- Defined by the FDA as “a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture.”
- Use molecular testing to detect and identify combinations of as many as two dozen viruses.
- Only one large multiplex panel approved by the FDA: the Luminex xTAG Respiratory Virus Panel.
- Approved tests on Luminex menu: influenza A and B, influenza A subtype H1 (seasonal) and H3 (seasonal), respiratory syncytial virus, parainfluenza 1, 2, 3 viruses, human metapneumovirus, rhinovirus, and adenovirus.
- Tests on Luminex menu for research only: parainfluenza 4, coronavirus (HKU1, NL63, OC43, 229E), enterovirus, and avian flu H5 subtype.
- Smaller panels approved by the FDA: GenProbe Prodesse’s ProFlu+, which detects influenza A/B and respiratory syncytial virus; GenProbe Prodesse’s ProParaflu+, which detects parainfluenza 1, 2, 3 viruses; and Nanosphere’s Verigene RVNATSP, which was granted a CLIA moderate-complexity designation in March and detects influenza A/B and respiratory syncytial virus.
- Other large multiplex RVPs awaiting FDA approval: Qiagen’s ResPlex II RVP, Seegene’s Seeplex Respiratory Pathogen Assay (which also detects five pneumonia bacteria), Osmetech’s eSensor XT8, and AutoGenomics’ Infinity RVP Plus. EraGen Biosciences’ MultiCode PLx RVP became unavailable after Luminex withdrew rights to use the Luminex platform, but EraGen has arranged to use Illumina’s BeadXPress platform and is working on a commercial release.
- In October 2009, the FDA announced class II special controls that would apply to multiplex RVPs.