FDA okays rapid test kits for COVID-19

IN support of efforts to address the coronavirus disease 2019 (COVID-19) pandemic, the Food and Drug Administration has approved the use of five rapid test kits for the disease.

Health Undersecretary Eric Domingo, FDA Director General, said the point-of-care test kits are registered for use in countries with reliable regulatory agencies such as China and Singapore.

“We approve test 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,” he said.

Domingo said the FDA has also approved the SARS Cov2 kit by Gene Xpert from Abbott Laboratories which can detect the virus within five minutes. This test kit is PCR based. To date FDA has approved 17 PCR based test kits for commercial use.

Health Secretary Francisco T. Duque III earlier explained that the low number of tests conducted is because the Department of Health is using PCR based test kits which take longer to process because they involve live viruses and samples have to be processed by machines. He added rapid tests kits, which measure antibodies and could yield faster results, could be used but they could not be used for definitive diagnosis since some patients may take time to develop antibodies.

The FDA also said the rapid test kits will yield a faster result compared to PCR based kits, but it is not conclusive hence, it is important that a trained health professional will evaluate and interpret the results and a confirmatory testing using a PCR-based test kit will be done for definitive diagnosis.

“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. The results of the rapid test kits would serve as guide for doctors. The use of PCR based test kits is still better though it takes longer to get the result,” Domingo said.

He added that 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 the results should be done by a trained health professional. Confirmatory testing is required.”

The FDA called on local government chief executives, heads of agencies, hospitals and private companies to be cautious in using these rapid test kits and asked doctors to help in testing and guide patients in the interpretation of the results.

Domingo also stressed the need for the DOH to increase the number of capable laboratories accredited to perform 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 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,” he said.