February 5, 2020
Yesterday, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) to enable emergency use of the Centers for Disease Control and Prevention’s (CDC) 2019-nCoV (novel coronavirus) Real-Time RT-PCR Diagnostic Panel. To date, this test has been limited to use at CDC laboratories. However, this authorization allows the use of the test at any U.S. CDC-qualified lab and those certified to perform high complexity tests.
According to the FDA, the diagnostic is a reverse transcriptase polymerase chain reaction (PCR) test that provides presumptive detection of the novel coronavirus from respiratory secretions, such as nasal or oral swabs. A positive test result indicates likely infection with 2019-nCoV and infected patients should work with their healthcare provider to manage their symptoms and determine how to best protect the people around them. Negative results do not exclude infection and should not be used as the sole basis for treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history and epidemiological information. The CDC’s interim guidance for healthcare professionals provides recommendations for virus reporting, testing and specimen collection.
The FDA says it is providing the highest level of attention to help expedite the development and review of a variety of medical products to diagnose, treat and prevent the spread of this outbreak.
The Centers for Disease Control and Prevention’s latest Morbidity and Mortality Weekly Report, issued today, focuses on the “Initial Public Health Response and Interim Clinical Guidance for the 2019 Novel Coronavirus Outbreak,” as of Feb. 4.
To date most reported cases of 2019-nCoV infection outside of China have been linked to residence in or travel to Wuhan, China. At this time, federal health officials continue to believe that the threat to the general American population from this virus is relatively low.
Links to a variety of novel coronavirus resources are on IHA’s website.