated with a single specific molecule associated with a target analyte detected by a single marker, or a specific one associated with each target analyte coated with a marker corresponding to a different marker. a mixture of molecules.
  • the test strip 6 of the test 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 quality control strip 7 of the test strip 2 is coated with a quality control.
  • the control includes a secondary antibody.
  • the storage medium 12 on the cartridge 3 includes, but is not limited to, an RFID tag, an IC chip, a magnetic code, or a barcode.
  • the storage medium 12 stores the standard curve or coefficient parameter of the sample for the quantitative sample concentration of the same batch of test strips 2, the reference monitoring value of the test strip quality control belt signal strength, the test strip batch number, the test strip validity period, the storage medium password , clinical indicator reference value, test strip manufacturer information, etc., and can read the object identification information, tester information, sample name, sample number, date of detection, test results and other information.
  • the standard curve of the sample stored in the storage medium 12 can be selected in various forms, including but not limited to the following curves: the correspondence between the concentration of the sample standard series and the A detection zone /A quality control zone Relationship curve; or, the relationship between the concentration of the sample standard series and the A detection zone / (A detection zone + A quality control zone ).
  • the A detection zone is the signal intensity of the detection zone measured by the concentration of the standard product of the test object
  • the A control zone is the signal intensity of the quality control zone measured by the concentration of the standard product of the test object.
  • the marking pad 5 of the test strip 2 is a glass fiber membrane; the analytical membrane 8 of the test strip 2 is a nitrocellulose membrane, a nylon membrane, or a nitrocellulose/cellulose acetate mixed membrane; the bottom of the test strip 2
  • the liner 1 is a polyester or plastic plate; the cartridge 3 is made of polyester, plastic, hard paper material, or other material.
  • the test strip 2 is any test strip, including but not limited to a quantum dot label test strip, a colloidal gold label test strip, and a colloidal selenium label.
  • the test strip, the upconversion phosphor labeling strip, the nano rare earth fluorescent complex labeling strip, the nano magnetic particle labeling strip, the time-resolved chromatographic strip, and the chemiluminescent strip are any test strip, including but not limited to a quantum dot label test strip, a colloidal gold label test strip, and a colloidal selenium label.
  • the test strip, the upconversion phosphor labeling strip, the nano rare earth fluorescent complex labeling strip, the nano magnetic particle labeling strip, the time-resolved chromatographic strip, and the chemiluminescent strip are examples of the chemiluminescent strip.
  • the liquid sample is applied to the sample hole 10 of the test strip card, and after the inner test strip 2 completes the reaction, the instrument with signal detection function (such as a reading instrument, fluorescence)
  • the detector, the magnetic signal detector, etc. collect the characteristic signals of the test strip 2 detection strip 6 and the quality control strip 7 and combine the standard curve or coefficient parameter of the test object simultaneously read from the test strip card storage medium 12 by the instrument.
  • the single component or multi-component concentration of the sample is quantitatively obtained; or, the sample component is qualitatively or semi-quantitatively determined according to the display condition of the test strip 6 and the control strip 7 of the test strip card.
  • the sample to be tested of the test strip card may be from clinical or non-clinical blood, body fluid, urine, saliva, genital secretions or other liquid samples or viscous samples, wherein the clinical samples include infectious diseases, hormones, Samples of cardiovascular disease, cancer, cancer, diabetes, autoimmune diseases, etc., non-clinical samples including food testing, environmental pollution testing, pesticide residue testing, biological contamination testing, biological agent testing, veterinary testing, drug testing, etc.
  • Embodiment 2 is another preferred embodiment of the test strip card of the present invention.
  • the strip card of the preferred embodiment includes a cartridge 3 and a strip 2 therein.
  • the test strip 2 includes a sample pad 4, a marker pad 5, an analysis film 8, an absorbent pad 9, and a test strip reaction end indicating label 13 which are sequentially attached to the substrate 1.
  • the analysis membrane 8 has a detection strip 6 and a quality control strip 7.
  • the upper casing of the cartridge 3 is provided with a sample insertion hole 10 at a position corresponding to the test strip 4 of the test strip.
  • 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.
