Ex-DOH chief Garin warns vs. use of UP-developed testing kits sans FDA evaluation

Former Health Secretary and now House Deputy Minority Leader Janette Garin has cautioned the Department of Health (DOH) against the mass purchase of testing kits for COVID-19 that was developed by scientists from the University of the Philippines (UP) pending further findings on its merits.

Garin made the call as the Food and Drug Administration (FDA) issued a Certificate of Exemption for the SARS CoV-2 PCR Detection Kit of the UP-National Institute of Health (UP-NIH).

As a result, the said test kit will be used for “field testing coupled with gene sequencing at the Philippine Genome Center.”

“Nakakatakot ang desisyon ng FDA na mag-issue ng certificate of exemption rito kasi FDA is the lone agency which can certify the safety and efficiency of medicines, vaccines and devices sa ating bansa. Kung gagastusan natin ang testing kit na hindi pa dumadaan sa proseso para matiyak ang accuracy, specificity and sensitivity of the kit and given the minimal samples, baka maraming mag-false negative o false positive,” Garin said.

“This could cause confusion kasi puedeng maraming mag-isip na negative sila [sa COVID-19] pero positive pala, at mayroon ring mag-aalala na positive sila eh iyon pala ay negative naman sila,” Garin added.

Garin said that while Health Secretary Francisco Duque III has already been informed verbally by Director General Eric Domingo of the FDA that the UP-developed testing kits are 95 percent accurate, the threshold set by the World Health Organization (WHO), the Health chief also admitted that he is yet to see for himself pertinent documents which would prove that claim.

Likewise, Garin cited that even the WHO admitted during DOH’s briefing at the House on Wednesday that it is yet to evaluate the new testing kit.

“It was a verbal communication relayed to Secretary Duque, and the WHO also said that they are yet to look into it. I am in support of our scientists, pero para masabi na puede ng gamitin at i-mass produce, it should have the accuracy, specificity and sensitivity of those kits being supplied by the WHO to us for free,” Garin added.

Garin said that local government units should instead promptly administer anti-flu and anti-pneumonia shots to senior citizens as provided by law since the elderly are the ones vulnerable to COVID-19 infection. —LDF, GMA News