The use of self-administered Covid-19 test kits could ease the high demand for swab testing once they get regulatory approval and become widely available, Food and Drug Administration (FDA) officer-in-charge Oscar Gutierrez said Thursday.
In a televised public briefing, Gutierrez said the Department of Health (DOH) would release guidelines on the proper use of the self-test kits so that persons experiencing flu-like symptoms could be sure whether 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, according to the guidelines, they don’t need to go to the hospital and our healthcare workers won’t be overwhelmed),” he said, noting that the DOH would know, based on available data, which community or population needs the kits.
On Monday, the FDA has endorsed two self-administered test kits manufactured by Clearbridge Medical Philippines, Inc. and MOHS Analytics, Inc. to the Research Institute for Tropical Medicine (RITM) for evaluation.
The two standards used in assessing the self-administered test kits are specificity (which must be 97 percent) and sensitivity (which must be 80 percent) in terms of identifying only the virus causing Covid-19.
Once the RITM issues a Performance Validation Report for the kits, the FDA would evaluate it within 48 hours and release a special certification.
“Ang special certification po ay puwede po siyang maging available po doon sa mga outlets po ng mga produkto na medical devices (With the special certification, the kits will be available in outlets of products with medical devices),” Gutierrez said.
“Magkakaroon po nitong tinatawag na prescription po ang doctor… may guidelines po ang DOH na ilalabas (There will be a doctor’s prescription [for the test kits]…the DOH will release guidelines),” he added.
The demand for self-test kits increases as the number of coronavirus infections further rise, with the Philippines logging 34,021 new infections on January 13, the single-day highest since March 2020.
Source: Philippines News Agency