FDA APPROVES RAPID ANTIBODY TEST KITS FOR COVID-19

PRESS STATEMENT
30 March 2020

The Food and Drug Administration (FDA) approves the use of five (5) Rapid Test Kits for COVID-19 today, March 30, 2020. The FDA supports all efforts to address this pandemic. These point-of-care test kits are registered for use in countries with reliable regulatory agencies such as China and Singapore. “We approve kits that are registered and used in countries with advanced technology and wide experience with COVID 19. We want the people to have access to testing but of course, proper evaluation and safeguards will still be in place” Director General Eric Domingo said.

FDA has also approved the SARS Cov2 kit by Gene Xpert. This kit is PCR based. To date, FDA has approved 17 PCR based test kits for commercial use.

As a safety precaution, the FDA shall require the product inserts or label of the Rapid Test Kits to state the following: “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.” 

“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. The body takes time to develop antibodies and this might give a negative result for patients who have been infected but have not yet developed antibodies. 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,” DG Domingo added.

FDA calls on the local government chief executives, heads of agencies, hospitals and private companies to be cautious in using these test kits. The agency asks doctors to help in testing and guide patients in the interpretation of the results. He also stressed the need for the Department of Health to increase the number of capable laboratories accredited to perform the PCR confirmatory tests.

FDA remains steadfast in its obligation to protect the public. Despite the global crisis we are faced with, FDA continues to safeguard public health by ensuring that health commodities, especially those related to addressing the COVID 19 emergency, are certified following regulatory standards – through streamlined processes.

“Let us remain vigilant and hopeful as we protect each other’s welfare against those who seem to take advantage of this vulnerable situation. During this rapid increase of COVID-19 cases in the country, the agency continues to serve the people by giving them access to testing without compromising our mandate of ensuring the safety, efficacy and quality of every health product for the public,” DG Domingo concluded.

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