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November 3, 2021updated 16 Feb 2022 6:34am

Qiagen obtains CE mark for Flu A-B/RSV/SARS-CoV-2 test

The new RT-PCR multiplex test helps clinicians make the right treatment decisions.

Qiagen has obtained CE mark for its QIAstat-Dx Respiratory 4 Plex Flu A-B/RSV/SARS-CoV-2 test and plans to launch it in the European market soon.

The new polymerase chain reaction (RT-PCR) multiplex test is designed to detect and differentiate between SARS-CoV-2, respiratory syncytial virus (RSV), and influenza A and B.

With an easy-to-use QIAstat-Dx modular cartridge-based system, the new test delivers results in roughly one hour and eliminates the need for additional sample preparation.

The syndromic test helps clinicians make the right treatment decisions by identifying whether a patient has common seasonal respiratory infections or SARS-CoV-2.

These viruses have similar respiratory symptoms, making it difficult for clinicians to identify the exact respiratory infection a patient is suffering from without a test result.

The new Respiratory 4 Plex Flu A-B/RSV/SARS-CoV-2 test expands the company’s portfolio of PCR solutions for Covid-19.

Qiagen molecular diagnostics business area and corporate business development senior vice-president Jean-Pascal Viola said: “This new test expands the capabilities of our QIAstat-Dx system with a much-needed COVID-19 application that differentiates between respiratory infections quickly without lab infrastructure.

“With flu season and Covid-19 case numbers still high, this test provides a crucial tool that can be used close to patients and in decentralised environments like intensive care units (ICUs), emergency rooms and satellite labs. By adding this new test to our growing QIAstat-Dx testing menu, we are taking another step to increase the platform’s value for customers beyond the pandemic.”

At present, the company offers the QIAstat-Dx Gastrointestinal and QIAstat-Dx Respiratory+ tests.

It also has a portfolio of additional tests that are currently under development, including a test for Meningitis.

In August, Qiagen’s rapid and portable QIAreach SARS-CoV-2 Antigen Test received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA).

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