FDA Provides Emergency Approval for CDC’s Coronavirus Diagnostic Test

by Stephen Riddle
FDA Provides Emergency Approval for CDC’s Coronavirus Diagnostic Test

On Tuesday, the US FDA has granted the use of a diagnostic tool of coronavirus. From now, the CDC-certified laboratories nationwide. Currently, health experts across the CDC-approved facilities will be able to use a diagnostic kit that can recognize the disease. Before this, the so-called 2019-nCoV Real-Time RT-PCR Diagnostic Panel has remained limited to authorized government laboratories like the CDC. But for the latest approval, the Food and Drug Administration has used an EUA (emergency use authorization) to permit broader scale or broader testing. So the screening tool will be broadly available for people from all communities across the US.

The screening tool requires oral and nasal swabs of respiratory secretions. Even more, it functions on the alleged reverse transcriptase-polymerase chain reaction. It indicates whether the specimen belongs to a coronavirus-infected person or not. Well, the FDA approval does not mean that the diagnostic kit will be available at local CVS or Walgreens off the shelf. Thus, to make the tool available, labs need to have a CDC-certification to carry out high complexity examinations. Notably, having an FDA-approval in no way indicates the kit is error-free. Even if it returns a negative result, there might be a 2019-nCoV infection.

Coronavirus has probably spread more horror than it has the real disease at this stage, minimum in the US. The 2019-nCoV or latest coronavirus strain first emerged in December 2019, the City of China Wuhan. The FDA says, currently, government health officials keep on surmising that the infection threatens the entire American people from this virus seems pretty low. Still, the government has remained under pressure to accelerate the screenings for probable cases. Having no off-the-shelf diagnostic test, the emergency use authorization is considered as the better alternative. In fact, the CDC has demanded these broader sanctions for the trial. The health agency recommends people surmising to have a probability of having coronavirus should consult their healthcare professional.

You may also like

Leave a Comment