A METHOD FOR OPTIMIZING AND VALIDATING AN ASSAY FOR DETERMINING THE PRESENCE OR ABSENCE OF A MEDICAL CONDITION
    2.
    发明公开
    A METHOD FOR OPTIMIZING AND VALIDATING AN ASSAY FOR DETERMINING THE PRESENCE OR ABSENCE OF A MEDICAL CONDITION 审中-公开
    优化和验证测试方法用于检测存在或不存在的健康状况的

    公开(公告)号:EP2255017A1

    公开(公告)日:2010-12-01

    申请号:EP09722949.6

    申请日:2009-03-18

    申请人: Epigenomics AG

    发明人: WEISS, Gunter

    IPC分类号: C12Q1/68

    摘要: The invention relates to a method for validation of an assay for determining the presence or absence of a medical condition, wherein the nucleic acid has been treated such that all unmethylated cytosine bases are converted to uracils. According to the invention, the method comprises: a) measuring the concentration of the nucleic acid in biological samples; b) allotting the samples based on the measured concentration of the nucleic acid in the sample to a first sample group if the concentration of the nucleic acid is below a given threshold value, or to a second sample group if the concentration of the nucleic acid is above the given threshold value; c) performing an assay for determining the methylation status of the nucleic acid in the sample obtaining methylation signals, and d) applying a first algorithm to the value if the sample was allotted to the first sample group, or a second algorithm if the sample was allotted to the second sample group.