SS 656 : 2020

Design, development and validation of miRNA-based diagnostics

  • Edition - 2020

    No. of Pages - 36

  • ICS Classification
    11.100.10 In vitro diagnostic test systems
  • Comments
  • Synopsis
    Describes key considerations for the design, development and performance evaluation of miRNA-based molecular diagnostic assays. Also provides guidance for the development process and the design of the analytical and clinical performance evaluation studies of the assay based on its defined intended purpose(s). Applicable to all miRNA-based diagnostic assays including commercial in vitro diagnostic assays and also for assays developed and used within clinical laboratories for diagnostic purposes.
  • Adoption -
    Status - Current
  • Committee
    Biomedical and Health Standards Committee
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