DOH denies Pharmally test kits purchased with six-month shelf life are nearing expiry

FILE PHOTO: A medical worker takes an oropharyngeal swab from a resident during mass testing for the COVID-19 coronavirus at a park in Quezon City, suburban Manila on April 15, 2020. (Photo by Ted ALJIBE / AFP)

MANILA, Philippines — Government-procured RT-PCR test kits for COVID-19 with six-month shelf life are not near expiry, the Department of Health (DOH) said Saturday amid a lawmaker’s observation that the kits purchased early in the pandemic did not meet required specifications for stock life.

In a statement, the health department said it “did not disregard” the six-month shelf life of RT-PCR test kits it purchased through the Procurement Service of the Department of Budget and Management (PS-DBM).

“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. 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 (countrymen) using these procured test kits,” said Atty. Charade Mercado-Grande, Undersecretary of the DOH’s Health Regulation Team.

The DOH issued the statement after Senator Francis Pangilinan noted that inspection reports signed by PS-DBM show that the purchased test kits only have a six-month shelf life despite the required specification that its stock life should have been at least 24 to 36 months from the date of delivery.

For the initial procurement of test kits early in the pandemic, the DOH, through the Research Institute for Tropical Medicine (RITM), provided that the shelf life should be 12 to 24 months for the RT-PCR kits and 24 to 36 months for the extraction kits. The DOH said these shelf life specifications were based on similar procurements prior to the pandemic.

However, the agency noted that since COVID-19 is a new disease, the test kits used to detect the SARS-CoV-2 virus that causes it were only developed in early 2020.

“Back then, real-time RT-PCR test kits that were available in the market had a shelf life of only six months. This was due to manufacturers having no data on whether their test kits would be stable and useful beyond six months,” it explained.

“The DOH acknowledged that these products have a short shelf-life and accepted the deliveries with this limitation. The deliveries of test kits were then requested on a staggered basis dependent on the consumption of the country,” it added.

The DOH assured that it only procured test kits at par with standards of the World Health Organization and that have passed RITM evaluation.

EDV