Department of Health Awaiting FDA Approval to Perform up to 1,000 Coronavirus Tests Per Day

  • Robert Moore
  • May 19, 2020
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The capacity to perform up to 1,000 coronavirus tests per day may be a matter of weeks away, once the Dept. of Health gains approval from the U.S. Food and Drug Administration (FDA)  which D.O.H. Commissioner Justa Encarnacion said is expected on June 1.

Ms. Encarnacion said the territory is now waiting on the FDA's OK to use the equipment to start performing the tests. “We have received the machine that allows us to test over 1,000 per day. We have the reagents for that machine … we did all the validation tests and now we are waiting for the FDA to give us approval to actually use that machine.”

The capacity to perform a thousand tests a day, with rapid results, does not mean the territory will conduct “mass testing,” Ms. Encarnacion cautioned. Mass testing, she added, is recommended when "you see wide community spread."

Even so, Ms. Encarnacion said D.O.H. has been working on a plan that could include mass testing.

According to the latest numbers, D.O.H. has performed 1,348 tests, 69 of which returned positive, 1,272 negative, 61 recovered, 7 pending and 6 deaths.

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