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    • 5. 发明申请
    • METHOD FOR REDUCTION OF INTERFERENCES IN IMMUNOASSAYS
    • 降低免疫测定中干扰的方法
    • WO2017093271A1
    • 2017-06-08
    • PCT/EP2016/079170
    • 2016-11-30
    • ROCHE DIAGNOSTICS GMBHF. HOFFMANN-LA ROCHE AGROCHE DIAGNOSTICS OPERATIONS, INC.
    • UPMEIER, BarbaraZARNT, ToralfROESSLER, DieterPOLZ, Johannes
    • G01N33/543
    • G01N33/54393G01N33/54306
    • The invention concerns an immunoassay method for detecting an analyte such as an antigen or an antibody in an isolated sample suspected to contain said analyte by incubating said sample with a plurality of binding partners, one of which carries a detectable label, wherein a label-specific binding partner is added that does not carry a label but binds to said detectable label. The method is applicable for a large variety of analytes and has proven particularly useful for analyte antibodies of the IgG and IgM class present in samples due to infections by pathogens. The invention further concerns a reagent kit useful for said method comprising at least two analyte-specific binding partners one of which carries a detectable label and a label- specific binding partner that binds to said detectable label but itself does not carry a detectable label. In addition, the invention covers the use of a label-specific binding partner that does not carry a detectable label in an in vitro diagnostic test for eliminating interferences caused by anti-label antibodies present in a sample.
    • 本发明涉及一种免疫测定方法,用于通过将所述样品与多种结合伴侣一起温育来检测怀疑含有所述分析物的分离样品中的分析物,例如抗原或抗体,其中一种结合伴侣携带 其中添加了不携带标签但与所述可检测标签结合的标签特异性结合配偶体。 该方法适用于各种各样的分析物,并已被证明对由于病原体感染而存在于样品中的IgG和IgM类分析物抗体特别有用。 本发明还涉及用于所述方法的试剂盒,其包含至少两种分析物特异性结合配偶体,其中一种携带可检测标记和与所述可检测标记结合但本身不携带可检测标记的标记特异性结合配偶体。 此外,本发明涵盖使用在体外诊断测试中不携带可检测标记的标记物特异性结合配偶体,以消除样品中存在的抗标记抗体引起的干扰。
    • 6. 发明申请
    • METHODS FOR REDUCING INTERFERENCES
    • 减少干扰的方法
    • WO2016097116A1
    • 2016-06-23
    • PCT/EP2015/080176
    • 2015-12-17
    • ROCHE DIAGNOSTICS GMBHF. HOFFMANN-LA ROCHE AGROCHE DIAGNOSTICS OPERATIONS, INC.
    • UPMEIER, BarbaraZARNT, ToralfPOLZ, Johannes
    • G01N33/53G01N33/543
    • G01N33/54393G01N33/54306G01N33/6854G01N2800/26
    • The present invention relates to a method for determining an analyte in a sample suspected to comprise said analyte, comprising a) contacting with said sample at least a first and a second capture compound for said analyte, wherein said first and second capture compounds are non- identical capture compounds, and wherein said capture compounds compete in binding to said analyte; b) contacting said capture compounds contacted with said sample with a specifier, wherein said specifier competes in binding to said capture compounds with said analyte; c) determining the amount of complexes comprising said specifier and a capture compound; and d) determining said analyte in a sample based on the result of step c). The present invention further relates to a method for improving the specificity of an indirect immunoassay for determining an analyte, comprising replacing at least 10% of a capture compound by a non-identical capture compound; wherein the capture compound replaced competes in binding to said analyte with the capture compound introduced. The present invention further relates to kits, devices, and uses related to the aforementioned methods.
    • 本发明涉及一种用于确定怀疑含有所述分析物的样品中的分析物的方法,包括a)与所述样品至少接触所述分析物的第一和第二捕获化合物,其中所述第一和第二捕获化合物是非 - 相同的捕获化合物,并且其中所述捕获化合物竞争结合所述分析物; b)使与所述样品接触的所述捕获化合物与指定剂接触,其中所述说明符与所述分析物竞争结合所述捕获化合物; c)确定包含所述说明符和捕获化合物的复合物的量; 以及d)基于步骤c)的结果确定样品中的所述分析物。 本发明还涉及一种用于改进用于确定分析物的间接免疫测定的特异性的方法,其包括用非相同捕获化合物代替至少10%的捕获化合物; 其中捕获化合物用引入的捕获化合物取代与所述分析物结合的竞争。 本发明还涉及与上述方法相关的试剂盒,装置和用途。
    • 7. 发明申请
    • RECOMBINANT TRYPANOSOMA CRUZI JL7 ANTIGEN VARIANTS AND THEIR USE FOR DETECTING CHAGAS DISEASE
    • 重组人TRYPANOSOMA CRUZI JL7抗原变异体及其检测CHAGAS疾病的用途
    • WO2016071393A1
    • 2016-05-12
    • PCT/EP2015/075692
    • 2015-11-04
    • ROCHE DIAGNOSTICS GMBHF. HOFFMANN-LA ROCHE AGROCHE DIAGNOSTICS OPERATIONS, INC.
