COVID-19

FDA to issue special certification for home test kits, DOH to issue guidelines

FDA to issue special certification for home test kits, DOH to issue guidelines

NEW POLICY. Home testing has been recommended by health experts as a way to help symptomatic persons check their COVID-19 status.

Photo by Charlie Villegas / OVP

The health department guidelines will include steps for people to report home test results and proper disposal of test kit parts
FDA to issue special certification for home test kits, DOH to issue guidelines

MANILA, Philippines – Amid a rise in COVID-19 cases and the stretching of the country’s testing capacity, the national government has decided to formalize a policy for the use of self-administered COVID-19 home test kits.

Food and Drug Administration officer-in-charge Oscar Gutierrez on Thursday, January 6, said the agency is accepting applications for Special Certification for COVID-19 home test kits starting that day.

He said this in a meeting with President Rodrigo Duterte in Malacañang. Gutierrez called on importers of eligible test kits to register their products with the FDA as home test kits.

The Department of Health is expected to release, by January 17, guidelines on the use of home test kits and how people who use them can formally report the results.

“We need guidelines on the use, reporting system, disposal of the waste, interpretation of the test results and what action should the individual take when he finds out he is positive,” said Gutierrez.

In a meeting last Tuesday, Dr. John Wong, who advises the national government on COVID-19 response, recommended home antigen test kits be made more widely available and affordable to the public.

In the Thursday meeting, Wong said that many transmissions are due to symptomatic individuals who, partly due to a lack of access to testing, decide to simply pursue their usual activities, thus spreading the virus to others.

The DOH has said that antigen tests are most useful for people with COVID-19 symptoms to find out if they are positive. An antigen test result that is positive is likely accurate in detecting COVID-19 but a negative test result often needs to be confirmed by an RT-PCR (reverse transcription polymerase chain reaction) test.

Why only now?

The government has started to move in earnest towards a formal policy on home testing nearly two years since the pandemic began. In contrast, many countries have long issued home testing policies and approved home test kits.

When asked why the government is doing this only now, Acting Presidential Spokesman and Cabinet Secretary Karlo Nograles said on Wednesday that it was a proposal that has always been considered by the government but that officials sought to prioritize RT-PCR testing.

“It’s something that we always consistently study, it’s always something that consistently on the table in the IATF (Inter-agency Task Force on Emerging Infectious Diseases). But we are always looking at the RT-PCR as a gold standard, remember,” he said.

The private sector has moved much faster in terms of home testing, with citizens able to purchase home test kits from pharmacies or medical practitioners. – Rappler.com

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