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.
"Roche will provide high double-digit millions of tests already in May for countries accepting the CE mark and in the US under Emergency Use Authorisation, further ramping up capacities thereafter", the company said. The test is available on Roche's cobas e analysers which are widely available around the world."
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.
