Chembio’s antibody test is the first to have its authorisation revoked. It might not be the last.
Robust specificity data mark Roche’s serological test out as a major competitor.
With the prevalence of coronavirus infection running at about 5%, test manufacturers and regulators alike will have to guard against false positives.
The FDA is loosening its rules on the authorisation of diagnostic tests for the new coronavirus, but it is still some way behind Europe.