US-based in vitro diagnostics firm Quidel has received 510(k) clearance from US Food and Drug Administration (FDA) to market its Lyra parainfluenza assay, a real-time PCR test, to detect and identify human parainfluenza virus (HPIV) infections for virus types 1, 2, or 3 viral RNA, extracted from nasal swab and nasopharyngeal swab specimens.
HPIVs are negative-sense, single-stranded, enveloped RNA viruses and the second leading cause of hospitalisations for respiratory diseases in children under the age of five in the US.
HPIV-1 and HPIV-2 are most often associated with croup and bronchitis in children, while HIPV-3 is more frequently associated with bronchiolitis and pneumonia.
There is no vaccine for HPIV, which commonly infects infants and young children and can infect anyone.
The company’s Lyra parainfluenza assay is part of a new Lyra brand of ready-to-use, molecular PCR reagent kits specifically designed to be compatible with a laboratory’s existing thermocycler.
The Lyra reagent kits feature a short time for results, ready-to-use master mix and the absence of frozen storage of key reagents, as well as other benefits.
The Lyra assays yield highly sensitive, qualitative polymerase chain reaction (PCR) results within 75 minutes.
Quidel president and chief executive officer Douglas Bryant said: "We are delighted to receive 510(k) clearance for yet another Lyra assay.
"Over the last couple of years, we’ve become experts at developing and introducing molecular assays that, like the Lyra parainfluenza assay, offer flexible and distinct workflow advantages over competitive diagnostics."
The company now provides FDA-cleared Lyra assays for 15 different infectious agents, including 11 molecular tests for respiratory diseases and four other PCR assays for other serious infectious disease pathogens.