FDA approval for locally-made COVID-19 test kits expected within the week

Kristine Sabillo, ABS-CBN News

Posted at Mar 30 2020 12:14 PM

MANILA — The Department of Science and Technology 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,” Science Secretary Fortunato de la Peña said in a statement.

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 Food and Drug Administration (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,” the Secretary said.

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 explained that an initial 26,000 test kits funded by the DOST and UP-NIH project will be used from April 4 to 25. 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 explained. 

“The Manila HealthTek said they have enough orders from the private sector who intend to donate them in turn to the Department of Health (Philippines) 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 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. 

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