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FDA says Covid-19 self-test kits could help reduce the necessity for swab tests

Once they receive regulatory approval and become widely available, self-administered Covid-19 test kits could help alleviate the excessive demand for swab testing, according to Food and Drug Administration (FDA) officer-in-charge Oscar Gutierrez.

Gutierrez stated in a televised public briefing that the Department of Health (DOH) would issue guidance on how to use the self-test kits properly so that people who have flu-like symptoms may be confident if they are infected with the coronavirus.

“At hindi na po sila pupunta sa mga testing center kung hindi naman kailangan, ayon sa guideline, hindi na rin sila pupunta sa mga ospital at ma-overwhelm po iyong mga healthcare workers natin (They no longer need to go to testing centers, ayon sa guideline, hindi n

On Monday, the FDA recommended that the Research Institute for Tropical Medicine (RITM) evaluate two self-administered test kits made by Clearbridge Medical Philippines, Inc. and MOHS Analytics, Inc.

In terms of detecting only the virus that causes Covid-19, the two standards utilized in evaluating the self-administered test kits are specificity (which must be 97 percent) and sensitivity (which must be 80 percent).

The FDA would assess the RITM’s Performance Validation Report for the kits within 48 hours and provide a special certification.

“Ang specific certification po ay puwede po siyang maging available po doon sa mga stores po ng mga producto na medical equipment,” Gutierrez explained.

“Doctor, magkakaroon po nitong tinatawag na prescription… The DOH will issue guidelines (There will be a doctor’s prescription [for the test kits]…the DOH will issue recommendations),” he added.

As the incidence of coronavirus illnesses rises, so does the demand for self-test kits, with the Philippines recording 34,021 new cases on January 13, the highest single-day total since March 2020.

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