Experts said that antigen test kits will be better used with the guidance of a health care worker to prevent false negative result.
AS the Department of Health (DOH) is drafting the guidelines on how to properly use antigen test kits, the Food and Drug Administration (FDA) is in the final stages of evaluating applications for the approval of self-administered test kits.
In a television interview on Saturday, DOH Undersecretary Maria Rosario Vergeire stated that the FDA receives all the documents of the applicants and conducts initial assessment.
While self-test kits are more convenient to use, she explained that they require training to collect an accurate sample.
For performance validation, the results are then forwarded to the Research Institute for Tropical Medicine (RITM).
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.
According to Vergeire, the process at the RITM takes four to five days.
By next week, the DOH may issue the policy on the proper use of self-administered antigen test kits.
“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.
Experts said that antigen test kits will be better used with the guidance of a health care worker to prevent false negative result.
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.
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, according to experts.
Vergeire said during a Palace briefing on January 7 that no self-administered antigen test kits have been registered with the FDA despite their proliferation online.
