FDA clears Cepheid Xpert Xpress Flu/RSV test

30 July 2018 (Last Updated July 30th, 2018 10:46)

Molecular diagnostics company Cepheid has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Xpert Xpress Flu/RSV test in near-patient settings.

FDA clears Cepheid Xpert Xpress Flu/RSV test
Scanning electron micrograph of human respiratory syncytial virus (RSV) virions. Credit: NIH Image Gallery.

Molecular diagnostics company Cepheid has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Xpert Xpress Flu/RSV test in near-patient settings.

Xpert Xpress Flu/RSV test has also gained Clinical Laboratory Improvement Amendments (CLIA) waiver.

The test leverages automated real-time reverse transcription polymerase chain reaction (RT-PCR) to quickly and accurately detect influenza A and B viruses, and the RNA of respiratory syncytial virus (RSV) in patient samples within 20 minutes.

“Cepheid claims that its Xpert Xpress Flu/RSV, Flu and Strep A tests offer medically actionable and timely information needed to support better patient management, and antibiotic and antiviral stewardship.”

Its capability to identify multiple RNA segments is said to improve strain coverage and prevent loss of sensitivity in case of natural variations of the influenza virus.

According to the company, the onboard reagents offer high-performance specifications and do not need any additional confirmation testing.

The test can be used with nasopharyngeal (NP) and nasal swab specimens, which are considered less invasive compared to NP swabs, allowing more comfortable specimen collection experience for patients.

Cepheid chief medical and technology officer David Persing said: “Reflecting on the enormous impact of the last flu season, we are pleased to announce the launch of Cepheid’s third CLIA-waived respiratory test: Xpert Xpress Flu/RSV.

“Our family of CLIA-waived Xpert Xpress tests allows laboratories to expand their capacity by extending standardised testing for flu, RSV, and Strep A to near-patient and point-of-care settings.”

According to the World Health Organization (WHO), the upper respiratory tract infections are the most common reason for antimicrobial use.

However, the majority of these infections are viral and do not require antimicrobial therapy.

Cepheid claims that its Xpert Xpress Flu/RSV, Flu and Strep A tests offer medically actionable and timely information needed to support better patient management, and antibiotic and antiviral stewardship.