Rapid testing kits approved by Philippine FDA

The use of five Rapid Test Kits for COVID-19 was approved on Monday by the Food and Drug Administration (FDA) in its efforts to support the pandemic, Director Gen. Undersecretary  Eric Domingo said.

Domingo said 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,”  Domingo said.

Domingo said 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 antibodies have not yet developed antibodies,” he said.

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 FDA official also said 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.

However, FDA called 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 (DOH) to increase the number of capable laboratories accredited to perform the PCR confirmatory tests.

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.

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,” said Domingo.

“Let us remain vigilant and hopeful as we protect each other’s welfare against those who seem to take advantage of this vulnerable situation,” he said.

“During this rapid increase of COVID-19 cases in the country, the agency continues to serve the people by giving access to testing without compromising our mandate of ensuring the safety, efficacy and quality of every health product for the public,” he further stated.

Meanwhile, Secretary Fortunato de la Peña announced on Monday that the public can expect the approval for the locally-made COVID-19 test kits this week.

“The field validation for the COVID-19 testing kits is ongoing and is expected to be finished by Wednesday, April 1,” he said.

The SARS-CoV-2 PCR Detection Kit, which is the first locally-made COVID-19 test kit, was developed by scientists from the University of the Philippines National Institute of Health (UP-NIH) and the Philippine Genome Center with the support of the Department of Science and Technology. It is being manufactured by Healthtek Inc.

The kit earlier received a Certificate of Exemption from the FDA so it can proceed with field testing.

De la Peña said the Certificate of Product Registration, which will allow its commercial sale, is expected on Friday, April 3.

“We have informed the FDA that requirements for CPR Certification will be submitted on Wednesday, April 1 at the latest,” said Dela Pena, adding that a  total of 120,000 test kits was already ordered for manufacturing.

“The company has also reported that the first batch of reagents arrived, which will enable them to start the manufacturing process,” De la Peña said.

He said an initial 26,000 test kits funded by the DOST and UP-NIH project will be used from April 4 to 25. He said these will be distributed to the Philippine General Hospital, Makati Medical Center, The Medical City, Vicente Sotto Memorial Medical Center, Southern Philippines Medical Center, and Baguio General Hospital.

“The remaining 94,000 testing kits will be sold commercially by Manila HealthTek at around P1,300 per kit which is cheaper than the units currently being used in hospitals which cost about P8,000,” De la Peña said.

The Manila HealthTek said they have enough orders from the private sector who intend to donate them in turn to the DOH and hospitals.

The SARS-CoV-2 PCR  Detection Kit is a real-time polymerase chain reaction (RT-PCR) based test kit. This is the same as the World Health Organization (WHO) test kits donated to the Philippine government.

PCR-based test kits can only be used in the laboratory.

The test itself lasts for a couple of hours but the whole process, including the transportation of samples, can last for 24 to 48 hours for patients expecting their test results.

The government is only approving the use of PCR-based test kits because of its accuracy as opposed to rapid test kits, which have been proven to be inaccurate./Stacy Ang