  • the upper casing of the cartridge 3 is provided with an observation window 14 at a position corresponding to the test strip end point indicating label 13.
  • a storage medium 12 is mounted on the cartridge 3.
  • the marker pad 5 of the test strip 2 is coated with a single specific molecule associated with a target analyte detected by a single marker, or a specific one associated with each target analyte coated with a marker corresponding to a different marker. a mixture of molecules.
  • the test strip 6 of the test 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 quality control strip 7 of the test strip 2 is coated with a quality control.
  • the control includes a secondary antibody.
  • the strip reaction end point indicating label 13 includes, but is not limited to, a pH test paper having a discoloration range of 5-9.
  • the end point of the test strip on the test strip indicates that the label 13 can be colored according to the pH condition of the reaction of the strip to indicate whether the strip reaction has sufficiently oozing through the strip 6 and the control strip 7, prompting the test Whether the strip reaction is sufficient and whether the test result is valid.
  • the storage medium 12 on the cartridge 3 includes, but is not limited to, an RFID tag, an IC chip, a magnetic code, or a barcode.
  • the storage medium 12 stores the standard curve or coefficient parameter of the sample for the quantitative sample concentration of the same batch of test strips 2, the reference monitoring value of the test strip quality control belt signal strength, the test strip batch number, the test strip validity period, the storage medium password , clinical indicator reference value, test strip manufacturer information, etc., and can read the object identification information, tester information, sample name, sample number, date of detection, test results and other information.
  • the standard curve of the sample stored in the storage medium 12 can be selected in various forms, including but not limited to the following curves: the correspondence between the concentration of the sample standard series and the A detection zone /A quality control zone Relationship curve; or, the relationship between the concentration of the sample standard series and the A detection zone / (A detection zone + A quality control zone ).
  • the A detection zone is the signal intensity of the detection zone measured by the concentration of the standard product of the test object
  • the A control zone is the signal intensity of the quality control zone measured by the concentration of the standard product of the test object.
  • the marking pad 5 of the test strip 2 is a glass fiber membrane; the analytical membrane 8 of the test strip 2 is a nitrocellulose membrane, a nylon membrane, or a nitrocellulose/cellulose acetate mixed membrane; the bottom of the test strip 2
  • the liner 1 is a polyester or plastic plate; the cartridge 3 is made of polyester, plastic, hard paper material, or other material.
  • the test strip 2 is any test strip, which includes, but is not limited to, a quantum dot label test strip, a colloidal gold label test strip, a colloidal selenium label strip, an upconversion phosphor label strip, a nano rare earth fluorescent complex label strip, Nano magnetic particle labeling strip, time-resolved chromatographic strip, chemiluminescent strip.
  • the liquid sample is applied to the sample hole 10 of the test strip card, and the test strip reaction end point label 13 of the inner test strip 2 indicates that the sample is finished on the test strip 2
  • the instrument with the signal detection function (such as the reading instrument, the fluorescence detector, the magnetic signal detector, etc.) collects the characteristic signals of the test strip 2 detection strip 6 and the quality control strip 7 and combines the instrument from the test strip card storage medium. 12 simultaneously reading the standard curve or coefficient parameter of the test object to quantitatively obtain the single component or multi-component concentration of the sample; or, according to the test strip of the test strip, the detection band 6 and the control tape 7 are displayed. Qualitative or semi-quantitative detection of sample components.
  • the sample to be tested of the test strip card may be from clinical or non-clinical blood, body fluid, urine, saliva, genital secretions or other liquid samples or viscous samples, wherein the clinical samples include infectious diseases, hormones, Samples of cardiovascular disease, cancer, cancer, diabetes, autoimmune diseases, etc., non-clinical samples including food testing, environmental pollution testing, pesticide residue testing, biological contamination testing, biological agent testing, veterinary testing, drug testing, etc.
  • the test strip card of the present invention may have other improvements.
  • the storage medium 12 storing the detection information such as the standard curve of the test object may be mounted on the cartridge 3 of the test strip card.
