Roche has won emergency approval from the FDA for an antibody test to determine whether people have ever been infected with the coronavirus, the Swiss drugmaker said.
Abbott has said the specificity and sensitivity of its test are 99.5 percent and 100 percent respectively. Diasorin has said its Liason XL test has 97.4 percent sensitivity and 98.5 percent specificity.
As demand escalates for antibody tests, an array of distributors with no background or established testing competency have also joined the experienced companies in an all-but-unregulated marketplace in the United States, according to a Reuters investigation.Schinecker foresees a high need for testing healthcare workers and their families for exposure, and those who showed signs and symptoms, to see if they have antibodies.
"Since this virus is not well known, one can hypothesize, but the proof will take longer," he said."Testing these people ... is key to seeing whether or not people really have developed immunity."
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