Hologic SARS-CoV-2/flu assay commercially available

Oct. 28, 2021

Hologic said that its Aptima SARS-CoV-2/Flu Assay is now available commercially for the simultaneous detection and differentiation of three respiratory viruses that can present with overlapping clinical symptoms.

The three viruses — SARS-CoV-2, influenza A and influenza B — typically cause similar symptoms including fever, cough, headache and fatigue. With the potential for seasonal flu in addition to the ongoing COVID-19 pandemic, physicians may want to test patients presenting with these shared symptoms for all three viruses.

Hologic’s new multiplex test is CE-Marked for diagnostic use in Europe, authorized under Interim Order by Health Canada, and has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA).

The assay runs on Hologic’s fully automated Panther system, which provides initial results in approximately three hours and can process more than 1,000 tests in 24 hours.

The Aptima ARS-CoV-2/Flu Assay can be used with both anterior nasal swab and nasopharyngeal sample types. Multiple collection devices can be used, including Hologic’s Direct Load Collection Kits, recently launched in the U.S., which are designed to reduce risk of viral transmission and improve laboratory efficiency. A buffer within the collection tube inactivates SARS-CoV-2 and other common respiratory viruses.

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