  • the test strip in the cartridge 3 can also be expanded and replaced with a biochip (including an antigen-antibody chip, a protein chip, a nucleic acid chip, a microfluidic chip), etc. Wait. Therefore, any other technical solutions formed by any equivalent replacement or equivalent transformation of the test strip of the present invention fall within the scope of protection of the present invention.

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Abstract

一种自身带有存贮介质（12）以存储被检物标准曲线或系数参数信息的试条卡，包括卡盒（3）和其内的试条（2）；存贮介质（12）安装在卡盒（3）上。样品检测时，试条卡由具有信号检测功能的仪器采集其内试条（2）的检测带（6）和质控带（7）特征信号并结合仪器从存贮介质（12）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份或多组份浓度。具有简便快速、灵敏度高、结果客观、使用灵活的特点。

Description

一种试条卡 技术领域
本发明属于体外诊断领域，具体涉及一种自身带有存贮介质12备储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检测样品单一组分或多组分的试条卡。
背景技术
以胶体金试条为主要代表的免疫层析试条技术现已广泛用于免疫检测的各个方面。该技术简单快速，几分钟就能获得结果。不足之处是：(1)只能定性检测样品，难能实现样品定量检测，更难实现样品多组分快速定量检测。(2)对于某些抗原或抗体含量极低的样本，很难用肉眼判断结果，检测灵敏度低。
采用被检物标准品标准曲线定量被检物浓度，是目前检测领域定量样品浓度的主要方法。标准曲线制作技术性强，过程繁杂，离不开专业技术人员。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。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，但很少有人将其用于生物医学检测领域。
为克服现有技术的不足，本发明提供一种自身带有存贮介质12备储被检物标准曲线或系数参数等检测用信息(操作人员检测样品时勿需再制作被检物标准曲线)、结合具有信号检测功能的仪器就能快速实现样品单组分或多组分定量(定性/半定量)检测的试条卡。本发明用于样品检测，具有简便快速、灵敏度高、结果客观等特点。
发明内容
本发明技术方案如下：
本发明所述试条卡包括卡盒3和其内的试条2。试条2包括顺次搭接固定在底衬1上的样品垫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的上盒面在对应于试条样品垫4位置处开有加样孔10。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12。
所述试条2的标记垫5包被有单一标记物标记的某一目标被检物检测相关的单一特异分子，或：包被有不同标记物对应标记的各目标被检物检测相关的特异分子的混合物。
所述试条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。
所述试条2的质控带7包被有质控物。所述质控物包括二抗。
所述卡盒3上的存贮介质12包括但不限于RFID标签、IC芯片、磁码、或条码等。存贮介质12储存有同批次试条2定量样品浓度用的被检物标准曲线或系数参数、试条质控带信号强度参考监控值、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。
所述存贮介质12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A检测带/A质控带之间的对应关系曲线；或，被检物标准品系列浓度与A检测带/(A检测带+A质控带)之间的对应关系曲线。其中，A检测带为被检物标准品系列浓度测得的检测带信号强度，A质控带为被检物标准品系列浓度测得的质控带信号强度。
本发明所述试条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13。相应地，其卡盒3的该试条反应终点指示标签13对应处开有观察窗14。所述试条反应终点指示标签13包括但不限于变色范围为5-9的pH试纸。
本发明所述试条2的标记垫5为玻璃纤维膜；所述试条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。
本发明所述试条2为任何试条，其包括但不限于量子点标记试条、胶体金标记试条、胶体硒标记试条、上转换磷光物标记试条、纳米稀土荧光配合物标记试条、纳米磁性颗粒标记试条、时间分辨层析试条、化学发光试条。
