scope:

This document gives the general requirements for validation and verification of multiplex molecular tests which simultaneously identify two or more nucleic acid target sequences of interest. This document is applicable to all multiplex methods used for examination using IVD medical devices and laboratory developed tests (LDTs). It provides information for both qualitative and quantitative detection of nucleic acid target sequences.

This document is intended as guidance for multiplex examinations that either detect and/or quantify human nucleic acid target sequences or microbial pathogen nucleic acid target sequences from human clinical specimens.

This document is applicable to any molecular in vitro diagnostic (IVD) examination performed by medical laboratories. It is also intended to be used by laboratory customers, IVD developers and manufacturers, biobanks, institutions, and commercial organizations performing biomedical research and regulatory authorities. This document is not applicable to metagenomics.

NOTE An examination procedure developed for a laboratory's own use is often referred to as a "laboratory developed test," "LDT," or "in-house test".