February 26, 2021, 5:04

FDA Gives Roche Emergency Use Approval for Antibody Tests

FDA Gives Roche Emergency Use Approval for Antibody Tests

The purpose of antibody testing is to determine whether a person has ever been exposed to the virus and if he has developed antibodies, meaning immunity to it.

The US Food and Drug Administration has granted the Swiss drugmaker Roche Holding AG emergency use approval for antibody testing to see if an individual has ever been infected with COVID-19, the company announced on Sunday.

It also noted that the true negative rate (specificity) of the serology test exceeds 99.8 percent, while its true positive rate (sensitivity) reaches 100 percent.

The number of COVID-19-related deaths throughout the world has surpassed 247,000, more than 3,500,000 cases of the infection have been registered, according to the US-based Johns Hopkins University, which tracks and compiles data from federal and local authorities, media and other sources. Over 1 million have recovered.

Sourse: sputniknews.com

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