SS 656:2020

Design, development and validation of miRNA-based diagnostics


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.




Status Current
Edition 2020
No. of Pages 36
ICS Classification 11.100.10 In vitro diagnostic test systems
Committee Biomedical and Health Standards Committee
Available for Purchase Global
Adoption -