本发明所述试条卡在试条被检物完成试条反应后，由具有信号检测功能的仪器(如读条仪、荧光检测仪、磁信号检测仪等)采集其试条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12同时读取来的被检物标准曲线或系数参数而定量获得样品单组分或多组分浓度；或，根据所述试条卡的试条检测带6和质控带7的显示情况而定性或半定量检测样品组分。
本发明所述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。
本发明具有如下有益效果：
(1)可快速定量检测样品组分(包括定性或半定量检测样品组分)。本发明所述试条卡上安装有存贮介质12，该存贮介质12储存有被检物标准曲线或系数参数等检测用信息。当待测样品在试条上完成层析反应后，由具有信号检测功能的仪器采集试条卡内试条2的检测带6和质控带7特征信号并结合该仪器从存贮介质12同时读取来的被检物标准曲线或系数参数即可快速(几分钟内)定量获得样品组分浓度。
(2)本发明所述试条卡内的试条2当采用量子点标记时，能同时实现样品多组分快速准确定量检测。量子点(Quantum Dots，简称QDs)是20世纪90年代发展的一种具优良光谱特征和光化学稳定性的半导体纳米晶体，具有荧光发光效率高，激发谱线范围宽，发射谱线范围窄，荧光寿命长，Stokes位移大，粒径与生物分子相近，表面修饰后能多功能化等特点。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峰谱，且量子点混合物产生的特征波长荧光峰谱不交叠。采用不同量子点分别标记被检物相应反应分子，将其混合物包被在本发明所述试条卡的试条上与待测样品进行反应，通过测定试条特定荧光信号，几分钟内就能快速准确定量样品多组分浓度。而现有试条技术则只能定性检测样品，不能实现样品定量检测，更不能实现样品多组分定量检测。
(3)所述试条卡内试剂和材料不涉及活性失活，可于室温长期保存。
附图说明
图l：本发明所述试条卡优选方案一的俯视结构图(示其内试条采用一条检测线)
图2：本发明所述试条卡优选方案一的卡盒内试条的侧视结构图(示试条采用一条检测线)
图3：本发明所述试条卡优选方案一的俯视结构图(示其内试条采用多条检测线)
图4：本发明所述试条卡优选方案一的卡盒内试条的侧视结构图(示试条采用多条检测线)
图5：本发明所述试条卡另一优选方案的俯视结构图(示其内试条采用一条检测线)
图6：本发明所述试条卡另一优选方案的卡盒内试条的侧视结构图(示试条采用一条检测线)
图7：本发明所述试条卡另一优选方案的俯视结构图(示其内试条采用多条检测线)
图8：本发明所述试条卡另一优选方案的卡盒内试条的侧视结构图(示试条采用多条检测线)
序号表示如下：
1、底衬，2、试条，3、卡盒，4、样品垫，5、标记垫，6、检测带，7、质控带，8、分析膜，9、吸水垫，10、加样孔，11、检测窗，12、存贮介质，13、试条反应终点指示标签，14、观察窗。
具体实施方式
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。
实施例一
图1-4说明实施例一。实施例一为本发明所述试条卡优选方案之一。
图1-4中，所述优选方案的所述试条卡包括卡盒3和其内的试条2。所述试条2包括顺次搭接固定在底衬1上的样品垫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的上盒面在对应于试条样品垫4位置处开有加样孔10。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12。
所述试条2的标记垫5包被有单一标记物标记的某一目标被检物检测相关的单一特异分子，或：包被有不同标记物对应标记的各目标被检物检测相关的特异分子的混合物。
所述试条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。
所述试条2的质控带7包被有质控物。所述质控物包括二抗。
所述卡盒3上的存贮介质12包括但不限于RFID标签、IC芯片、磁码、或条码等。存贮介质12储存有同批次试条2定量样品浓度用的被检物标准曲线或系数参数、试条质控带信号强度参考监控值、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。
所述存贮介质12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A检测带/A质控带之间的对应关系曲线；或，被检物标准品系列浓度与A检测带/(A检测带+A质控带)之间的对应关系曲线。其中，A检测带为被检物标准品系列浓度测得的检测带信号强度，A质控带为被检物标准品系列浓度测得的质控带信号强度。
所述试条2的标记垫5为玻璃纤维膜；所述试条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。
所述试条2为任何试条，其包括但不限于量子点标记试条、胶体金标记试条、胶体硒标 记试条、上转换磷光物标记试条、纳米稀土荧光配合物标记试条、纳米磁性颗粒标记试条、时间分辨层析试条、化学发光试条。
