Diagnostic solutions provider Quidel has received 510(k) approval from the US Food and Drug Administration (FDA) for its Lyra Adenovirus Assay.
Lyra Adenovirus Assay is a real-time PCR test, which was developed for the qualitative detection of human adenovirus (HAdV) viral DNA isolated from nasal swab and nasopharyngeal swab specimens.
Quidel president and CEO Douglas Bryant said: "We are pleased to receive 510(k) clearance for our Lyra Adenovirus Assay."
"This assay adds depth to our molecular respiratory solutions, and when paired with our other Lyra assays, provides customers with the power to customize their testing strategies in response to their unique local or seasonal prevalence demands."
The company is offering Lyra assays for a dozen different infectious agents, including eight molecular tests for respiratory disease, (Strep A, Strep C+G, Influenza A, Influenza B, human metapneumovirus (hMPV), respiratory syncytial virus (RSV), and adenovirus (HAdV).
In addition, four other PCR assays are available for serious infectious disease pathogens (herpes simplex virus (HSV) types 1 and 2, varicella zoster virus (VZV) and C. difficile).
Adenovirus infections may result in various illnesses such as colds, sore throat, bronchitis, pneumonia, diarrhea, pink eye and fever.