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FDA approves 5 rapid test kits for COVID-19


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The Food and Drug Administration (FDA) has approved the use of five rapid test kits for the detection of the coronavirus disease 2019 (COVID-19).

These point-of-care test kits are registered for use in countries with "reliable" regulatory agencies such as China and Singapore, the FDA said in a statement on Monday.

The FDA also said it has approved the SARS Cov2 kit -- which is PCR-based -- by Gene Xpert from Abbott Laboratories. The latest in the 17 PCR-based test kits approved for commercial use, this kit can detect the virus within five minutes, the agency said.

FDA Director General and Health Undersecretary Eric Domingo urged local government officials, heads of agencies, hospitals, and private companies to be cautious in using the rapid test kits, asking doctors to help in testing and guide patients in interpreting results.

"The rapid test kits will yield a faster result compared to PCR based kits, but it is important that a trained health professional will evaluate and interpret the results. We have to be very cautious in using these rapid test kits because they measure antibodies and not the viral load itself," Domingo said in the statement.

He said a confirmatory PCR-based test is still required.

"A positive result due to cross reaction with other bacteria or viruses is also possible, which is why a confirmatory PCR based test is still required,” Domingo said.

The FDA said it will require the product inserts or label of the rapid test kits to state: “This product is strictly for medical professional use only and not intended for personal use. The administration of the test and interpretation of results should be done by a trained health professional. Confirmatory testing is required.”

As of Sunday, health authorities have recorded 1,418 COVID-19 cases in the Philippines. Of this number, 71 patients have died and 42 have recovered. --Nicole-Anne C. Lagrimas/KBK, GMA News

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