The Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) that would allow the use of the Centers for Disease Control and Prevention’s (CDC) 2019-nCoV Real-Time RT-PCR Diagnostic Panel by any CDC-qualified lab across the US.
The novel coronavirus diagnostic can be used to test patients who meet the CDC criteria for 2019-nCoV testing. Patients who meet the following criteria should be evaluated as a person under investigation for 2019-nCoV:
- Fever or symptoms of lower respiratory illness and any person, including healthcare workers, who has had close contact with a laboratory-confirmed 2019-nCoV patient within 14 days of symptom onset.
- Fever and signs/symptoms of lower respiratory illness and a history of travel from Hubei Province, China within 14 days of symptom onset.
- Fever and signs/symptoms of a lower respiratory illness and a history of travel from mainland China within 14 days of symptom onset.
According to the CDC, while a positive test result is likely to indicate 2019-nCoV infection, a negative result does not necessarily mean a patient may not have the infection, therefore clinical observation, patient history, and epidemiological information should be used to make patient management decisions.
“Since this outbreak first emerged, we’ve been working closely with our partners across the U.S government and around the globe to expedite the development and availability of critical medical products to help end this outbreak as quickly as possible,” said FDA Commissioner Stephen M. Hahn, MD. “This continues to be an evolving situation and the ability to distribute this diagnostic test to qualified labs is a critical step forward in protecting the public health.”
So far, there have been 12 confirmed cases of 2019-nCoV in the US. States with positive confirmation of the virus include Arizona, California, Illinois, Massachusetts, Washington and Wisconsin. In addition, 36 states are currently reporting people under investigation.
Currently, there is no vaccine for 2019-nCoV although several pharmaceutical companies, including GlaxoSmithKline and Johnson & Johnson, are rapidly working on developing a vaccine candidate. In addition, remdesvir, an experimental antiviral from Gilead, is being tested in patients infected with coronavirus in China.
For more information visit cdc.gov.