ISO/FDIS 21474-3

In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 3: Interpretation and reports

Scope

This document gives general requirements for interpretation and reports of multiplex molecular tests using IVD medical devices and laboratory developed tests (LDTs), including qualitative/quantitative detection of nucleic acid targets.
This document is applicable to all the methods that are used for IVD medical devices and LDTs that measure two or more nucleic acid targets of interest. This document is intended for multiplex assays that evaluate human nucleic acid targets, and detection of microbial pathogens in the background of human genome directly from clinical specimens.