US FDA clears Quidel’s new diagnostic assay for RSV and hMPV

19 October 2017 (Last Updated October 23rd, 2017 16:08)

Diagnostic testing solutions provider Quidel has obtained marketing approval from the US Food and Drug Administration (FDA) for its Solana respiratory syncytial virus (RSV) + human metapneumovirus (hMPV) Assay for the diagnosis of RSV and/or hMPV infections.

Diagnostic testing solutions provider Quidel has obtained marketing approval from the US Food and Drug Administration (FDA) for its Solana respiratory syncytial virus (RSV) + human metapneumovirus (hMPV) Assay for the diagnosis of RSV and/or hMPV infections.

Indicated for use in the Solana instrument, the assay is designed to detect nucleic acids extracted from nasal and nasopharyngeal swabs of patients having signs and symptoms of a respiratory infection.

The assay uses a new Reverse-Transcriptase Helicase-Dependent Amplification (HDA) for the generation of a rapid and accurate test result within 45 minutes.

Quidel president and CEO Douglas Bryant said: “We are pleased to introduce an additional innovative, rapid testing solution that addresses the leading cause of viral respiratory infections in both the young and elderly, RSV and hMPV.

“The easy-to-use molecular test does not require prior RNA extraction.”

“This economic and focused approach to testing to detect and differentiate these infections replaces expensive syndromic panels or laboratories capable of performing high-complexity testing.”

Bryant further added that the easy-to-use molecular test does not require prior RNA extraction.

The ability of Solana to process up to 12 samples in a single 45-minute run is expected to offer time-saving and workflow advantages in moderately complex settings.

With CE-Mark obtained in August this year, the RSV + hMPV assay expands the firm’s Solana platform, which includes tests for the detection of various infections such as Clostridium difficile, Group A β-hemolytic Streptococcus, Herpes simplex virus 1 (HSV-1), influenza A and B, and trichomonas.