DOH prepares to issue guidelines on self-administered antigen test

The Department of Health said Saturday it will be issuing the guidelines on how self-administered antigen test kits will be used while the Food and Drug Administration (FDA) is in the final stages of evaluating the registration of the products.

“We are drafting the guidelines on how this self-administered test kits will be used. The FDA is currently evaluating all of these 11 applications,” Health Undersecretary Maria Rosario Vergeire said in an interview on Dobol B TV.

Earlier, the DOH said 11 manufacturers of self-administered antigen test kits have applied to the FDA approval. 

“Nasa final stages na tayo ng evaluation ngayon. Meron na pong sinasabi ang RITM (Research Institute for Tropical Medicine) na dalawang kits na finally na-validate at ipapasa na sa FDA ‘yan for their final certification,” Vergeire said.

(We are now in the final stages of evaluation. RITM has already validated two and will be passed to the FDA for their final certification.)

Vergeire explained that once the FDA receives all the documents of the applicants, it will undergo an initial evaluation that will then be passed on to the RITM for performance validation.

“This takes four to five days with RITM and then will be returned to the FDA,” Vergeire said.

“So all in all the process can take up to seven days,” she added.

While waiting for the final FDA certification, the DOH official said the Health department will issue a policy “by next week” on how the self-administered antigen test kits can be used.

She clarified that use of self-administered antigen test kits currently available in the market need guidance from a healthcare worker and should not be used at home because wrong use can lead to a false negative result.

“The reliability of antigen test kits would depend on its use. The most accurate result of an antigen test if you use it at the right time and appropriate use,” she said.

“Ang reliability nito ay right time. Ginagamit lang ang atingen kung ang tao ay may sintomas and this is within the first five days of illness. Hindi basta-basta ginagamit ang antigen test. Ginagamit lang siya kapag may sintomas,” she added.

(It’s reliability relies on the right timing. Antigen tests can only be used if a person has symptoms, and this is within the first five days of illness. It should not be used carelessly, it should only be used if there are symptoms.) —LBG, GMA News