The US Food and Drug Administration (FDA) has granted an emergency use authorisation (EUA) for a new diagnostic test capable of detecting of the viruses that cause seasonal flu along with Covid-19.
The US Centres for Disease Control and Prevention (CDC) has secured the approval for the new test, which is aimed at helping health care providers prepare for the upcoming flu season.
The new FDA authorisation marks the third diagnostic test, capable of detecting additional respiratory organisms along with the viruses causing flu and Covid-19, following BioFire Diagnostics and QIAGEN’s diagnostic tests.
FDA Commissioner Stephen M Hahn said: “With the authorization of these tests, the FDA is helping address concerns in anticipation of this upcoming flu season during the COVID-19 pandemic, which might be especially worrying for some Americans. This is another example of the FDA working with test developers to bring important diagnostics to Americans.
“With just one swab or sample, combination tests can be used to get answers to Americans faster. This efficiency can go a long way to providing timely information for those sick with an unknown respiratory ailment.”
Covid-19 combination test avoids the need for multiple samplings
The US regulator said that the combination tests are capable of detecting multiple respiratory diseases, including Covid-19 and the seasonal flu which can show similar symptoms, by testing a single sample from a patient.
The combination testing is said to have several advantages, including the elimination of the need for multiple samplings, resulting in less patient discomfort and more comprehensive results in less time.
In addition, combination tests would require fewer supplies, including swabs and personal protective equipment, and reduces pressure on the supply chain for reagents, said the US regulatory agency.
In March, Qiagen secured the EUA for its QIAstat-Dx respiratory SARS-CoV-2 panel test kit.
Qiagen’s new test is said to differentiate the SARS-CoV-2 coronavirus from 20 other serious respiratory infections in patients who may exhibit similar symptoms in a single testing run of around one hour.
