A Coronavirus Antibody Test That Is More Than 99% Accurate Is Now Cleared for Emergency Use in The US, Easing Concerns of False Positives That Hindered Earlier Tests
May 03, 2020
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A coronavirus antibody test that is more than 99% accurate has been authorized for emergency use in the US, the Swiss drugmaker Roche said Sunday.
The test boasts a 100% sensitivity rating and a 99.8% specificity rating, which is much higher than many of the initial antibody tests to reach market, and could significantly reduce the potential for false positives.
Antibody testing is considered a key step toward reopening the country, as it would offer a better understanding of how widespread the virus is and who may be immune to it.
However, there has still been no definitive study showing having antibodies means people are immune from getting infected. Researchers also do not yet know how long-lasting any antibody protection is for this new virus.
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US regulators authorized Sunday emergency use of a coronavirus antibody test that is more than 99% accurate, addressing concerns about high false positive rates that have plagued some of the first tests.
The test is made by Roche, a Swiss giant in the pharmaceutical and diagnostics industries. Roche said Sunday it will boost its manufacturing to produce "high double-digit millions per month" of the test.