An emergency use authorization (EUA) by the FDA will allow all CDC-qualified labs across the United States to use a CDC diagnostic panel to test patients for coronavirus. The CDC’s 2019-nCoV Real-Time RT-PCR Diagnostic Panel had previously been limited to use only at CDC labs.
Under this EUA, the use of 2019-nCoV Real-Time RT-PCR Diagnostic Panel is authorized for patients who meet the CDC criteria for 2019-nCoV testing. Testing is limited to qualified laboratories designated by the CDC and, in the US, those certified to perform high complexity tests.
According to the FDA, most confirmed coronavirus infections include fever and/or symptoms of acute respiratory illness but with no commercially available diagnostic tests cleared or approved by the FDA, it was determined that an EUA is crucial to ensure timely access to diagnostics.
Important information about the test:
- The diagnostic is a reverse transcriptase polymerase chain reaction (PCR) test that provides presumptive detection of 2019-nCoV 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 preclude 2019-nCoV 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.
“Since this outbreak first emerged, we’ve been working closely with our partners across the US government and around the globe to expedite the development and availability of critical medical products to help end this outbreak as quickly as possible. 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,” said FDA Commissioner Stephen M. Hahn, MD.
“Our collaboration with the CDC has been vital to rapidly developing and facilitating access to this diagnostic test. The FDA remains deeply committed to utilizing our regulatory tools and leveraging our technical and scientific expertise to advance the availability of critical medical products to respond to this outbreak in the most expeditious, safe and effective manner possible.”
The FDA can issue an EUA to permit the use of certain medical products in time of public health emergency determined by the US Dept of Health and Human Services (HHS) secretary. HHS Secretary Alex Azar declared a public health emergency on Jan 31.
The FDA outlined its approach to expediting the development and availability of critical medical products to prevent, diagnose and treat 2019-nCoV using all applicable regulatory authorities to respond to this outbreak on Jan 27. The agency remains committed to working with developers, international partners and the U.S. government to help support this public health response.
Photo credit: CDC/James Gathany