The new multiplex Covid-19/Flu test is designed to simultaneously detect and differentiate between three respiratory viruses, namely SARS-CoV-2, influenza A and influenza B.
These three viruses cause similar symptoms, which can include headache, fatigue, cough and fever.
The Aptima SARS-CoV-2/Flu assay can detect and differentiate the viruses by using the company’s real-time transcription-mediated amplification (TMA) technology.
It uses nasopharyngeal and nasal swab samples, which can be collected from individuals with symptoms of respiratory infections or who meet Covid-19 clinical and epidemiological criteria.
The assay has obtained Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) and is authorised under Health Canada’s Interim Order. It is also CE-marked for diagnostic use in Europe.
It runs on Hologic’s Panther molecular diagnostics system, which is completely automated, delivers first results in about three hours and has the capability to process more than 1,000 tests in 24 hours.
Hologic diagnostic solutions division president Kevin Thornal said: “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.
“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.”
The company stated that multiple devices can be used for collection, including its Direct Load Collection Kits, which are designed to improve efficiency in laboratories and reduce viral transmission risk.
The new multiplex test development was partly funded with federal funds obtained from the Biomedical Advanced Research and Development Authority; the US Department of Health and Human Services; and the Office of the Assistant Secretary for Preparedness and Response.
Earlier this month, Hologic introduced Novodiag, its molecular diagnostic system for on-demand molecular testing in Europe.