    • ROESSLER, DieterUPMEIER, BarbaraZARNT, Toralf
    • G01N33/569
    • G01N33/56905C07K14/44C07K2319/21C07K2319/40C07K2319/70G01N33/564G01N2333/44G01N2469/20G01N2800/26
    • The invention concerns variants of JL7 antigens that are suitable for detecting antibodies against Trypanosoma cruzi (causing Chagas disease) in an isolated biological sample. These antigens comprise a JL7 specific amino acid sequence, said JL7 specific sequence consisting of two copies of SEQ ID NO. 2, wherein each of said two copies has an amino acid identity of at least 90% to SEQ ID NO.2 and wherein no further Trypanosoma cruzi specific amino acid sequences are present in said polypeptide. The invention also concerns a composition of polypeptides useful for the detection of antibodies against Trypanosoma cruzi that comprises the above characterized JL7 antigen along with at least one of T. cruzi polypeptides 1F8, Cruzipain, KMP-11 and PAR-2. Moreover, it relates to a method for producing JL7 antigen as well as to diagnostic methods for detecting T. cruzi antibodies using the JL7 polypeptide. In addition, the invention concerns a reagent kit comprising said JL7 polypeptides or composition of Trypanosoma cruzi polypeptides.
    • 本发明涉及适合于在分离的生物样品中检测针对克氏锥虫(引起恰加斯病)的抗体的JL7抗原的变体。 这些抗原包含JL7特异性氨基酸序列,所述JL7特异性序列由两个拷贝的SEQ ID NO: 2,其中所述两个拷贝中的每一个与SEQ ID NO.2具有至少90%的氨基酸同一性,并且其中在所述多肽中不存在进一步的锥虫特异性氨基酸序列。 本发明还涉及可用于检测针对锥虫的抗体的多肽的组合物,其包含上述特征的JL7抗原以及至少一种克氏锥虫多肽1F8,Cruzipain,KMP-11和PAR-2。 此外,本发明涉及生产JL7抗原的方法以及使用JL7多肽检测克氏锥虫抗体的诊断方法。 此外,本发明涉及包含所述JL7多肽或克氏锥虫多肽组合物的试剂盒。
    • 9. 发明申请
    • PRETREATMENT METHOD FOR RAPID DETECTION OF HCV CORE ANTIGEN
    • 快速检测HCV核心抗原的预处理方法
    • WO2017207595A1
    • 2017-12-07
    • PCT/EP2017/063077
    • 2017-05-31
    • ROCHE DIAGNOSTICS GMBHF. HOFFMANN-LA ROCHE AGROCHE DIAGNOSTICS OPERATIONS, INC.
    • UPMEIER, BarbaraZARNT, ToralfGINTER, ManfredBOLLHAGEN, Ralf
    • G01N33/576
    • The present invention relates to a method for detecting acore polypeptide of a hepatitis C virus (HCV) in a sample from a subject comprising (a) contacting said sample with a surfactant comprising a cationic detergent; (b) contacting said sample with a binding com- pound; and (c) detecting a core polypeptide of said HCV in said sample; wherein step a) is immediately followed by step b). The present invention further relates to a method for pre- processing a sample from a subject for detection of an HCV core polypeptide, comprising (a) contacting said sample with a surfactant comprising a cationic detergent and, optionally, with an agent inducing a pH shift, immediately followed by (b) contacting said sample with a binding compound. Moreover, the present invention further relates to uses, devices, and analytical systems related to aforesaid methods.
    • 本发明涉及用于检测来自受试者的样品中丙型肝炎病毒(HCV)的acore多肽的方法,其包括(a)使所述样品与包含阳离子去污剂的表面活性剂接触; (b)使所述样品与结合化合物接触; 和(c)检测所述样品中所述HCV的核心多肽; 其中步骤a)紧接着步骤b)。 本发明进一步涉及用于预处理来自受试者的样品以检测HCV核心多肽的方法,其包括(a)使所述样品与包含阳离子去污剂的表面活性剂接触,并任选地与诱导pH转移的试剂 紧接着(b)使所述样品与结合化合物接触。 此外,本发明还涉及与上述方法有关的用途,装置和分析系统。