Amid accusations favoring imported COVID-19 test kits, DOH lauds UP group making local kits

Kristine Sabillo, ABS-CBN News

Posted at Jul 21 2020 07:16 PM

MANILA — The Department of Health on Tuesday said it is fully supportive of Philippine-made COVID-19 test kits despite a delay in the roll-out of those made by University of the Philippines scientists.

“Kami po sa DOH katulong din po ang Department of Science and Technology PCHRD (Philippine Council for Health Research and Development) ay pinagmamalaki po ang ating homegrown scientists na patuloy na ginagamit ang kanilang talino at husay upang makatulong sa kapwa Pilipino sa buong mundo,” Health Undersecretary Maria Rosario Vergeire said during a televised briefing when asked about Surigao del Norte Rep. Robert Ace Barbers’ comments that the Health Secretary favored more expensive test kits from China.

Vergeire did not directly answer the accusation but she said that they “appreciate the Manila Healthtek team for their commitment to excellence and safety as they work closely with our independent laboratory expert panel in addressing key issues of version 1 of Genamplify.”

Manila Healthtek is the manufacturer of the UP-developed test kits. 

The health official explained that the government was already processing the application for the kits in April but that it was “voluntarily recalled by the Manila Healthtek after finding contamination in the probes and primers of their products.”

She then reiterated that the kits are now available for use.

“Pagkatapos po ng ilang buwang kolaborasyon kami po ay nagagalak na ibalita na ang Genamplify version 2, ang RT-PCR test kit ng ating bansa ay nabigyan na po ng special certification for commercial use ng FDA at papayagang na po nating gamitin under specific conditions,” Vergeire said.

(After months of collaboration, we are happy to announce that Genamplify version 2, our country’s RT-PCR test kit has already been given a special certification for commercial use by the FDA and it will be allowed to be used under specific conditions.)

There was a lot of excitement when UP announced in March that it was finalizing its development of a locally made COVID-19 test kit. This meant that the country would save time and money since the kits won’t be imported.

The kits, developed by the team of Dr. Raul Destura of the UP Philippine Genome Center, are supposed to be manufactured by local company HealthTek and will be initially bought by the DOST.

By April 3, the FDA approved the UP-developed Genamplify coronavirus disease-2019 rRT-PCR detection kit for commercial use. The DOST announced that of the initial batch of 120,000 test kits, 26,000 will be bought by the government and distributed to public laboratories.

However, when asked about the test kits, Vergeire on May 20 said that those had to be recalled because of a “minor” deficiency.

“During the time it was validated may nakitang konting problema yung testing kits based on the evaluation done by our national reference laboratory (RITM),” she said at the time.

(During the time it was validated they saw some problems with the testing kits based on the evaluation done by our national reference laboratory.)

Vergeire did not say the specific problem but said the team acknowledged it and is addressing it.

On July 10, Vergeire said the issue had already been resolved and that a letter has been sent to the DOST and the company manufacturing the test kits.

She said all that is left to do is for laboratories to receive instructions on how to use the test kits and for their personnel to undergo training.

The UP-developed test kits uses the same technology as the ones first given to the Philippines by the World Health Organization.

Like other PCR tests, it uses a reagent to isolate the genetic material from a patient’s sample. The kit also includes molecular grade water that serves as negative contorl and an amber-colored flourescent material that attaches itself to the COVID-19 virus. Unlike rapid antibody tests, such PCR tests are able to identify and measure if the patient actually has the COVID-19 virus.

Vergeire further explained on Tuesday that the DOH only wants to ensure that biosafety standards and procedures are followed to ensure the validity of the results and the safety of the lab personnel.