From Hologic Inc., the Aptima SARS-CoV-2/Flu Assay is, a multiplex COVID-19/flu test, now available in North America and Europe 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.1 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 multiplex COVID-19/flu test is CE-Marked for diagnostic use in Europe, authorized under Interim Order by Health Canada, and has received emergency use authorization from the U.S. Food and Drug Administration. 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.

“Our new assay will provide greater flexibility and testing options for labs and healthcare providers as we head into what is typically flu season in the United States,” says Kevin Thornal, president of the Diagnostic Solutions Division at Hologic. “Because our Panther instruments are so widely placed in clinical labs across the country, the launch of this test will help deliver results where and when they are needed.”

Multiplex COVID-19/Flu Test Available on Panther

To date, Hologic has provided more than 100 million SARS-CoV-2 assays to its laboratory customers. More than 2,700 Panther systems are installed in clinical diagnostic laboratories around the world, according to the company.

“Our new SARS-CoV-2/Flu assay is a valuable option for healthcare systems by providing the ability to detect multiple infectious agents simultaneously,” says Jan Verstreken, group president, International at Hologic. “Hologic has been consistently at the forefront of public health needs during the current pandemic by providing fully automated testing capabilities to address the global situation.”

The Aptima SARS-CoV-2/Flu Assay, multiplex COVID-19/flu test, 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 United States, 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. Then the tubes are loaded directly onto the Panther instrument without any manual steps, which reduces human error and repetitive motion injuries, according to the company.

Development of the Aptima SARS-CoV-2/Flu Assay was funded in part with federal funds from the U.S. Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number 75A50120P00100.

For more information, visit Hologic.

Featured Image: The Aptima SARS-CoV-2/Flu Assay can be used with both anterior nasal swab and nasopharyngeal sample types. Photo: Hologic Inc.


1. Overview of testing for SARS-CoV-2 (COVID-19). Centers for Disease Control and Prevention. Updated Oct. 22, 2021. Accessed October 26, 2021.