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June 05, 2020 10:13 AM

CDC develops test to simultaneously detect COVID-19, flu

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    CDC Director Robert Redfield

    The Centers for Disease Control and Prevention has designed a new assay that can simultaneously detect the SARS-CoV-2 coronavirus and the influenza virus, and is seeking emergency use authorization for it from the Food and Drug Administration, CDC Director Robert Redfield told a congressional subcommittee on Thursday.

    In prepared remarks for a hearing before the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies, Redfield said that it is unclear how long the COVID-19 pandemic will last but that "COVID-19 activity will continue for some time." Similarly, the impact the pandemic will have on the upcoming flu season is unclear, but "if there is substantial COVID-19 and seasonal influenza activity at the same time, this could place a tremendous burden on the healthcare system and result in many illnesses, hospitalizations, and deaths."

    Many predict that a second wave of coronavirus cases could hit in the fall during the start of the flu season.

    In preparation for such a scenario, the CDC is seeking emergency use authorization from the FDA for a new assay that can simultaneously detect SARS-CoV-2 and influenza, as "determining if influenza or SARS-CoV-2 is causing the infection is also important to clinical treatment, infection control, and community mitigation efforts," Redfield said.

    As of Thursday afternoon, there were almost 1.9 million cases of COVID-19 confirmed in the U.S. and nearly 109,000 deaths from the disease.

    A couple of diagnostic panels that test for COVID-19 and influenza already exist in the U.S. For example, a PCR-based respiratory panel from BioMérieux's BioFire business that can detect the coronavirus and 20 other viral and bacterial respiratory pathogens, including various influenza A subtypes, received FDA emergency approval in early May. Also, an RT-PCR-based respiratory panel form Qiagen that includes SARS-CoV-2 and 20 other viral and bacterial pathogens, including influenza A and B types, obtained FDA emergency use authorization in March.

    An assay from CDC was the first test to be granted emergency use authorization from the FDA for SARS-CoV-2. Problems quickly arose with the test, however, when some labs reported problems with the reagents and could not implement the test.

    The CDC did not immediately respond to a request for comment on the new test.

    "CDC develops test for simultaneous detection of COVID-19, flu" originally appeared in GenomeWeb.

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