FDA Authorizes Third Combination Diagnostic Test for Flu and COVID-19

July 6, 2020

The FDA has granted emergency use authorization to an additional combination diagnostic test for influenza and COVID-19.

Officials with the FDA recently issued an emergency use authorization (EUA) for the third diagnostic test for the detection and differentiation of the viruses that cause influenza and coronavirus disease 2019 (COVID-19), according to a press release.1

The Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay is a real-time reverse transcriptase polymerase chain reaction (PT-PCR) test that detects and differentiates RNA from SARS-CoV-2, influenza A virus, and influenza B virus in upper or lower respiratory specimens. The assay provides a sensitive, nucleic-acid-based diagnostic tool for evaluation of specimens from patients in the acute phase of infection.2

The agency previously issued EUAs to BioFire Diagnostics LLC and QIAGEN GmbH for their tests, which include many other respiratory organisms in additions to the viruses that cause flu and COVID-19.1

Related: States Slowly Ease Barriers to Pharmacist-Provided COVID-19 Testing

Combinations tests work by testing a single sample from a patient for multiple respiratory diseases. The dual test allows for ongoing flu surveillance while also testing for COVID-19. Information about both viruses will help public health officials to control the spread of influenza and COVID-19 in the community and may help health care providers manage treatment of influenza and COVID-19, according to the CDC.3 Additionally, combination tests alleviate the need for multiple samplings, which helps facilitate faster and more comprehensive results. Combination tests also require fewer supplies and reduce pressure on the supply chain for reagents, according to the FDA.1

“With the authorization of these tests, the FDA is helping address concerns in anticipation of this upcoming flu season during COVID-19 pandemic, which might be especially worrying for some Americans,” FDA Commissioner Stephen Hahn, MD, said in a statement.1 “With just 1 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.”

The Flu SC2 test kit was evaluated in CDC laboratories and 3 other public health laboratories to ensure that the test works as intended. Test kits will be shipped to public health laboratories when production, including quality control and assembly, has been assembled.2

References

1. Coronavirus (COVID-19) Update: FDA Authorizes Additional COVID-19 Combination Diagnostic Test Ahead of Flu Season. News Release. FDA; July 2, 2020. Accessed July 6, 2020. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-covid-19-combination-diagnostic-test-ahead-flu.

2. CDC. CDC’s Diagnostic Multiplex Assay for Flu and COVID-19 Supplies. Updated July 3, 2020. Accessed July 6, 2020. https://www.cdc.gov/coronavirus/2019-ncov/lab/multiplex.html

3. CDC. CDC Diagnostic Tests for COVID-19. Updated July 3, 2020. Accessed July 6, 2020. https://www.cdc.gov/coronavirus/2019-ncov/lab/testing.html