Meanwhile, the Centers for Disease Control and Prevention (CDC) will this week begin distributing testing kits for nCoV to laboratories across the country. The first 200 kits will be sent to more than 100 qualified labs in the United States with 200 additional kits being shipped to international labs. Each kit can test 700-800 patient samples.
Laboratories are being selected to receive the kits based on their certification to perform high complexity tests. The diagnostic being used 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.
The move is in response to a February 4, 2020 Food and Drug Administration emergency use authorization (EUA) to enable emergency use of the CDC’s 2019-nCoV real time PCR diagnostic panel. To date, this test has been limited to use at CDC laboratories; the authorization last Tuesdya allows the use of the test at any CDC-qualified lab across the country.
The FDA can issue an EUA to permit the use, based on scientific data, of certain medical products that may be effective in diagnosing, treating or preventing such disease or condition when there is a determination, by the Secretary of Health and Human Services (HHS), that there is a public health emergency or a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens, and a declaration that circumstances exist justifying the medical products’ emergency use.
On Jan. 31, HHS Secretary Alex Azar declared a public health emergency recognizing the potential threat that 2019-nCoV poses and reiterating the government’s dedication to leveraging all available resources to help prevent, mitigate and respond to this threat.