Monday, October 11, 2021

Shelf-life requirements for test kits not disregarded

THE DEPARTMENT of Health (DOH) on Saturday clarified that it did not disregard the six months shelf life of SARS-CoV-2 real-time reverse transcription - polymerase chain reaction (RT-PCR) test kits procured through the Procurement Service of the Department of Budget and Management.  

In a news release, it said for the initial procurement of real-time RT-PCR testing kits early into the pandemic, the DOH through the Research Institute for Tropical Medicine (RITM) provided the following standard specifications – 12 months to 24 months expiry for the real-time RT-PCR kits and 24 months to 36 months shelf life for the extraction kits.

These shelf-life specifications were based on similar procurements before the pandemic, it added.

The DOH noted that as the coronavirus disease 2019 (Covid-19) is a novel disease, the test kits used to detect the virus were only developed in the early months of 2020.

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

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, depending 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. 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,” said Charade Mercado-Grande, undersecretary of the Health Regulation Team.

The DOH added that they only procured test kits that were at par with World Health Organization standards and passed RITM evaluation. 

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