Local test kits may be used if approved by FDA

THE locally developed test kits for Covid-19 may only be used after receiving a certificate of product registration (CPR) from the Food and Drug Administration (FDA), the Department of Health (DOH) said.

According to Health Undersecretary Maria Rosario Vergeire, the validation of test kits from the University of the Philippines National Institutes of Health (UP-NIH) is still ongoing.

“Ito pong test kits from UP NIH ay vina-validate pa rin po sa ngayon, ito pong proseso ng pag validate ay hindi po mabilis,” Vergeire said in a virtual press conference.

Vergeire said the kits are being tested through field trial.

“May pinipili po sila (FDA) na mga lugar para sa field trial, ito po ay para makita po natin na talagang epektibo ang mga test kits na ipapasok sa ating markets,” she said.

The undersecretary added that it takes at least two to three weeks to finish the validation process.

“Ang proseso po, noong nakausap namin sila, ay tatagal pa ng mga dalawa hanggang tatlong ligo—ito pong test kits na ‘to, pagka-tapos po ng field trial ay kailangan pa pong ma validate at mabigyan ng CPR mula sa FDA,” Vergeire explained.

“Ito po ay hindi puwedeng gamitin for commercial use, hanggat ‘di po na i-issuehan ng CPR ng FDA,” she said.

“Aantayin po natin na magkaroon sila ng cpr para magamit na po rito sa Pilipinas,” she added.

The FDA earlier issued a certificate of exemption for the detection kits, allowing its use for field testing coupled with gene sequencing at the Philippine Genome Center.

Philippine Genome Center deputy executive director Dr. Raul Destura said that the UP-NIH can produce as many as 6,000 diagnostic kits for Covid-19 in a span of three weeks. (SunStar Philippines)