A woman donates blood for a coronavirus antibody test.
Marijan Murat | image alliance | fake pictures
Medical device maker Danaher said Monday that its Covid-19 blood test to detect whether a person had been infected with the new coronavirus received emergency use authorization from the U.S. Food and Drug Administration.
The company’s unit, Beckman Coulter, said it had shipped the antibody tests to nearly 400 U.S. hospitals and laboratories, and has increased production to deliver more than 30 million tests a month.
Antibody tests, which can indicate a certain degree of immunity in those who have had the virus, are considered crucial in reopening economies safely after weeks of blockages.
High demand for the test has led to the entry of several fraudulent kits, prompting the FDA to tighten its rules on testing.
Danaher said his antibody test has a specificity rate of 99.6% and sensitivity of 100%, suggesting very little chance of false positives and no false negatives.
The Abbott Laboratories antibody test has a specificity rate of 99.9%, while the rate is 99.8% for the Roche Holding AG test. Both companies have received FDA emergency use authorization for their tests.
Danaher also said that distribution of his antibody test has begun in other countries that accept approval from the US FDA.
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