The USFDA has issued an emergency use authorization (EUA) to enable emergency use of the Centres for Disease Control and Prevention’s (CDC) 2019-nCoV Real-Time PCR Diagnostic Panel to be done at any CDC-qualified labs in the US. The diagnostic test is a reverse transcriptase-polymerase chain reaction (RTPCR) that provides speculative detection of the 2019-nCoV from respiratory secretions. This test is intended for use with upper and lower respiratory specimens collected from persons who meet CDC criteria for 2019-nCoV testing.
FDA has issued this EUA recognizing the public health emergency due to the global outbreak of 2019-nCoV and reiterating the government’s dedication to leveraging all available resources to help prevent, mitigate and respond to this threat as early as possible. The EUA process enables FDA to consider and authorize the use of unapproved, but potentially life-saving…
