DOH: Only RT-PCR kits with 6 months shelf life were available in 2020

The Department of Health on Saturday said that only RT-PCR kits with a shelf life of six months were available in the market when the Procurement Service-Department Budget and Management (PS-DBM) procured the COVID-19 testing kits last year.

“As COVID-19 is a novel disease, the test kits used to detect the virus were only developed in the early months of 2020,” the DOH said in a statement.

“Back then, real-time RT-PCR test kits that were available in the market had a shelf life of only six months,” it added.

DOH's clarification came after Senator Francis Pangilinan questioned why certain RT-PCR kits procured by the PS-DBM did not meet the specifications set by the Health department. 

Pangilinan said that the DOH required a shelf life for the BGI real-time RT-PCR of 24 to 36 months from the date of delivery, but the inspection reports indicated that the expiry date of the procured kits delivered was just six months.

He pointed out that the items should have been rejected for not meeting the required specifications.

Former PS-DBM official Mervin Tanquintic, who was among the signatories of the documents in this purchase of test kits, said: "It was determined that kits would be consumed prior to the expiration date."

Tanquintic, however, admitted that these should have been rejected.

However, the DOH clarified that it did not disregard the six months shelf life of real-time RT-PCR test kits procured through the PS-DBM.

It explained that for the initial procurement of real-time RT-PCR testing kits early in the pandemic, the DOH through the Research Institute for Tropical Medicine (RITM) provided standard specifications of 12 to 24 months expiry for the real-time RT-PCR kits and 24 to 36 months shelf life for the extraction kits.

“These shelf life specifications were based on similar procurements prior to the pandemic,” the DOH said.

“This was due to manufacturers having no data on whether their test kits would be stable and useful beyond six months,” it noted.

The Health department said it acknowledged that the products have a short shelf life and accepted the deliveries even with the limitation.

It said that the deliveries of test kits were then requested on a staggered basis dependent on the consumption of the country.

“The COVID-19 RT-PCR test kits with six months shelf life are not near expiry, as that was the standard shelf life of those novel diagnostic test kits at the time,” said Atty. Charade Mercado-Grande, Undersecretary of the Health Regulation Team.

“Additionally, test kits are fast-moving stocks that have to be used immediately since we are in a pandemic. Our COVID-19 laboratories were able to test our kababayan using these procured test kits,” Mercado-Grande said.

During the Senate hearing on Friday, Health Secretary Francisco Duque III explained that there was a need for test kits during that period.

"Doon po sa inyong katanungan bakit tinanggap kahit hindi siya within the 24 to 36 months, at that time kasi very acute 'yung need for testing kits, hindi rin naman namin alam sa DOH na halos lahat pala ng testing kits na 'to talagang six months lang ang kanilang expiry period," Duque said.

(As for your query why we accepted the kits, there was an acute need during that time and we were unaware that all testing kits had a shelf life of just six months.)

But, Pangilinan said the test kits were purchased around April to May of last year and they were delivered around September.

Senators have been investigating the purchase of COVID-19 supplies last year, during which the questioned Pharmally Pharmaceutical Corporation bagged more than P8 billion in government contracts for the said procurement of personal protective equipment (PPEs), which were alleged to be overpriced.

Nonetheless, the DOH said that it only procured test kits that were on par with World Health Organization standards and passed RITM's evaluation. —LBG, GMA News