RSV

The firm sells a rapid, point-of-care, PCR platform for infectious disease diagnostics, including SARS-CoV-2, influenza, respiratory syncytial virus, and strep A.

The PCR-based panel is designed to simultaneously detect SARS-CoV-2, influenza A and B, and respiratory syncytial virus, with results in less than two hours.

The test kit, which provides results in under two hours, is PCR system-agnostic and is suitable for use with a range of instruments, according to the company.

The PCR test detects SARS-CoV-2, influenza A/B, and respiratory syncytial virus type A and B and runs on the Elite InGenius platform and other major thermcyclers.

The PCR-based kit allows laboratories to test for the diseases, which share clinical symptoms, in approximately three hours.

Cepheid said that the 4-in-1 test runs on any of almost 30,000 GeneXpert Systems, which provide results in approximately 36 minutes.

Qiagen received CE IVD marking for its NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test and for a saliva collection kit for its single-plex NeuMoDx SARS-CoV-2 assay.

The firms previously received CE mark for a COVID-19 test on the BD Max system in March.

The new guidance allows developers to use other transport media and sample types without first obtaining 510(k) clearance.

The RT-PCR-based test, which runs on Becton Dickinson's BD Max system, simultaneously detects SARS-CoV-2, influenza A and B, and respiratory syncytial virus.