Qiagen has sought EUA for the test from the FDA. Credit: PDPics / Pixabay.

Netherlands-based Qiagen has launched NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test in Europe to identify and differentiate between common seasonal respiratory infections and Covid-19.

The easy-to-use multiplex polymerase chain reaction (PCR) test detects and differentiates influenzas A and B, respiratory syncytial virus (RSV), and SARS-CoV-2 infections in 80 minutes. 

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Since these viruses produce similar respiratory symptoms, it is crucial to provide differential diagnosis among them for treating patients and for management decisions.

The launch of NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage test in the EU and other markets comes after it obtained CE-IVD registration.

Qiagen has submitted an application to the Food and Drug Administration (FDA) for obtaining emergency use authorisation (EUA) for the test.

The respiratory test uses NeuMoDx 96 and NeuMoDx 288 molecular systems’ automated three-step workflow. 

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

Furthermore, the company has expanded specimen types that can be used on the existing NeuMoDx SARS-CoV-2 test. 

Qiagen obtained CE-IVD approval for the use of saliva samples collected with the NeuMoDx Saliva Collection Kit.

The kit has a collection vial, stabilisation tube and pipette. It helps to perform less invasive sample collection compared to commonly used nasal swabs. 

Qiagen CEO Thierry Bernard said: “Both launch and label extension expand the capabilities of our NeuMoDx systems in detection of Covid-19. 

“They add to our growing NeuMoDx testing menu, which in 2020, included launches for HIV-1, TV/MG, Strep A/C/G, HPV, BK virus, and Influenza A-B/RSV.”

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