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Roche has obtained emergency approval from the United States sanctuary monitoring agency, Food and Drug Administration (FDA) for an antibody test that determines whether people have been infected with the coronavirus, the Swiss drug maker said Sunday. .
Thomas Schinecker, Roche’s chief diagnostic officer, said the company is targeting more than double its test production, from about 50 million a month to significantly more than 100 million a month by the end of the year.
Governments, businesses and individuals are looking for such blood tests to find out who may have had the disease and who may have some form of immunity, and potentially devise some strategies to help end national quarantines.
Roche, based in Basel, Switzerland, also performs molecular tests to identify active covid-19 infections, and said its antibody test has a specificity rate of over 99.8% and a sensitivity of 100%, which means that Tests show few false positives and no false negatives.
A false positive result can lead to the misleading conclusion that someone has immunity. Roche says the test is based on intravenous blood collection, more accurately than tests using finger pricks.
