1 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”.