scope:

This document gives the general requirements for interpretation and reporting 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 in vitro diagnostic (IVD) medical devices and laboratory developed tests (LDTs). It provides information for both of qualitative/quantitative detection of nucleic acid target sequences.

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

This document is applicable to any molecular IVD examination performed by medical laboratories. It is also intended to be used by laboratory customers, IVD developers and manufacturers, biobanks, institutions, commercial organizations performing biomedical research, and regulatory authorities. This document is not applicable to metagenomic massive parallel sequencing (MPS), but applicable to multiplex molecular methods including 16S sequencing.

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".