CN107957493A - 艾滋病(尿液、唾液)和毒品多项快速检测试剂盒 - Google Patents

艾滋病(尿液、唾液)和毒品多项快速检测试剂盒 Download PDF

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CN107957493A
CN107957493A CN201610901828.3A CN201610901828A CN107957493A CN 107957493 A CN107957493 A CN 107957493A CN 201610901828 A CN201610901828 A CN 201610901828A CN 107957493 A CN107957493 A CN 107957493A
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陈洁
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Chengdu Jing Jing Biological Technology Co Ltd
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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/569Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
    • G01N33/56983Viruses
    • G01N33/56988HIV or HTLV
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/558Immunoassay; Biospecific binding assay; Materials therefor using diffusion or migration of antigen or antibody
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
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    • G01N2333/15Retroviridae, e.g. bovine leukaemia virus, feline leukaemia virus, feline leukaemia virus, human T-cell leukaemia-lymphoma virus
    • G01N2333/155Lentiviridae, e.g. visna-maedi virus, equine infectious virus, FIV, SIV
    • G01N2333/16HIV-1, HIV-2
    • G01N2333/161HIV-1, HIV-2 gag-pol, e.g. p55, p24/25, p17/18, p.7, p6, p66/68, p51/52, p31/34, p32, p40
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/005Assays involving biological materials from specific organisms or of a specific nature from viruses
    • G01N2333/08RNA viruses
    • G01N2333/15Retroviridae, e.g. bovine leukaemia virus, feline leukaemia virus, feline leukaemia virus, human T-cell leukaemia-lymphoma virus
    • G01N2333/155Lentiviridae, e.g. visna-maedi virus, equine infectious virus, FIV, SIV
    • G01N2333/16HIV-1, HIV-2
    • G01N2333/162HIV-1, HIV-2 env, e.g. gp160, gp110/120, gp41, V3, peptid T, DC4-Binding site
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2469/00Immunoassays for the detection of microorganisms
    • G01N2469/20Detection of antibodies in sample from host which are directed against antigens from microorganisms

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Abstract

艾滋病(尿液、唾液)和毒品多项快速检测试剂盒,是一种同时检测尿液、唾液中艾滋病及多种毒品的液质联用测定方法。其特点为根据样品的实际情况和对灵敏度的不同要求,分别采用双抗原夹心原理和固相萃取,直接沉淀或直接进样的方法对样品进行检测.检测过程在5分钟内完成,应用包括医院、防疫站、出入境检疫局,现场的疾病诊断。家庭自检。用尿液、唾液直接检测,避免血液的交叉感染,彻底解决了实验室检测技术的缺陷,检测无创伤,速度快,方便安全。

