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US FDA Takes Significant Step in Coronavirus Response Efforts, Issues Emergency Use Centers for the Disease Control and Prevention’s (CDC) 2019-nCoV Real-Time RT-PCR Diagnostic Panel

Feb 04, 2020: U.S Food and Drug Administration issued an emergency use authorization (EUA) to enable emergency use of the Centers for the Disease Control and Prevention’s (CDC) 2019-nCoV Real-Time RT-PCR Diagnostic Panel.

To date, this test has been limited to use at the CDC laboratories; today’s authorization allows the use of the test at any CDC-qualified lab across the country.

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The 2019-novel coronavirus (2019-nCoV), recognized in Wuhan, China in December 2019, is a new type of coronavirus that can cause severe respiratory illness in the humans.

The majority of patients with the confirmed 2019-nCoV infection have developed a fever and/or symptoms of the acute respiratory illness (e.g., cough, difficulty breathing). However, limited information is currently available to characterize the full spectrum of a clinical illness associated with 2019-nCoV infection.

To date, most reported cases of 2019-nCoV infection outside of China have been linked to the residence in or travel to Wuhan, China.  At present federal health officials continue to the believe that the threat to the general American population from this virus is relatively low.

Under this EUA, the use of 2019-nCoV Real-Time RT-PCR Diagnostic Panel is authorized for the patients who meet the CDC criteria for 2019-nCoV testing. Testing is limited to the qualified laboratories designated by the CDC and, in the U.S., those certified to perform high complexity tests.

The diagnostic is 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 the infected patients should work with their health care provider in order to manage their symptoms and determine how to best protect the people around them.

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 the leveraging all available resources in order to help prevent, mitigate and respond to this threat.

https://fda.einnews.com/pr_news/508896807/fda-takes-significant-step-in-coronavirus-response-efforts-issues-emergency-use-authorization-for-the-first-2019-novel-coronavirus-diagnostic

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