所述试条卡用于样品检测时，液体样品被施加到试条卡的加样孔10中，待其内试条2完成反应后，由具有信号检测功能的仪器(如读条仪、荧光检测仪、磁信号检测仪等)采集其试条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12同时读取来的被检物标准曲线或系数参数而定量获得样品单组分或多组分浓度；或，根据所述试条卡的试条检测带6和质控带7的显示情况而定性或半定量检测样品组分。
所述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。
实施例二
图5-8说明实施例二。实施例二为本发明所述试条卡的另一优选方案。
图5-8中，所述优选方案的所述试条卡包括卡盒3和其内的试条2。所述试条2包括顺次搭接固定在底衬1上的样品垫4、标记垫5、分析膜8、吸水垫9、试条反应终点指示标签13。分析膜8具有检测带6和质控带7。卡盒3的上盒面在对应于试条样品垫4位置处开有加样孔10。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13位置处开有观察窗14。卡盒3上安装有一存贮介质12。
所述试条2的标记垫5包被有单一标记物标记的某一目标被检物检测相关的单一特异分子，或：包被有不同标记物对应标记的各目标被检物检测相关的特异分子的混合物。
所述试条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。
所述试条2的质控带7包被有质控物。所述质控物包括二抗。
所述试条反应终点指示标签13包括但不限于变色范围为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13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。
所述卡盒3上的存贮介质12包括但不限于RFID标签、IC芯片、磁码、或条码等。存贮介质12储存有同批次试条2定量样品浓度用的被检物标准曲线或系数参数、试条质控带信号强度参考监控值、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。
所述存贮介质12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A检测带/A质控带之间的对应关系曲线；或，被检物标准品系列浓度与A检测带/(A检测带+A质控带)之间的对应关系曲线。其中，A检测带为被检物标准品系列浓度测得的检测带信号强度，A质控带为被检物标准品系列浓度测得的质控带信号强度。
所述试条2的标记垫5为玻璃纤维膜；所述试条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。
所述试条2为任何试条，其包括但不限于量子点标记试条、胶体金标记试条、胶体硒标记试条、上转换磷光物标记试条、纳米稀土荧光配合物标记试条、纳米磁性颗粒标记试条、时间分辨层析试条、化学发光试条。
所述试条卡用于样品检测时，液体样品被施加到试条卡的加样孔10中，待其内试条2的试条反应终点指示标签13指示样品在试条2上完成反应后，由具有信号检测功能的仪器(如读条仪、荧光检测仪、磁信号检测仪等)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12同时读取来的被检物标准曲线或系数参数而定量获得样品单组分或多组分浓度；或，根据所述试条卡的试条检测带6和质控带7的显示情况而定性或半定量检测样品组分。
所述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。
需要指出的是，本发明所述试条卡还可以有其他改进，如存储有被检物标准曲线等检测用信息的存贮介质12除了安装在试条卡的卡盒3上外，还可直接安装在试条卡内试条2上；基于本发明相同原理，卡盒3内的试条还可扩展替换为生物芯片(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。

Claims (18)

  1. 一种试条卡，包括卡盒(3)和其内的试条(2)，试条(2)包括顺次搭接固定在底衬(1)上的样品垫(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样品垫(4)位置处开有加样孔(10)，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：所述卡盒(3)上还安装有一存贮介质(12)。
  2. 根据权利要求1所述的试条卡，其特征在于：
    所述试条(2)的标记垫(5)包被有单一标记物标记的某一目标被检物检测相关的单一特异分子，或：包被有不同标记物对应标记的各目标被检物检测相关的特异分子的混合物；
    所述试条(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；
    所述试条(2)的质控带(7)包被有包括二抗的质控物。
  3. 根据权利要求1所述的试条卡，其特征在于：所述卡盒(3)上的存贮介质(12)包括RFID标签、IC芯片、磁码、或条码。
