3rd Test Detecting Both Flu and COVID-19 Approved
The U.S. Food and Drug Administration (FDA) announced it is assisting healthcare providers to prepare for the 2020-2021 flu season during the COVID-19 pandemic by issuing an emergency use authorizations for diagnostic tests for the detection of viruses that cause COVID-19 disease and influenza.
The FDA stated on July 2, 2020, the Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay is a single test to diagnose infection caused by one of three viruses: SARS-CoV-2, influenza A, and influenza B virus in upper or lower respiratory specimens.
This new assay provides a sensitive, nucleic-acid-based diagnostic tool for the evaluation of specimens from patients in the acute phase of infection.
Furthermore, Flu SC2 offers public health officials information they need to better control the spread of COVID-19 and influenza, which share similar symptoms, during the Fall 2020 flu season.
However, the FDA says negative Flu SC2 Multiplex Assay results do not preclude SARS-CoV-2, influenza A, and/or influenza B infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions.
Negative results must be combined with clinical observations, patient history, and/or epidemiological information, says the CDC.
During the COVID-19 pandemic, state public health laboratories can authorize county or city laboratories in their state to perform testing, says the CDC.
The International Reagent Resource will distribute the Flu SC2 Multiplex Assay and supplies to registered state and local public health laboratories so that they can perform testing with this assay.
The CDC Flu SC2 Multiplex Assay is a quadruplex assay that includes:
- One primer mix and one probe mix. Primers and probes target:
- Virus nucleocapsid (N) gene for specific detection of SARS-CoV-2
- Matrix (M1) gene for specific detection of influenza A virus
- Nonstructural 2 (NS2) gene for specific detection of influenza B virus
- RNase P gene (RP) for specific detection of human nucleic acid that serves as an internal control
This is the 3rd FDA approval of a combination test during 2020. Previously, the FDA issued approvals for:
These single tests diagnose one or more viruses empowering public health laboratories to continue influenza surveillance, while they are also testing for the SARS-CoV-2 virus.
Precision Vaccinations publishes flu season news.