Antigen test kits (Photo courtesy of QC Government Facebook)
MANILA – The Food and Drug Administration (FDA) is in the final stages of evaluating applications for the approval of self-administered test kits while the Department of Health (DOH) is drafting the guidelines on how to properly use antigen test kits
DOH Undersecretary Maria Rosario Vergeire, in a television interview Saturday, said the FDA receives all the documents of the applicants and performs initial evaluation.
The results are then passed on to the Research Institute for Tropical Medicine (RITM) for performance validation.
Eleven manufacturers have applied for approval.
“Meron na pong sinasabi ang RITM na dalawang kit na finally na-validate at ipapasa na sa FDA ‘yan (RITM has already validated two [test kits] and [they] will be given back to FDA) for the final certification,” Vergeire said.
The process at the RITM takes four to five days, Vergeire said.
The DOH may issue the policy on the proper use of self-administered antigen test kits by next week.
“The reliability of antigen test kits would depend on their use. The most accurate result of an antigen test is if you use it at the right time,” Vergeire said.
Antigen test kits will be better used with the guidance of a health care worker to avoid a false negative result, according to experts.
Rapid antigen tests detect the presence of Covid-19 antigens, the substances that prompt the immune system to create antibodies.
Similar to home pregnancy tests, the thin line of the SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) test strip will change color if the sample taken from the nose or throat contains Covid-19 antigens.
Experts said antigen tests work best when someone is symptomatic while the risk of a false negative is much higher than a false positive, thus the need for a confirmatory test if the user wants to be absolutely sure.
During a Palace briefing on January 7, Vergeire said no self-administered antigen test kits have been registered with the FDA despite their proliferation online.
She said while self-test kits are easier to use, they require training to obtain a correct sample. (PNA)
