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    • 6. 发明申请
    • METHODS AND SYSTEMS FOR INSTRUMENT VALIDATION
    • 仪器验证的方法和系统
    • US20160231245A1
    • 2016-08-11
    • US15016485
    • 2016-02-05
    • LIFE TECHNOLOGIES CORPORATION
    • Thomas WesselYong ChuJacob FreudenthalDavid Woo
    • G01N21/64
    • G01N21/6428G01N21/274G01N21/6452G01N21/6456G01N2021/6439G16B40/00
    • In one exemplary embodiment, a method for validating an instrument is provided. The method includes receiving amplification data from a validation plate to generate a plurality of amplification curves. The validation plate includes a sample of a first quantity and a second quantity, and each amplification curve includes an exponential region. The method further includes determining a set of fluorescence thresholds based on the exponential regions of the plurality of amplification curves and determining, for each fluorescence threshold of the set, a first set of cycle threshold (Ct) values of amplification curves generated from the samples of the first quantity and a second set of Ct values of amplification curves generated from the samples of the second quantity. The method includes calculating if the first and second quantities are sufficiently distinguishable based on Ct values at each of the plurality of fluorescence thresholds.
    • 在一个示例性实施例中,提供了用于验证仪器的方法。 该方法包括从验证板接收放大数据以产生多个扩增曲线。 验证板包括第一数量和第二数量的样本,并且每个扩增曲线包括指数区域。 该方法还包括基于多个扩增曲线的指数区域来确定一组荧光阈值,并且针对该组的每个荧光阈值确定从样品中产生的扩增曲线的第一组循环阈值(Ct)值 从第二数量的样本产生的第一数量和第二组扩增曲线的Ct值。 该方法包括基于多个荧光阈值中的每个荧光阈值处的Ct值来计算第一和第二量是否足够可区分。