Coronary virus diagnostic reagents get urgent FDA approval

A new coronavirus test has been quickly approved in the U.S. – a diagnostic reagent that can detect the virus has been given the green light of the U.S. Food and Drug Administration (FDA),media slashGear reported. The FDA uses emergency use authorization (EUA) for broader testing, whereas previous diagnoses were limited to official government laboratories.

Coronary virus diagnostic reagents get urgent FDA approval

Although the 2019-nCoV real-time RT-PCR diagnostic reagents have previously been used, they are only used in laboratories of the U.S. Centers for Disease Control and Prevention (CDC). It relies on respiratory secretions obtained from nasopharyngeal swabs or oral swabs tests, and has a so-called reverse transcriptase-polymerase chain reaction that indicates whether the samples came from people infected with the new coronary virus.

Even now, EUA does not mean being able to travel to your local Walgreens or CVS and immediately purchase coronavirus diagnostic reagents. Diagnostic reagents are used only in qualified laboratories assigned to the CDC; It is also worth noting that the test is not foolproof and that 2019-nCoV infection may still exist even if the test results are negative.

“Currently, federal health officials continue to believe that the threat to the general public is relatively low,” the FDA said. “However, the U.S. government is under pressure to accelerate the diagnosis of possible conditions, mainly because of the relatively long incubation period for coronaviruses. The U.S. Department of Health and Human Services (HHS) declared it a public health emergency on January 31, 2020.

EuA is considered a second option because there are no commercially available diagnostic reagents. In fact, the CDC requires these tests to obtain these broader approvals. Anyone who thinks they may be infected with coronavirus should seek advice from a healthcare provider.

The symptoms of the new coronavirus (2019-nCoV) in 2019 are similar to flu, including fever, cough and breathing difficulties. The FDA also works with other diagnostic developers to quickly track more tests and treatmentand and prevention agents that can be used to speed up the process.