  4. 根据权利要求1所述的试条卡，其特征在于：所述存贮介质(12)储存有同批次试条(2)定量样品浓度用的被检物标准曲线或系数参数、试条质控带信号强度参考监控值、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。
  5. 根据权利要求4所述的试条卡，其特征在于：所述存贮介质(12)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A检测带/A质控带之间的对应关系曲线；或，被检物标准品系列浓度与A检测带/(A检测带+A质控带)之间的对应关系曲线；其中，A检测 带为被检物标准品系列浓度测得的检测带信号强度，A质控带为被检物标准品系列浓度测得的质控带信号强度。
  6. 根据权利要求1所述的试条卡，其特征在于：
    所述试条(2)的标记垫(5)为玻璃纤维膜，所述试条(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；
    所述试条(2)的底衬(1)为聚脂或塑料板；
    所述卡盒(3)为聚脂、塑料、或硬性纸质材料做成。
  7. 根据权利要求1所述的试条卡，其特征在于：其中所述试条(2)为任何试条，其包括量子点标记试条、胶体金标记试条、胶体硒标记试条、上转换磷光物标记试条、纳米稀土荧光配合物标记试条、纳米磁性颗粒标记试条、时间分辨层析试条、化学发光试条。
  8. 根据权利要求1所述的试条卡，其特征在于：
    样品检测时，具有信号检测功能的仪器采集试条卡内试条(2)的检测带(6)和质控带(7)特征信号并结合该仪器从存贮介质(12)同时读取的被检物标准曲线或系数参数而定量获得样品单组分或多组分浓度；或，
    样品检测时，根据所述试条卡的试条检测带(6)和质控带(7)的显示情况而定性或半定量检测样品组分。
  9. 一种如权利要求1所述的试条卡，其特征在于：其中所述试条(2)的吸水垫(9)之后还搭接有一试条反应终点指示标签(13)；其卡盒(3)的该试条反应终点指示标签(13)相应处开有观察窗(14)。
  10. 根据权利要求9所述的试条卡，其特征在于，所述试条反应终点指示标签(13)包括变色范围为5-9的pH试纸。
  11. 根据权利要求9所述的试条卡，其特征在于：
    所述试条(2)的标记垫(5)包被有单一标记物标记的某一目标被检物检测相关的单一特异分子，或：包被有不同标记物对应标记的各目标被检物检测相关的特异分子的混合物；
    所述试条(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；
    所述试条(2)的质控带(7)包被有包括二抗的质控物。
  12. 根据权利要求9所述的试条卡，其特征在于：所述卡盒(3)上的存贮介质(12)包括RFID标签、IC芯片、磁码、或条码。
  13. 根据权利要求9所述的试条卡，其特征在于：所述存贮介质(12)储存有同批次试条(2)定量样品浓度用的被检物标准曲线或系数参数、试条质控带信号强度参考监控值、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。
  14. 根据权利要求13所述的试条卡，其特征在于：所述存贮介质(12)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A检测带/A质控带之间的对应关系曲线；或，被检物标准品系列浓度与A检测带/(A检测带+A质控带)之间的对应关系曲线；其中，A检 测带为被检物标准品系列浓度测得的检测带信号强度，A质控带为被检物标准品系列浓度测得的质控带信号强度。
  15. 根据权利要求9所述的试条卡，其特征在于：
    所述试条(2)的标记垫(5)为玻璃纤维膜，所述试条(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；
    所述试条(2)的底衬(1)为聚脂或塑料板；
    所述卡盒(3)为聚脂、塑料、或硬性纸质材料做成。
  16. 根据权利要求9所述的试条卡，其特征在于：其中所述试条(2)为任何试条，其包括量子点标记试条、胶体金标记试条、胶体硒标记试条、上转换磷光物标记试条、纳米稀土荧光配合物标记试条、纳米磁性颗粒标记试条、时间分辨层析试条、化学发光试条。
  17. 根据权利要求9所述的试条卡，其特征在于：
    样品检测时，具有信号检测功能的仪器采集试条卡内试条(2)的检测带(6)和质控带 (7)特征信号并结合该仪器从存贮介质(12)同时读取的被检物标准曲线或系数参数而定量获得样品单组分或多组分浓度；或，
    样品检测时，根据所述试条卡的试条检测带(6)和质控带(7)的显示情况而定性或半定量检测样品组分。
  18. 一种如权利要求1或9所述的试条卡，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。
PCT/CN2014/089637 2013-11-13 2014-10-28 一种试条卡 WO2015070703A1 (zh)

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