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October 4, 2021

FDA grants EUA to LabCorp’s SARS-CoV-2 and flu detection combo kit

The combo kit can simultaneously detect and differentiate the SARS-CoV-2, influenza A and influenza B viruses.

The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to the combined at-home collection test kit for Covid-19 and influenza A/B from life sciences company LabCorp.

The new kit is intended for individuals aged two years and above and utilises Roche Cobas SARS-CoV-2 & influenza A/B Test for use on the Cobas 6800/8800 Systems.

It is a multiplex reverse transcription-polymerase chain reaction (RT-PCR) assay that can simultaneously detect and differentiate the SARS-CoV-2, influenza A and influenza B viruses.

The Cobas SARS-CoV-2 & influenza A/B Test uses nasal or nasopharyngeal swab samples, which can be collected from individuals with suspected respiratory infections.

It helps people to test for both flu and Covid-19 with the aim to prevent the risk of further spreading of the virus to others.

The kit uses a short nasal swab which makes it comfortable and easier for individuals to cmplete at-home sample collection.

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Labcorp Diagnostics chief medical officer and president Brian Caveney said: “Our newest home collection kit makes it convenient for individuals, including children over the age of two, to take the test in the safety of their homes.

“In time for flu season, the single test helps doctors and individuals make more informed treatment decisions given that symptoms of Covid-19 and flu are similar.”

The new kit will be available for free to individuals who meet clinical guidelines, which may include experiencing symptoms, being exposed to a Covid-19 patient or being recommended for testing by a healthcare provider.

The company noted that the Cobas SARS-CoV-2 & influenza A/B Test will become available from this month and can be ordered either through Pixel by Labcorp or from electronic medical record systems by physicians.

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