By Alec Go
The Department of Health (DOH) will be issuing guidelines on the use of self-administered or home COVID-19 test kits once the kits have been approved by health authorities.
Food and Drug Administration (FDA) officer-in-charge Director Oscar Gutierrez said in the Thursday (Jan. 13) Laging Handa briefing that the guideline will include a monitoring system.
The guidelines on home test kits will not only provide steps on the proper conduct of tests, but also on the monitoring of their use, and for proper result interpretation.
“Importante ring malaman dito na kailangan may reporting system na magaganap, kasi mayroon pong aksiyon na dapat gawin ang isang mamamayan na gumamit nito, lalo na kung may lumabas na positive or negative, lalo na para sa mga pasyente na may sintomas,” he added.
The FDA has not yet approved any home COVID-19 test kit, but two applications for special certification have been submitted by Clearbridge Medical Philippines, Inc. and MOHS Analytics, Inc.
Gutierrez said their applications have been endorsed to the Research Institute for Tropical Medicine (RITM) last Monday (Jan. 10). There is no exact date yet for the issuance of their Special Certification.
“Once na natanggap ng FDA iyong tinatawag na Validation Performance Report, within 48 hours po mabibigyan po ng Special Certification iyong applicant,” he said.
The standard for the special certification requires that the kit’s specificity must be at 97% and its sensitivity at 80%. Evaluation will continue on the product even after it has been granted a certification.
The official said the approval of self-administered test kits and their availability in the market will ease the demand for swab testing, provided that DOH guidelines are followed.
“Mayroon pong konsultasyon na maaaring maganap na kapag gumamit tayo sa mga identified communities na kailangang mag-home test kit ang mga pasyente, kasama po nila ang DOH… Maaari pong maging teleconsultation,” he said.
In an Inter-Agency Task Force (IATF) meeting with President Rodrigo Duterte last week, the FDA said it has opened its door to applicants of home test kits. -rir
Watch the full interview here:
