CN203759015U - Test strip card - Google Patents

Test strip card Download PDF

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Publication number
CN203759015U
CN203759015U CN 201320716427 CN201320716427U CN203759015U CN 203759015 U CN203759015 U CN 203759015U CN 201320716427 CN201320716427 CN 201320716427 CN 201320716427 U CN201320716427 U CN 201320716427U CN 203759015 U CN203759015 U CN 203759015U
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China
Prior art keywords
test strip
strip
sample
cartridge
labeled
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CN 201320716427
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Chinese (zh)
Inventor
马义才
顾敏
马灵
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成都领御生物技术有限公司
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Publication of CN203759015U publication Critical patent/CN203759015U/en

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Abstract

The utility model belongs to the field of in vitro diagnosis and in particular relates to a test strip card provided with a storage medium (12) for storing information for detection, such as standard curves or coefficient parameters and the like of detected objects. The test strip card comprises a card case (3) and a test strip (2) in the card case, wherein the storage medium (12) is installed on the card case (3). When samples are detected, the test strip card is characterized in that an instrument with the signal detection function is used for collecting the characteristic signals of detection bands (6) and a quality control band (7) of the test strip (2) in the test strip card and standard curves or coefficient parameters of detected objects, which are simultaneously read by the used instrument from the storage medium (12), are combined to obtain single-component or multicomponent concentrations of the samples. The test strip card has the characteristics of simplicity and quickness, high sensitivity, objective results, flexibility in use and the like when being used for detecting samples.

Description

一种试条卡 One kind of test strip card

技术领域 FIELD

[0001] 本实用新型属于体外诊断领域,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。 [0001] The present invention belongs to the field of in vitro diagnostics, in particular, to a storage medium storage apparatus 12 is a standard analyte curve parameters or coefficients detection information along with the instrument having a signal detection function can be quickly detected with its own set of one single sample or multi-component test strip card.

背景技术 Background technique

[0002] 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。 [0002] In colloidal gold as the main representative test strip immunochromatographic test strip technology it is now widely used in various aspects of immunoassays. 该技术简单快速,几分钟就能获得结果。 The technique is simple and fast, a few minutes to get results. 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。 The downside is that: (1) qualitative detection of only a sample, quantitative detection of the sample is difficult to achieve, more difficult to achieve the quantitative analysis of multi-component samples. (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。 (2) For a very low content of certain antigen or antibody samples, the result is difficult to judge with the naked eye, the detection sensitivity is low.

[0003] 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。 [0003] The subject was a standard curve of standard analyte concentration is quantified, it is the main sample concentration quantitative detection. 标准曲线制作技术性强,过程繁杂,离不开专业技术人员。 Standard curve highly technical, complicated process, is inseparable from the professional and technical personnel. 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。 Recent developments in the information storage medium of the art, such as an RFID tag (also known as radio frequency identification tag), IC chips, magnetic code, bar code, identification information for access has been widely used in computers, communications, electronics, business, transport control field management. 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。 RFID tags, small size and large information storage capacity, without human intervention recognition, is the ideal means of identifying information access, but it is rarely used in biomedical testing field.

[0004]为克服现有技术的不足,本实用新型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。 [0004] To overcome the deficiencies of the prior art, the present invention provides a storage medium with its own storage apparatus 12 is a standard analyte curve parameters or coefficients detection information (Needless remanufacturing operation when the person is the subject test sample was the standard curve), in conjunction with the instrument having a signal detection function can be implemented quickly monocomponent or multicomponent quantitative samples (qualitative / semiquantitative) detection test strip card. 本实用新型用于样品检测,具有简便快速、灵敏度高、结果客观等特点。 The present invention for detecting a sample, having a simple, rapid, sensitive, and objective results and so on.

实用新型内容 SUMMARY

[0005] 本实用新型技术方案如下: [0005] The technical solution of the present invention are as follows:

[0006] 本实用新型所述试条卡包括卡盒3和其内的试条2。 [0006] The test strip of the present invention comprises a test strip card 3 and the cartridge 2 therein. 试条2包括顺次搭接固定在底衬I上的样品垫4、标记垫5、分析膜8、吸水垫9。 2 comprises sequentially overlapping strip sample is fixed on the backsheet 4 I pad, label pad 5, the analysis membrane 8, an absorbent pad 9. 分析膜8具有检测带6和质控带7。 Analysis film 8 having a detection zone 6 and control line 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。 The panels 3 in the cartridge corresponding to the test strip at the sample pad 4 is opened position sample hole 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。 The panels 3 in the cartridge corresponding to the position of the film strip 8 at analyzing the detection window 11 is opened. 卡盒3上安装有一张存贮有试条检测样品用信息的存贮介质12。 The cartridge 3 is mounted on a test strip with a test sample storage medium 12 with the stored information.

[0007] 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抗原(或抗体)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抗原(或抗体)分子的混合物。 [0007] 2 of the test strip marking pad 5 is coated with a single target certain markers labeled detection subject related monospecific antigen (or antibody) molecules, or: coated with different labels corresponding to each tag the target is (or antibody) was associated with specific antigen molecule analyte detection.

[0008] 所述试条2的检测带6可以为一条,也可以为多条。 [0008] The detection of the test strip 2 may be a strip 6, may be a plurality. 检测带6包被有某一目标被检物检测相关的特异抗体(或抗原)分子,或:包被有各目标被检物检测相关的特异抗体(或抗原)分子的混合物。 Detection zone 6 is coated with an antibody specific for a target by the associated detection subject (or antigen) molecules, or: a mixture of specific antibodies coated with each of the target detection object is associated (or antigen) molecules.

[0009] 所述试条2的质控带7包被有质控物。 [0009] The test strip 2 is coated with a control line 7 quality control substance. 所述质控物包括二抗。 The quality control material comprises a secondary antibody.

[0010] 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。 [0010] 3 stored on the media cartridge 12 including, but not limited to RFID tags, IC chips, magnetic code, bar code, or the like. 存贮介质12存贮的试条检测样品用信息包括同批次试条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。 Strip test sample storage medium 12 stores the information for the detected object includes a standard curve parameters or coefficients of the same batch test strip 2 with sample concentration quantitatively, test strip quality control monitor signal strength reference value band, test strip lot number, test strip expiration date, password storage medium, the reference value of the clinical index, the strip manufacturer information, and read into the measured object identity information, user information detected, sample name, sample number, date of detection, detection result information.

[0011] 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 IA 之间的对应关系曲线;或,被检物标准品系列浓度与乂../ CA 之间的对应关系曲线。 [0011] The storage medium 12 stores a calibration curve of the test object to choose a variety of forms, including but not limited to, the following curve: a curve corresponding relationship between the analyte concentration series of the standard A IA; or is a graph of a correspondence relationship between analyte concentration and the standards series qe ../ CA. 其中,乂..为被检物标准品系列浓度测得的检测带信号强度为被检物标准品系列浓度测得的质控带信号强度。 Wherein the test object is qe .. standard series measured concentration with a detection signal intensity measured by the standard analyte concentration series of control line signal intensity.

[0012] 本实用新型所述试条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。 [0012] The present invention 9 of the test strip after the absorbent pad 2 may also overlap a test strip label 13 indicating the end of the reaction. 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。 Accordingly, the test strip cartridge which 3 indicates the end of reaction the corresponding tab 13 at the viewing window 14 is opened. 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。 The test strip reaction end position indication label 13 including but not limited to the color range of 5-9 pH paper.

[0013] 本实用新型所述试条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;所述试条2的底衬I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。 [0013] The test strip of the present invention, numeral 2 a glass fiber membrane pad 5; analytical membrane of the test strip 2 to a nitrocellulose membrane 8; 2 backsheet of the test strip of polyester or plastic plate I is ; the cartridge 3 is polyester, plastic, rigid paper material, or made of other materials.

[0014] 本实用新型所述试条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。 [0014] The test strip of the present invention, any test strip 2, including but not limited to the quantum dot-marked test strip, test strip labeled with colloidal gold, colloidal selenium labeled test strip, the test strip labeled phosphorescence conversion, nano-rare earth phosphors complex marked test strip, test strip nanomagnetic particle labels, time resolved chromatography test strip, test strip chemiluminescence.

[0015] 本实用新型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。 [0015] The present invention said test strip card after completion of the test strip is a test strip reaction sample was collected by the instrument (e.g., reading of, fluorescence detector, a magnetic signal detector, etc.) having a signal detection function which bars second detection zone and the control zone 6 and 7 in combination characterized in that the signal from the instrument to read the storage medium 12 while the subject was a standard curve parameters or coefficients obtained quantitatively monocomponent or multicomponent sample concentration; or, according to the test strip card of the test strip the detection zone 6 and control line 7 of the display case of qualitative or semi-quantitative detection of sample components.

[0016] 本实用新型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O [0016] The test strip of the present invention, the card may be a sample to be tested from a clinical or non-clinical blood, body fluid, urine, saliva, genital secretions, or other liquid or viscous sample sample, wherein a clinical sample sample, non-clinical samples, including infectious diseases, hormones, cardiovascular disease, cancer, cancer, diabetes, autoimmune diseases, etc., including food testing, environmental testing, pesticide residues detection, detection of biological contamination, biological agent detection, beast medical testing, drug testing, including sample O

[0017] 本实用新型具有如下有益效果: [0017] The present invention has the following advantages:

[0018] (I)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)。 [0018] (I) may be rapid quantitative detection of sample components (including qualitative or semi-quantitative detection of sample components). 本实用新型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。 The present invention is mounted on the test strip card storage medium 12, storage medium 12 which stores the calibration curve information for analyte detection parameters or coefficients. 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。 After completion of the test sample on the chromatography strip in the reaction, the test strip within the test strip card capture device having a signal detection function of the detection 2 and the control line of belt 6 and 7 in combination characterized in that the signal from the storage medium 12 while the instrument the analyte a standard curve to read the parameters or coefficients to quickly (within minutes) the sample component concentrations obtained quantitatively.

[0019] (2)本实用新型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。 [0019] (2) the test strip within the test strip of the present invention when the card 2 quantum dot marks can simultaneously achieve rapid and accurate quantitative detection of the multicomponent sample. 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。 A quantum dot (Quantum Dots, referred QDs) is a semiconductor nanocrystal having superior photochemical stability and spectral characteristics of development in the 1990s, it has a high fluorescence emission efficiency, wide spectral range of excitation, narrow emission spectrum range, fluorescence long-life, large Stokes displacement, particle size similar to a biomolecule, a rear surface energy modified multifunctional characteristics. 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。 Different size, type and structure of the quantum dot can produce different characteristic fluorescence peak wavelengths continuous spectrum, and the peak wavelength of the fluorescence spectrum characteristic of quantum dots do not overlap resulting mixture. 采用不同量子点分别标记被检物相应抗原/抗体反应分子,将其混合物包被在本实用新型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。 Different markers are quantum dots corresponding to the analyte antigen / antibody molecule reaction, the mixtures were coated on the test strip in the test strip of the present invention with a test sample card reaction, by measuring the specific fluorescence signal strip, several can quickly and accurately quantify the concentration of a multicomponent sample within minutes. 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。 Whereas the prior art test strip can only be a qualitative test sample, quantitative detection of the sample can not be achieved, but can not achieve the quantitative detection of multi-component samples.

[0020] (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。 The [0020] (3) the test strip materials and reagents card does not involve inactivation activity, long-term storage at room temperature.

附图说明 BRIEF DESCRIPTION

[0021] 图1:本实用新型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) [0021] FIG 1: the present invention a preferred embodiment of a test strip card configuration diagram of a plan view (which shows the use of a detection line bars)

[0022] 图2:本实用新型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) [0022] FIG. 2: the present invention the preferred embodiment the test strip card test strip within the cartridge side view of a configuration diagram (shown using a test strip detection line)

[0023]图3:本实用新型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) [0023] Figure 3: the present invention a preferred embodiment of a test strip card configuration diagram of a plan view (which shows the bars using a plurality of detection lines)

[0024] 图4:本实用新型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) [0024] FIG. 4: the present invention a preferred embodiment of the test strip card test strip within the cartridge side view of a configuration diagram (shown bars using a plurality of detection lines)

[0025] 图5:本实用新型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) [0025] Figure 5: a plan view of another configuration of the present preferred embodiment of the invention the test strip card (shown using a test strip within the test line)

[0026] 图6:本实用新型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) [0026] FIG. 6: the test strip within the cartridge to another preferred embodiment of the present invention, the card side structural view of the test strip (shown using a test strip detection line)

[0027]图7:本实用新型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) [0027] Figure 7: the present invention the test strip card plan view showing another preferred embodiment (shown within bars using a plurality of detection lines)

[0028] 图8:本实用新型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) [0028] FIG. 8: the test strip within the cartridge further preferred embodiment of the present invention a side view of the test strip card configuration diagram (shown bars using a plurality of detection lines)

[0029] 序号表示如下: [0029] Reference is represented as follows:

[0030] 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、 [0030] 1, backsheet, 2, test strip, 3, the cartridge 4, a sample pad, 5, marking pad 6, the detection zone, 7, the control line, 8, analysis membrane, 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 Absorbent pad 10, sample hole 11, the detection window 12, the storage medium 13, the test strip reaction end position indication label 14, the viewing window

具体实施方式 Detailed ways

[0031] 下面实施例及其附图仅是为了进一步说明本实用新型,本领域人员不应以此限制本实用新型的保护范围。 [0031] The following examples and embodiments are merely to further illustrate the present invention, those skilled in the art should not be used to limit the scope of protection of the present invention the drawings.

[0032] 实施例一 [0032] Example a

[0033] 图1-4说明实施例一。 [0033] FIGS 1-4 illustrate an embodiment. 实施例一为本实用新型所述试条卡优选方案之一。 One embodiment of the invention, a preferred embodiment of a test strip card present.

[0034] 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。 In [0034] Figures 1-4, the preferred embodiment of the test strip cartridge comprises a card 3 and strip 2 inside thereof. 所述试条2包括顺次搭接固定在底衬I上的样品垫4、标记垫5、分析膜8、吸水垫9。 The strip 2 comprises a sample holder sequentially overlapped on the underlay I pad 4, 5 marking pad, analytical membrane 8, an absorbent pad 9. 分析膜8具有检测带6和质控带7。 Analysis film 8 having a detection zone 6 and control line 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。 The panels 3 in the cartridge corresponding to the test strip at the sample pad 4 is opened position sample hole 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。 The panels 3 in the cartridge corresponding to the position of the film strip 8 at analyzing the detection window 11 is opened. 卡盒3上安装有一张存贮有试条检测样品用信息的存贮介质12。 The cartridge 3 is mounted on a test strip with a test sample storage medium 12 with the stored information.

[0035] 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抗原(或抗体)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抗原(或抗体)分子的混合物。 [0035] 2 of the test strip marking pad 5 is coated with a single target certain markers labeled detection subject related monospecific antigen (or antibody) molecules, or: coated with different labels corresponding to each tag the target is (or antibody) was associated with specific antigen molecule analyte detection. [0036] 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)。 [0036] The detection of the test strip 2 may be a tape 6 (FIG. 1 and FIG. 2), may be a plurality of (in FIG. 3 and FIG. 4). 检测带6包被有某一目标被检物检测相关的特异抗体(或抗原)分子,或:包被有各目标被检物检测相关的特异抗体(或抗原)分子的混合物。 Detection zone 6 is coated with an antibody specific for a target by the associated detection subject (or antigen) molecules, or: a mixture of specific antibodies coated with each of the target detection object is associated (or antigen) molecules.

[0037] 所述试条2的质控带7包被有质控物。 [0037] The test strip 2 is coated with a control line 7 quality control substance. 所述质控物包括二抗。 The quality control material comprises a secondary antibody.

[0038] 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。 [0038] 3 stored on the media cartridge 12 including, but not limited to RFID tags, IC chips, magnetic code, bar code, or the like. 存贮介质12存贮的试条检测样品用信息包括同批次试条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。 Strip test sample storage medium 12 stores the information for the detected object includes a standard curve parameters or coefficients of the same batch test strip 2 with sample concentration quantitatively, test strip quality control monitor signal strength reference value band, test strip lot number, test strip expiration date, password storage medium, the reference value of the clinical index, the strip manufacturer information, and read into the measured object identity information, user information detected, sample name, sample number, date of detection, detection result information.

[0039] 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 IA 之间的对应关系曲线;或,被检物标准品系列浓度与乂../ CA 之间的对应关系曲线。 [0039] The storage medium 12 stores a calibration curve of the test object to choose a variety of forms, including but not limited to, the following curve: a curve corresponding relationship between the analyte concentration series of the standard A IA; or is a graph of a correspondence relationship between analyte concentration and the standards series qe ../ CA. 其中,乂..为被检物标准品系列浓度测得的检测带信号强度为被检物标准品系列浓度测得的质控带信号强度。 Wherein the test object is qe .. standard series measured concentration with a detection signal intensity measured by the standard analyte concentration series of control line signal intensity.

[0040] 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;所述试条2的底衬I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。 [0040] The pad test strip labeled 5 2 glass fiber membrane; analytical membrane of the test strip is 2 to 8 nitrocellulose membrane; 2 the underlay strip or plastic plate I is polyester; the 3 cartridge polyester, plastic, rigid paper material, or made of other materials.

[0041] 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、纳米稀土突光配合物标记试条、纳米磁性颗粒标记试条、时间分辨层析试条、化学发光试条。 [0041] The test strip of any test strip 2, including but not limited to the quantum dot-marked test strip, test strip labeled with colloidal gold, colloidal selenium labeled test strip, the test strip labeled phosphorescence conversion, nano-rare earth complexes projection light marked test strip, test strip nanomagnetic particle labels, time resolved chromatography test strip, test strip chemiluminescence.

[0042] 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。 [0042] The test strip card when detecting a sample, a liquid sample is applied to the test strip card loading aperture 10, until the strip 2 after the completion of the reaction, the instrument has a signal detection function (e.g., reading of , fluorescence detector, a magnetic signal detector, etc.) which is collected with a strip 6 and a second detection signal the control line 7 in conjunction with the features of the instrument 12 to be read simultaneously analyte test strip card from a standard curve storage medium quantitative parameters or coefficients to obtain a sample single or multi-component concentration; or, according to the test strip card 6 test strip the detection zone and the control zone of the display case 7 qualitative or semi-quantitative detection of the sample components.

[0043] 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。 [0043] The test strip card sample to be tested may be derived from clinical or non-clinical blood, body fluid, urine, saliva, genital secretions, or other liquid or viscous sample sample, wherein the clinical sample comprises Infectious Diseases sample hormones, cardiovascular disease, cancer, cancer, diabetes, autoimmune disease, etc., and non-clinical samples include food testing, environmental testing, pesticide residues detected, the detection of biological contamination, the biological agent detection, veterinary testing, drug testing, including a sample.

[0044] 实施例二 [0044] Second Embodiment

[0045] 图5-8说明实施例二。 [0045] Figures 5-8 illustrate the second embodiment. 实施例二为本实用新型所述试条卡的另一优选方案。 Another preferred embodiment of the invention of the test strip card according to the second present.

[0046] 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。 In [0046] FIG. 5-8, the preferred embodiment the test strip comprises a test strip card 3 and the cartridge 2 therein. 所述试条2包括顺次搭接固定在底衬I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。 The strip 2 comprises a sample holder sequentially overlapped on the underlay I pad 4, 5 marking pad, analytical membrane 8, 9 absorbent pad, test strip label 13 indicating the end of the reaction. 分析膜8具有检测带6和质控带7。 Analysis film 8 having a detection zone 6 and control line 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。 The panels 3 in the cartridge corresponding to the test strip at the sample pad 4 is opened position sample hole 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。 The panels 3 in the cartridge corresponding to the position of the film strip 8 at analyzing the detection window 11 is opened. 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。 The panels at the cartridge 3 corresponds to the test strip reaction end position of the label 13 indicating the observation window 14 is opened. 卡盒3上安装有一张存贮有试条检测样品用信息的存贮介质12。 The cartridge 3 is mounted on a test strip with a test sample storage medium 12 with the stored information.

[0047] 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抗原(或抗体)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抗原(或抗体)分子的混合物。 [0047] 2 of the test strip marking pad 5 is coated with a single target certain markers labeled detection subject related monospecific antigen (or antibody) molecules, or: coated with different labels corresponding to each tag the target is (or antibody) was associated with specific antigen molecule analyte detection. [0048] 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)。 [0048] The detection of the test strip 2 may be a tape 6 (FIG. 5 and FIG. 6), or may be a plurality of (in FIG. 7 and FIG. 8). 检测带6包被有某一目标被检物检测相关的特异抗体(或抗原)分子,或:包被有各目标被检物检测相关的特异抗体(或抗原)分子的混合物。 Detection zone 6 is coated with an antibody specific for a target by the associated detection subject (or antigen) molecules, or: a mixture of specific antibodies coated with each of the target detection object is associated (or antigen) molecules.

[0049] 所述试条2的质控带7包被有质控物。 [0049] The test strip 2 is coated with a control line 7 quality control substance. 所述质控物包括二抗。 The quality control material comprises a secondary antibody.

[0050] 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。 [0050] The test strip reaction end position indication label 13 including but not limited to the color range of 5-9 pH paper. 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。 The sample is detected, the test strip on the test strip reaction end tab 13 can be indicative of a color test strip according to the pH conditions of the reaction, suggesting whether the test strip has been sufficiently reactant bleeding through the detection zone 6 and control line 7, suggesting again Article whether sufficient reaction, the detection result is valid.

[0051] 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。 [0051] 3 stored on the media cartridge 12 including, but not limited to RFID tags, IC chips, magnetic code, bar code, or the like. 存贮介质12存贮的试条检测样品用信息包括同批次试条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。 Strip test sample storage medium 12 stores the information for the detected object includes a standard curve parameters or coefficients of the same batch test strip 2 with sample concentration quantitatively, test strip quality control monitor signal strength reference value band, test strip lot number, test strip expiration date, password storage medium, the reference value of the clinical index, the strip manufacturer information, and read into the measured object identity information, user information detected, sample name, sample number, date of detection, detection result information.

[0052] 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 IA 之间的对应关系曲线;或,被检物标准品系列浓度与乂../ CA 之间的对应关系曲线。 [0052] The storage medium 12 stores a calibration curve of the test object to choose a variety of forms, including but not limited to, the following curve: a curve corresponding relationship between the analyte concentration series of the standard A IA; or is a graph of a correspondence relationship between analyte concentration and the standards series qe ../ CA. 其中,乂..为被检物标准品系列浓度测得的检测带信号强度为被检物标准品系列浓度测得的质控带信号强度。 Wherein the test object is qe .. standard series measured concentration with a detection signal intensity measured by the standard analyte concentration series of control line signal intensity.

[0053] 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;所述试条2的底衬I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。 [0053] The pad test strip labeled 5 2 glass fiber membrane; analytical membrane of the test strip is 2 to 8 nitrocellulose membrane; 2 the underlay strip or plastic plate I is polyester; the 3 cartridge polyester, plastic, rigid paper material, or made of other materials.

[0054] 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、纳米稀土突光配合物标记试条、纳米磁性颗粒标记试条、时间分辨层析试条、化学发光试条。 [0054] The test strip of any test strip 2, including but not limited to the quantum dot-marked test strip, test strip labeled with colloidal gold, colloidal selenium labeled test strip, the test strip labeled phosphorescence conversion, nano-rare earth complexes projection light marked test strip, test strip nanomagnetic particle labels, time resolved chromatography test strip, test strip chemiluminescence.

[0055] 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。 [0055] The test strip card when detecting a sample, a liquid sample is applied to the loading wells 10 of the test strip card, until the test strip within the test strip in the test strip 2, the end of the reaction indicated on the label 13 indicates Sample 2 after completion of the reaction characteristics of the signal, the test strip by the instrument (e.g., reading of, fluorescence detector, a magnetic signal detector, etc.) with the signal detection acquisition function and the control detection zone 6 and 7 in conjunction with the instrument from the test strip card storage medium 12 is read simultaneously to the analyte a standard curve parameters or coefficients obtained quantitatively monocomponent or multicomponent sample concentration; or, according to the test strip with a test strip card detection and control line 7 6 display case qualitative or semi-quantitative detection of sample components.

[0056] 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。 [0056] The test strip card sample to be tested may be derived from clinical or non-clinical blood, body fluid, urine, saliva, genital secretions, or other liquid or viscous sample sample, wherein the clinical sample comprises Infectious Diseases sample hormones, cardiovascular disease, cancer, cancer, diabetes, autoimmune disease, etc., and non-clinical samples include food testing, environmental testing, pesticide residues detected, the detection of biological contamination, the biological agent detection, veterinary testing, drug testing, including a sample.

[0057] 需要指出的是,本实用新型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;基于本实用新型相同原理,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。 [0057] It should be noted that the present invention, the test strip cards can also be other modifications, such as storing a test object 3 to be detected with a standard curve of the information storage medium 12 in addition to the test strip cartridge is mounted on the card in addition, the test can also be mounted directly in the test strip card strip 2; based on the same principles of the new utility, the test strip within the cartridge 3 can also be extended to replace the biochip (including antigen-antibody chip, a protein chip, a nucleic acid chips, microchips fluidic chip) and the like. 因此,凡是对本实用新型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,均落在本实用新型权利要求的保护范围中。 Therefore, all equivalent technical solutions by any other equivalent or alternative conversion of the present invention is formed of said test strip card, all fall within the scope of the present disclosure claims.

Claims (9)

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(I)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)上还安装有一张存贮有试条检测样品用信息的存贮介质(12)。 A test strip card, comprising a cartridge (3) therein and a strip (2), the strip (2) comprises a sequentially overlapping a fixed sample pad (4) on the underlay (I), a mark pad (5), analytical membrane (8), an absorbent pad (9), analytical membrane (8) having a detection zone (6) and a control line (7), the detection zone (6) is one or more, the cartridge ( 3) the panels corresponding to the test strip sample pad (4) at a position apart with a loading aperture (10), the panels cartridge (3) in the corresponding strip analytical membrane (8) at a position opened the detection window (11), characterized in that: the cartridge (3) there is also mounted a memory strip with the test sample information storage medium (12).
2.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。 The test strip card according to claim 1, wherein: said storage medium on the cartridge (3) (12) comprises an RFID tag, IC chips, magnetic code or barcode.
3.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,所述试条(2)的底衬(I)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。 The test strip card according to claim 1, wherein: said strip (2) of the marking pad (5) is a glass fiber membrane, the strip (2) Analysis of the film (8) nitric acid cellulose film, said strip (2) of the underlay (I) is a polyester or a plastic sheet, said cartridge (3) is a polyester, plastic or paper material made rigid.
4.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。 The test strip card according to claim 1, wherein: wherein said bars (2) quantum dot-marked test strip, test strip labeled with colloidal gold, colloidal selenium labeled test strip, the sample labeled phosphorescence conversion Article nano fluorescent complexes of rare earth labeled test strip, test strip labeled magnetic nanoparticles, the time resolution chromatography test strip, test strip chemiluminescence.
5.一种如权利要求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)。 5. A test strip card according to claim 1, wherein: wherein, after the test strip (2) an absorbent pad (9) further has a lap test strip reaction end position indication label (13); snap box (3) the test strip reaction end position indication label (13) is opened at a respective observation window (14).
6.根据权利要求5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。 6. A test strip card according to claim 5, characterized in that, the test strip reaction end position indication label (13) comprises a color in the range of 5-9 pH paper.
7.根据权利要求5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。 7. The test strip card according to claim 5, characterized in that: said storage medium on the cartridge (3) (12) comprises an RFID tag, IC chips, magnetic code or barcode.
8.根据权利要求5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,所述试条(2)的底衬(I)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。 8. The test strip card according to claim 5, wherein: analytical membrane (8) of the bars (2) a marking pad (5) is a glass fiber membrane, the strip (2) of nitrate cellulose film, said strip (2) of the underlay (I) is a polyester or a plastic sheet, said cartridge (3) is a polyester, plastic or paper material made rigid.
9.根据权利要求5所述的试条卡,其特征在于:其中所述试条(2)为量子点标记试条、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。 9. The test strip card according to claim 5, characterized in that: wherein said bars (2) quantum dot-marked test strip, test strip labeled with colloidal gold, colloidal selenium labeled test strip, the sample labeled phosphorescence conversion Article nano fluorescent complexes of rare earth labeled test strip, test strip labeled magnetic nanoparticles, the time resolution chromatography test strip, test strip chemiluminescence.
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* Cited by examiner, † Cited by third party
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WO2015070703A1 (en) * 2013-11-13 2015-05-21 成都领御生物技术有限公司 Test strip card
WO2015070749A1 (en) * 2013-11-16 2015-05-21 成都领御生物技术有限公司 Test strip card
WO2015070700A1 (en) * 2013-11-12 2015-05-21 成都领御生物技术有限公司 Quantum dot-labeled test strip card
WO2015070704A1 (en) * 2013-11-13 2015-05-21 成都领御生物技术有限公司 Test bar card
WO2015070699A1 (en) * 2013-11-12 2015-05-21 成都领御生物技术有限公司 Quantum dot-labeled test strip card
WO2016094761A3 (en) * 2014-12-11 2016-08-25 Critical Care Diagnostics, Inc. Test apparatus and methods for st2 cardiac biomarker
US10079073B2 (en) 2014-12-11 2018-09-18 Critical Care Diagnostics, Inc. Test apparatus and methods for ST2 cardiac biomarker
US10324089B2 (en) 2014-12-11 2019-06-18 Critical Care Diagnostics, Inc. Test apparatus and methods for ST2 cardiac biomarker

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015070700A1 (en) * 2013-11-12 2015-05-21 成都领御生物技术有限公司 Quantum dot-labeled test strip card
WO2015070699A1 (en) * 2013-11-12 2015-05-21 成都领御生物技术有限公司 Quantum dot-labeled test strip card
WO2015070703A1 (en) * 2013-11-13 2015-05-21 成都领御生物技术有限公司 Test strip card
WO2015070704A1 (en) * 2013-11-13 2015-05-21 成都领御生物技术有限公司 Test bar card
WO2015070749A1 (en) * 2013-11-16 2015-05-21 成都领御生物技术有限公司 Test strip card
WO2016094761A3 (en) * 2014-12-11 2016-08-25 Critical Care Diagnostics, Inc. Test apparatus and methods for st2 cardiac biomarker
CN107209175A (en) * 2014-12-11 2017-09-26 重症监护诊断股份有限公司 Test apparatus and methods for ST2 cardiac biomarker
US10079073B2 (en) 2014-12-11 2018-09-18 Critical Care Diagnostics, Inc. Test apparatus and methods for ST2 cardiac biomarker
US10324089B2 (en) 2014-12-11 2019-06-18 Critical Care Diagnostics, Inc. Test apparatus and methods for ST2 cardiac biomarker
US10325682B2 (en) 2014-12-11 2019-06-18 Critical Care Diagnostics, Inc. Test apparatus and methods for ST2 cardiac biomarker

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