Metro Manila (CNN Philippines, January 6) — Manufacturers of self-administered COVID-19 test kits may now register their products with the country’s Food and Drug Administration (FDA).
“As of today, we announced that we are accepting applications for special certification for COVID-19 self-administered or the home test kits,” FDA officer-in-charge Oscar Gutierrez said Thursday during a televised meeting with President Rodrigo Duterte and other officials leading the pandemic response.
Guidelines on the use of these test kits will be issued by the Department of Health (DOH) by Jan. 17, Gutierrez added.
He said these include rules on reporting and on waste disposal, and guidance on interpretation of test results, as well as on what actions must be taken by those found positive for the coronavirus.
According to Cabinet Secretary Karlo Nograles, both the FDA and the Department of Trade and Industry will actively call on manufacturers to apply for registration. He said the test kits that will receive certification should not only be accurate but also easy to use, considering it would be administered by the general public.
Some government officials, including testing czar Vince Dizon, have expressed openness to using at-home test kits as the country battles with a fresh surge of COVID-19 infections.
On Thursday, the DOH reported over 17,000 new cases – with the positivity rate jumping to a new record high of 36.9%. This means 1 in 3 people tested for coronavirus turned out infected. This percentage, considered “critical” by US nonprofit Covid Act Now, suggests insufficient testing and that there are likely more virus-hit individuals who have gone undetected.
Gutierrez said the FDA has so far approved a total of 89 brands of COVID-19 test kits — including 38 RT-PCR, 32 antigen, and 19 antibody test kits.
