FDA OK’s Ph-made COVID-19 test kits

DOST Secretary Fortunato Dela Peña disclosed on Tuesday the distribution of locally made COVID-19 test kits in some hospitals has begun, following the approval of GenAmplify RT-PCR detection kit by the Food and Drug Administration (FDA).

The kits were developed by scientists from the UP National Institutions of Health, Philippine Genome Center, and Manila HealthTek Inc.
“Tuloy tuloy na ang commercial production at nagde-deliver na ang Manila Healthtek. According to our commitment from our DOST project, 26,000 tests na ibibigay sa mga designated hospitals na tatanggapin nito nang libre (The commercial production is ongoing and Manila HealthTek is now delivering. According to our commitment from our DOST project, 26,000 tests will be given to designated hospitals for free),” Dela Peῆa shared.

Each test kit costs Php 1,320 which is cheaper than its imported counterpart at Php 8,500. The FDA clarified it may be used by hospitals and laboratories at biosafety level 3. The results may be released in just 1 and a half hours.

The DOH said laboratory personnel who will use the said test kits must first undergo proficiency test to ensure accuracy of results. The kits were first approved by the FDA in April but minor defects were observed when it underwent validation under the RITM.
“‘Yung first kasing version, noong ginagamit na, nakita lang na mukhang may contamination ‘yung kanyang reagent kasi binibili ‘to galing sa ibang bansa. So noong na-localize naman nila ‘yung problema, ngayon iba na ang ginagamit nila na mga kasangkapan or reagents para dito (When the first version was being used, a contamination in its reagent was observed because it was bought abroad. But when the problem was localized, they are now using different reagents for it),” FDA Director General Eric Domingo explained.

Meanwihile, the Department of Health released the latest COVID-19 stats. As of July 21, the number of confirmed COVID-19 cases in the country reached 70,764. Recoveries rose to 23,281 while number of fatalities climbed to 1,837.

– Report from Mark Fetalco

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