NextGen Day

The Food and Drug Administration (FDA) is examining applications for self-administered test kit approval, and the Department of Health (DOH) is creating instructions on how to utilize antigen test kits effectively.

In a television interview on Saturday, DOH Undersecretary Maria Rosario Vergeire said the FDA receives all of the applicants’ documentation and conducts the first examination.

After that, the results are sent to the Research Institute for Tropical Medicine (RITM) for performance validation.

Eleven companies have submitted applications for clearance.

“Meron na pong sinasabi ng RITM na dalawang kit na eventually na-validate at ipapasa na sa FDA’yan,” Vergeire remarked.

According to Vergeire, the RITM’s process takes four to five days.

By next week, the Department of Health could establish a policy on the proper use of self-administered antigen test kits.

“The use of antigen test kits will determine their reliability. “Using an antigen test at the correct moment yields the most accurate results,” Vergeire explained.

According to experts, antigen test kits will be better used with the assistance of a health care worker to avoid a false negative result.

Rapid antigen testing looks for Covid-19 antigens, which are the molecules that cause the immune system to produce antibodies.

The thin line on the SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) test strip will change color if the sample obtained from the nose or throat includes Covid-19 antigens, similar to home pregnancy tests.

Antigen testing functions best when someone is symptomatic, according to experts, and the danger of a false negative is significantly higher than the chance of a false positive, necessitating the use of a confirmatory test if the user wants to be certain.

Despite their widespread availability online, Vergeire claimed during a Palace briefing on January 7 that no self-administered antigen test kits have been registered with the FDA.

While self-test kits are simpler to use, she claims that they require training to collect a valid sample.

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