The latest authorisation will enable the use of the test at any CDC-qualified lab in the US
The US Food and Drug Administration (FDA) has issued an emergency use authorisation (EUA) of a diagnostic test for the 2019 novel coronavirus.
Created by the Centers for Disease Control and Prevention (CDC), the 2019-nCoV Real-Time RT-PCR diagnostic panel is a test that has been limited only to CDC laboratories.
The authorisation will enable the use of the test at any CDC-qualified lab in the country.
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.
2019-nCoV diagnostic is a reverse transcriptase polymerase chain reaction (PCR) test
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.
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.
Majority cases of 2019-nCoV infection outside of China were associated with the residence in or travel to Wuhan.
The US Government recently declared a public health emergency even though the threat of the coronavirus in the US remains relatively low according to the federal health officials.
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.”
Recently, UK-based pharmaceutical firm GlaxoSmithKline (GSK) has joined forces with the Coalition for Epidemic Preparedness Innovations (CEPI) to develop a vaccine for the deadly Coronavirus.