Recalled COVID-19 test kits from UP no longer available commercially, FDA assures

MANILA, Philippines — Test kits developed by the University of the Philippines – National Institutes for Health (UP-NIH) for coronavirus disease (COVID-19) are currently not available commercially following the discovery of a “minor defect” in the reagent used in the kits, the Food and Drug Administration on Thursday said Thursday.

FDA Director-General and DOH Undersecretary Eric Domingo confirmed that the test kits have been recalled by the manufacturer upon the UP-NIH’s submission for validation.

“Sa ngayon walang available commercially na PCR (polymerase chain reaction) kit,” Domingo said in an interview over Teleradyo.

(At the moment, UP test kits are not commercially available.)

Last April, the FDA approved the locally-made kits for commercial use after having them tested by the Philippine Genome Center.

However, upon undergoing validation from the Research Institute for Tropical Medicine (RITM), it was learned that 30% of the test kits yielded “indeterminate” results in finding out whether the specimen is positive or negative of the coronavirus.

Thus, 30% of the samples had to undergo a repeat test just to determine whether the coronavirus is present in the specimen or not.

“Accurate naman siya kaya lang mahirap siya gamitin kasi 30% inuulit mo (The kits are accurate, but it is hard to use when you have to retest 30% of the time),” Domingo said.

Upon further investigation, it was found out that the reagent used in the UP-developed test kits were “contaminated,” thus the manufacturer saw it fit to recall the kits as they order a new reagent.

“Nakita nila na ‘yung reagent na imported na ginagamit nila ay mukhang contaminated for the batch na ‘yun kaya bago magamit, ni-recall muna nila ‘yung existing na mga test kits at nag-order sila ngayon ng bagong reagent para magproduce ng bagong test kits,” Domingo added.

(They found out that the imported reagent being used for that batch of test kits were contaminated so they recalled the existing test kits and ordered a new reagent for the production of the new test kits.)

The kits have primarily been used by the UP Philippine General Hospital, one of the state-run hospitals in the frontline for COVID-19, but Domingo gave assurance that the samples used in the kits underwent confirmatory testing and genetic sequencing to ensure the accuracy of the results.

Once the UP-NIH is done developing a new batch of COVID-19 test kits, the FDA and the Department of Health will have it tested first before allowing it to be sold commercially, Domingo assured.

Health Undersecretary Maria Rosario Vergeire said the UP-NIH is now in the final stages of correcting the identified deficiency of the kits and it is eyeing to submit the new kits to RITM for validation.

This is the first locally made PCR-based COVID-19 test kit developed locally and approved by the FDA, and funded by the Department of Science and Technology (DOST).

The test kits cost about P1,250 each, which is still cheaper than the test kits bought internationally which cost about P6,000 on average, and which can yield results after two to three hours.

EDV