Description

艾滋病(尿液、唾液)和毒品多项快速检测试剂盒
1.技术领域
本发明是涉及艾滋病(尿液、唾液)和毒品多项快速检测试剂盒,尤其是能快速判定出被检查者是否感染艾滋病和吸毒的检测试剂。
2.背景技术
当前涉及艾滋病及毒品的案件,其数量呈有增无减的趋势,世界各国都在控制艾滋病的蔓延和缉毒,我国也不例外,因此如何判定被检者是否感染艾滋病和吸食毒品,成为很重要的课题,急待解决。我国目前艾滋病检测主要是血源检测,是用血清.血桨或全血检测.因血液传染性强,医院检验人员进行血检有被感染的危险。所以,发展尿液、唾液检测试剂对检验人员和受检人员都安全,本项目检测用尿液、唾液直接检测,避免血液的交叉感染.该方法不依赖于精密的仪器、不依赖于熟练的技术人员、操作步骤简捷,比起目前常用的酶联免疫法具有更大的优点。整个反应过程约在5分钟内就可以完成。该技术是国际先进水平,在国内该技术处于领先水平。
艾滋病(尿液、唾液)和毒品多项快速检测试剂盒是以尿液、唾液为样本检测抗体,检测过程只需5-10分钟完成。准确率99.6%,特异性100%,灵敏性99%。
3.发明内容
本发明的目的在于公开一种结构简单,检测过程快速准确,应用层析法(LateralFlow Immuno-Assay)胶体金免疫诊断技术的艾滋病(尿液、唾液)和毒品多项检测试剂盒。胶体金检测系统使用一种特殊的多孔膜(NC膜)作为固相抗原或抗体载体。该膜具有很强的蛋白吸附功能,抗原或抗体吸附于NC膜并经干燥处理后即作为固相,可与液相中的相应抗体或抗原快速结合。而在湿润状态下,液相(尿液、唾液)中含有的抗体或抗原可因“灯信引流现象”作快速定向泳动并与固相抗原或抗体结合成为复合物:结合物载体上预先喷点的结合有胶体金(作为显色和指示剂)的相应第二抗体或抗原亦可与该复合物快速结合。由于毛细作用复合物沿线条向前移动,移动至检测线处,复合物被抗人-IgG单克隆抗体捕获形成Au-HIVAg-抗体-抗人-IgG单克隆抗体夹心物,呈现出一条紫红色条带。阴性标本则不会形成夹心物。
由于这种结合过程为物理过程,反应可在数分钟内完成且结合非常稳定。这一技术的创新点为:加有辅助剂使抗原或抗体与固相膜载体牢固结合;应用特殊干燥技术使与固相膜载体结合的蛋白保持稳定,从而达到试剂盒可在常温下保存18个月到1年;胶体金制备和结合技术:胶体金结合物的干燥和在常温下长期保存技术;测试条中各种参试组分的最佳配比:为达到整个测试反应在数分钟内一步完成对测试条中各种原材料的测试选定和参试组分的最佳配比。解决的技术关键问题:(1),以重组抗原构建高灵敏度的双抗原夹心法系统,(2)高灵敏度的双抗原夹心法系统和高灵敏度的双抗体夹心系统中金标记物的制备;(3)尿液、唾液快速采样和样品浓缩技术。
4.具体实施方式
由于这种结合过程为物理过程,反应可在数分钟内完成且结合非常稳定。这一技术的创新点为:加有辅助剂使抗原或抗体与固相膜载体牢固结合;应用特殊干燥技术使与固相膜载体结合的蛋白保持稳定,从而达到试剂盒可在常温下保存18个月到1年;胶体金制备和结合技术:胶体金结合物的干燥和在常温下长期保存技术;测试条中各种参试组分的最佳配比:为达到整个测试反应在数分钟内一步完成对测试条中各种原材料的测试选定和参试组分的最佳配比。解决的技术关键问题:(1),以HIV重组抗原构建高灵敏度的双抗原夹心法系统,用于检测尿液、唾液中的特异性HIV抗体;(2)高灵敏度的双抗原夹心法系统和高灵敏度的双抗体夹心系统中金标记物的制备;(3)尿液、唾液快速采样和样品浓缩技术。

Claims (4)

1.以HIV重组抗原构建高灵敏度的双抗原夹心法系统,用于检测尿液、唾液中的特异性HIV和毒品抗体:高度纯化的重组抗原HIV-1gp41、.P24和HIV-2gp36、高灵敏度的双抗原夹心法系统构建。
2.高灵敏度的双抗原夹心法系统和高灵敏度的双抗体夹心系统中金标记物的制备。
3.上述多个检测系统中金标记物的制备。
4.尿液、唾液的快速样品浓缩技术:尿液、唾液作为待测样品进行检测时,由于尿液、唾液中含有的特异性抗体和抗原的含量要较血清或血浆的多,这就需要该检测系统的灵敏度更强,本项目使用的浓缩垫可使样品在加样瞬间浓缩10-100倍,从而提高检测系统的敏感性。
CN201610901828.3A 2016-10-18 2016-10-18 艾滋病(尿液、唾液)和毒品多项快速检测试剂盒 Pending CN107957493A (zh)

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN201035011Y (zh) * 2007-04-13 2008-03-12 陈洁 艾滋病尿液、唾液快速检测试剂盒
CN101539575A (zh) * 2008-03-17 2009-09-23 陈洁 艾滋病(hiv-1/2)唾液快速检测试剂
EP2856163A1 (en) * 2012-05-30 2015-04-08 Bio-Rad Innovations Method for diagnosing and differentiating hiv-2 infections
CN104515849A (zh) * 2013-10-08 2015-04-15 常州泰晶生物科技有限公司 艾滋病(尿液)和毒品两项快速检测试剂

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN201035011Y (zh) * 2007-04-13 2008-03-12 陈洁 艾滋病尿液、唾液快速检测试剂盒
CN101539575A (zh) * 2008-03-17 2009-09-23 陈洁 艾滋病(hiv-1/2)唾液快速检测试剂
EP2856163A1 (en) * 2012-05-30 2015-04-08 Bio-Rad Innovations Method for diagnosing and differentiating hiv-2 infections
CN104515849A (zh) * 2013-10-08 2015-04-15 常州泰晶生物科技有限公司 艾滋病(尿液)和毒品两项快速检测试剂

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Application publication date: 20180424