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    REAGENT MANAGEMENT SYSTEM
    2.
    发明公开
    REAGENT MANAGEMENT SYSTEM 审中-公开
    试剂管理系统

    公开(公告)号：EP3078972A1

    公开(公告)日：2016-10-12

    申请号：EP15162612.4

    申请日：2015-04-07

    申请人： F. Hoffmann-La Roche AG ,  Roche Diagnostics GmbH

    发明人： ACKERMANN, Friedrich ,  BOLLIGER, Jean-Pierre ,  CALATZIS, Andreas ,  HARBERS, Rik ,  HUTTER, Roland ,  KITCOFF, Theresa ,  LABUD, Patrick Sascha

    IPC分类号： G01N35/10

    CPC分类号： G01N35/00663 ,  B01L9/00 ,  B01L2200/025 ,  G01N35/00693 ,  G01N35/00722 ,  G01N35/0092 ,  G01N35/04 ,  G01N35/1002 ,  G01N35/1009 ,  G01N35/1016 ,  G01N35/1079 ,  G01N2035/00425 ,  G01N2035/00673 ,  G01N2035/00891 ,  G01N2035/0094 ,  G01N2035/0406 ,  G01N2035/1025

    摘要： A reagent management system (110) is disclosed comprising a reagent container section (112) for receiving reagent containers (7, 8, 9) and a reagent reconstitution device for reconstituting dry, or lyophilized, reagents or concentrated reagents provided in the reagent containers (7, 8, 9) in order to carry out in-vitro diagnostic tests with the reconstituted reagents. The reagent management system (110) further comprises a controller (180) programmed to instruct the reagent reconstitution device to automatically reconstitute an initial total volume of a selected reagent type in one or more reagent containers (7, 8, 9), wherein the initial total volume is calculated based at least on an open container stability time (OCS) of the reconstituted reagent type for each reagent container (7, 8, 9) and on a number of tests that can be carried out within the open container stability time (OCS) of the reconstituted reagent type. A reagent container holder (10) for use by the reagent management system (110) is also disclosed. Methods of automatically reconstituting a dry, or lyophilized reagent, or a concentrated liquid reagent provided in a reagent container (7, 8, 9) in order to carry out an in-vitro diagnostic test with the reconstituted reagent are also disclosed.

    摘要翻译： 公开了一种试剂管理系统（110），其包括用于接收试剂容器（7,8,9）的试剂容器部分（112）以及用于重建设置在试剂容器中的干燥或冻干试剂或浓缩试剂的试剂重构装置 7,8,9），以便用重构试剂进行体外诊断试验。 试剂管理系统（110）还包括控制器（180），其被编程为指示试剂重构装置自动重建一个或多个试剂容器（7,8,9）中的选定试剂类型的初始总体积，其中初始 至少基于每个试剂容器（7,8,9）的重构试剂类型的开放容器稳定时间（OCS）以及可以在开放容器稳定时间内进行的多个测试来计算总体积（ OCS）重构的试剂类型。 还公开了供试剂管理系统（110）使用的试剂容器保持器（10）。 还公开了自动重构干燥或冻干的试剂或提供在试剂容器（7,8,9）中的浓缩液体试剂以便用重构的试剂进行体外诊断测试的方法。

    MEANS AND METHODS FOR UNIVERSAL CALIBRATION OF ANTI-FACTOR Xa TESTS
    3.
    发明公开
    MEANS AND METHODS FOR UNIVERSAL CALIBRATION OF ANTI-FACTOR Xa TESTS 审中-公开
    MITTEL UND VERFAHREN ZUR UNIVERSELLEN KALIBRIERUNG VON ANTI-FAKTOR-XA-TESTS

    公开(公告)号：EP3014282A1

    公开(公告)日：2016-05-04

    申请号：EP14732895.9

    申请日：2014-06-26

    申请人： Roche Diagnostics GmbH ,  F. Hoffmann-La Roche AG

    发明人： ACKERMANN, Friedrich ,  CALATZIS, Andreas

    IPC分类号： G01N33/86 ,  A61K38/48

    CPC分类号： C12Q1/56 ,  C12Y304/21006 ,  G01N33/86 ,  G01N2333/96444 ,  G01N2496/00 ,  G01N2500/20

    摘要： The present invention concerns diagnostic means and methods in the field of coagulation testing. In particular, it relates to a method for determining an anticoagulant activity elicited by a first anticoagulant in a sample of a subject comprising measuring a first Factor Xa activity in a body fluid test sample of said subject, measuring a second Factor Xa activity in at least one calibrator sample comprising a predefined anticoagulation activity for a second anticoagulant, calculating an universal parameter for the anticoagulation activity comprised in the test sample based on the first and the second measured Factor Xa activities and comparing the said parameter for the anticoagulation activity with predefined ranges of expected anticoagulation activity for at least three anticoagulants. Further provided is a computer program code assisting the method as well as a system for carrying out the said method as well as a kit.

    摘要翻译： 本发明涉及凝血试验领域的诊断手段和方法。 具体地，本发明涉及一种用于测定受试者样品中由第一抗凝血剂引起的抗凝血活性的方法，包括测量所述受试者的体液测试样品中的第一因子Xa活性，至少测量第二因子Xa活性 一个校准品样品包含针对第二抗凝血剂的预定抗凝活性，基于第一和第二测量的因子Xa活动计算包含在测试样品中的抗凝活性的通用参数，并将抗凝活性的所述参数与预定义的范围 预期至少有三种抗凝剂的抗凝活性。 还提供了一种辅助该方法的计算机程序代码以及用于执行所述方法的系统以及套件。

    QUALITY CONTROLS OF ANALYZERS FOR BIOLOGICAL SAMPLES
    5.
    发明公开
    QUALITY CONTROLS OF ANALYZERS FOR BIOLOGICAL SAMPLES 审中-公开
    生物样品分析仪的质量控制

    公开(公告)号：EP3217180A1

    公开(公告)日：2017-09-13

    申请号：EP16159744.8

    申请日：2016-03-10

    申请人： F. Hoffmann-La Roche AG ,  Roche Diagnostics GmbH

    发明人： CALATZIS, Andreas ,  DROSS, Felix

    IPC分类号： G01N35/00

    CPC分类号： G01N35/00623

    摘要： In an aspect of the present disclosure a method for monitoring the performance of an analyzer for biological samples having an automated preparation device includes receiving an instruction that a monitoring procedure shall be executed, after receipt of the instruction that a monitoring procedure shall be executed, obtaining, by the automated preparation device, at least two quality control ingredients from a repository including a plurality of quality control ingredients, mixing, by the automated preparation device, the at least two quality control ingredients in a sample preparation receptacle to obtain a quality control which mimics the properties of a biological sample to be analyzed by the analyzer, the method further including determining at least one parameter of the quality control and determining a status of the analyzer based on the determined parameter of the quality control.

    摘要翻译： 在本公开的一个方面中，一种用于监测具有自动制备装置的生物样本的分析仪的性能的方法包括：在接收到将执行监测程序的指令之后，接收应执行监测程序的指令，获得 由所述自动制备设备从包含多种质量控制成分的储存库获取至少两种质量控制成分，由所述自动制备设备将所述至少两种质量控制成分混合在样品制备容器中以获得质量控制，其中 模拟要由分析器分析的生物样品的性质，该方法还包括确定质量控制的至少一个参数并基于确定的质量控制的参数确定分析器的状态。