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RT-PCR test kits in 2020 have 6 months shelf-life: FDA

Food and Drug Administration Director General Eric Domingo said all reverse transcription-polymerase chain reaction (RT-PCR) test kits available in the market in 2020 have a shelf life of six months.

“Talaga pong six months lamang po ang available shelf-life ng RT-PCR test kits. At ito lang po ang mabibili ng DOH [Department of Health] at ng lahat po ng laboratory (The shelf-life of RT-PCR test kits was just six months. And these are the only kits the DOH and other laboratories can buy),” Domingo said during President Rodrigo Duterte’s Talk to the People on Wednesday night.

Domingo made the comment in reaction to reports that the DOH bought RT-PCR test kits that are “near expiry”.

Since the test kits were newly developed at the onset of the pandemic last year, Domingo said its shelf-life can only be determined through monitoring of its quality from the date it was manufactured.

“So, halimbawa po, ako ‘yung company na nagawa ng test kit. Kung gumawa ako sa kanya ng January, magtatabi po ako ngayon ng mga sample nito sa aking bodega at every month titingnan ko kung okay pa (for example, I’m the company manufacturing test kits. If I produced one in January, I will keep a sample in my warehouse and check it monthly if it’s still okay),” he said.

“So, hindi lang po sa DOH ‘yun. Lahat po ng private laboratory, lahat po ng RT-PCR laboratory, ang nabibiling test kit po noon ay six months lamang po ang (it’s not just with DOH. All private laboratories, all RT-PCR laboratories have bought kits with six months) shelf life,” Domingo said.

In response, Duterte thanked Domingo for explaining to the people the shelf-life of the RT-PCR test kits for Covid-19.

“So with that explanation, I’m glad that you are here tonight to really do the — to elaborate the things that have been — well, I would say sa news ng mga tao (news to the people),” Duterte said.

In a news release last Saturday, the DOH said it did not disregard the six months shelf life of RT-PCR test kits procured through the Procurement Service of the Department of Budget and Management.

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 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 Covid-19 is a novel disease, the test kits used to detect the virus were only developed in the early months of 2020.

Source: Philippines News Agency