The market for COVID-19 antibody tests is red-hot. It has ballooned in a matter of months as hundreds of products flood the world for people who want to find out whether they've already had the virus.
BRUSSELS - The market for COVID-19 antibody tests is red-hot. It has ballooned in a matter of months as hundreds of products flood the world for people who want to find out whether they’ve already had the virus.
At least nine of them are no longer allowed to be sold in the United States, according to a Reuters analysis of public data from the Food and Drug Administration, which clamped down on the sector last month. Guidance setting out minimum performance criteria for tests could also be adopted, the two regulatory sources told Reuters. Under current rules, kits can carry a CE mark regardless of their accuracy.
It’s a potentially lucrative business: testing about 450 million people in the EU would cost billions of euros based on such prices. “The test results are not reliable. The percentage of false positive and false negative results is too high,” the study concluded, without naming the manufacturers.
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