FDA grants EUA to QIAGEN’s NeuMoDx Flu A-B/RSV/SARS-CoV-2 test
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FDA grants EUA to QIAGEN’s multiplex test

29 Mar 2021

The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to QIAGEN’s NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay, expanding its Covid-19 portfolio.

FDA grants EUA to QIAGEN’s multiplex test
As clinical signs and symptoms of SARS-CoV-2, influenza or RSV are similar, it is vital to correctly detect them. Credit: Ewa Urban from Pixabay.

The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to QIAGEN’s NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay, expanding its Covid-19 portfolio.

This polymerase chain reaction (PCR) multiplex test can aid in both qualitative detection and differentiation of influenzas A and B, respiratory syncytial virus (RSV) and SARS-CoV-2 infections within 80 minutes.

With Covid-19 restrictions being eased and social distancing measures reduced, the chances of respiratory viral infections are expected to increase, QIAGEN noted.

As clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2, influenza or RSV can be similar, it is vital to correctly detect them for treating and managing patients accordingly, especially during the Covid-19 pandemic.

The NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay uses the high-throughput, automated three-step workflow of the NeuMoDx 96 and NeuMoDx 288 molecular systems.

It also has additional system features such as processing capacity, true random access and continuous loading of samples, reagents and consumables while the system is running.

QIAGEN senior vice-president Jean-Pascal Viola said: “This test will play an important role in differentiating between influenza-like illnesses (ILI) while the burden of COVID-19 continues.

“With its ease of use and true random access, the NeuMoDx will help laboratories maintain throughput for this increased testing volume while continuing routine testing.”

The new 4-plex test adds to the expanding menu of assays on the NeuMoDx platform, which includes tests for blood-borne viruses, sexual and reproductive health, and transplant and immunocompromised disease areas.

Last November, QIAGEN launched the test in the European Union and other markets that accept CE-IVD. With the latest EUA, it will begin marketing the test in the US.