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FDA Announces Three EUAs Issued for SARS-CoV-2 and Influenza Combination Testing

FDA maze of regulations

Combination testing EUAs anticipate challenges of upcoming influenza season.

The US Food and Drug Administration (FDA) announced July 2, 2020, the issuance of a third emergency use authorization (EUA) for a combination SARS-CoV-2 and influenza diagnostic test. The EUA for this test, the Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay, was issued to the US Centers for Disease Control and Prevention (CDC) and allows for the detection and differentiation of SARS-CoV-2, influenza A, and influenza B.

FDA Commissioner Stephen M. Hahn, MD, addressed the implications of this new EUA. “With the authorization of these tests, the FDA is helping address concerns in anticipation of this upcoming flu season during the COVID-19 pandemic, which might be especially worrying for some Americans. With just one 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 CDC’s EUA comes after two EUAs for combination testing were granted to German-based QIAGEN GmbH (March 30, 2020) for its QIAstat-Dx Respiratory SARS-CoV-2 Panel, and to BioFire Diagnostics, LLC (May 1, 2020) for its BioFire Respiratory Panel 2.1 (RP2.1). 

SARS-CoV-2 is just one of numerous coronaviruses already in circulation. Qiagen’s EUA detail specifies a list of detection aims: “The QIAstat-Dx Respiratory SARS-CoV-2 Panel is intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the following organism types and subtypes: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, SARS-CoV-2, Human Metapneumovirus A+B, Influenza A, Influenza A H1, Influenza A H3, Influenza A H1N1/pdm09, Influenza B, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Rhinovirus/Enterovirus, Respiratory Syncytial Virus A+B, Bordetella pertussisChlamydophila pneumoniae and Mycoplasma pneumoniae.” 

As stated in BioFire’s EUA letter: “The BioFire Respiratory Panel 2.1 (RP2.1) is intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the following organism types and subtypes identified using the BioFire RP2.1: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, Human Metapneumovirus, Human Rhinovirus/Enterovirus, Influenza A, including subtypes H1, H1-2009, and H3, Influenza B, Parainfluenza Virus 1, Parainfluenza Virus 2, Parainfluenza Virus 3, Parainfluenza Virus 4, Respiratory Syncytial Virus, Bordetella parapertussis (IS1001), Bordetella pertussis (ptxP), Chlamydia pneumoniae, and Mycoplasma pneumoniae.” 

The CDC’s test is differentiated as “a multiplexed nucleic acid test intended for simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A virus, and/or influenza B virus nucleic acids in upper or lower respiratory specimens….,” states its FDA EUA letter. 

As part of the announcements, the FDA emphasized the advantages of combination testing, including decreased patient discomfort, fast and more comprehensive results, reduction in use of supplies and PPE use, and reduced pressure on the supply chain for reagents. The FDA also noted July 2 an update to the Molecular Diagnostic EUA templates (for manufacturers and laboratories) to add information about combination testing.

Related Resources:

FDA Press Release: FDA Authorizes Additional COVID-19 Combination Diagnostic Test Ahead of Flu Season

CDC EUA Letter


BioFire Diagnostics EUA Letter