The US Food and Drug Administration (FDA) has granted an emergency use authorisation (EUA) status for the first 2019 novel Coronavirus diagnostic test.
The EUA status enables to use the Centers for Disease Control and Prevention’s (CDC) 2019-nCoV Real-Time RT-PCR diagnostic panel at any CDC-qualified lab across the US.
First detected at China’s Wuhan city in December 2019, the 2019-novel Coronavirus (2019-nCoV is a new type of coronavirus that may cause severe respiratory illness in humans.
According to the FDA, most reported cases of 2019-nCoV infection outside of China were associated with the residence in or travel to Wuhan.
With the EUA status, the novel Coronavirus diagnostic test can be used for patients who meet the CDC criteria for 2019-nCoV testing.
The testing is restricted to qualified laboratories designated by the CDC, as well as those certified to conduct high complexity tests.
Coronavirus diagnostic test offers presumptive detection of 2019-nCoV from respiratory secretions
The novel Coronavirus diagnostic is a reverse transcriptase polymerase chain reaction (PCR) test, which offers presumptive detection of 2019-nCoV from respiratory secretions such as nasal or oral swabs.
A positive test result determines the possible infection with 2019-nCoV and infected patients have to work with their health care provider to manage their symptoms and protect the surrounded people.
The Health and Human Services (HHS) secretary Alex Azar announced a public health emergency to better deal with novel Coronavirus outbreak.
The FDA commissioner Dr Stephen Hahn said: “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.
“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.”
Separately, metagenomics technology firm IDbyDNA has rolled out its Explify Respiratory test, which is capable of detecting novel Coronavirus along with 900 other viral, bacterial, fungal and parasitic pathogens.
