Coronavirus / Safety & Health

Covid-19 Antibody Test Gets Emergency FDA Approval


  • Monthly production of tests seen topping 100 million this year
  • Testing is key to identifying people already exposed to virus

Roche Holding AG became the latest company to win emergency U.S. approval for a coronavirus antibody test and promised a fast scale-up of the tool that policy makers hope will smooth the reopening of economies.

The Swiss company expects production of the test to reach the high double-digit millions by June and pass the 100 million monthly threshold later this year. The test looks for antibodies in blood that have been raised to fight off the virus that causes Covid-19.

Roche’s version runs on a high-volume instrument that can produce a single result in 18 minutes and as many as 300 results in an hour, the company said in a statement Sunday after receiving emergency authorization from the U.S. Food and Drug Administration.

“Our people have been working in operations day and night to make sure we have all the products,” Thomas Schinecker, head of Roche’s diagnostics unit, said in a phone interview.

Antibody testing could help pinpoint which people have already been exposed to the virus, potentially giving them some immunity to it. It could also help determine how widely the disease has spread, since the molecular testing that’s been around since January — and used to confirm more than 3 million infections globally — can’t show who had the disease weeks or months ago.

While it’s still unclear how strong immunity will be for different people — or how long it will last — knowing who has already fought off the virus could nonetheless show how vulnerable regions are to future outbreak waves.

Antibody Test

Roche’s antibody test has demonstrated a “specificity” of more than 99.8% and a “sensitivity” of 100% when validated against over 5,000 blood samples taken from people 14 days after their Covid-19 cases were confirmed using molecular testing, Roche said.

If a test can reliably identify positive samples, it’s considered highly sensitive. If it can identify negatives, it’s called specific. That means it knows the difference between Covid-19 antibodies and others raised by, say, another coronavirus that causes the comm

Governments are trying to learn how many people have been exposed to the virus as they wind down social-distancing measures.

Countries including the U.K. and parts of the U.S. were so eager for antibody tests early on that they bought versions that didn’t work. Most of the earliest versions on the market came from small players, but now bigger companies with strong reputations are bringing out their own versions — including Roche and Abbott Laboratories. The U.S. FDA has granted emergency use approval to about a dozen of these tests.

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