Two firms seek FDA nod for self-administered COVID-19 test kits
Two manufacturing companies applied for special certification for COVID-19 self-administered test kits, the Food and Drug Administration (FDA) said on Thursday.
"Two have already applied for our self-administered test kit, these are Clearbridge Medical Philippines, Inc. at MOHS Analytics, Inc.," FDA Officer-In-Charge Director Oscar Gutierrez, Jr. said during the ''Laging Handa'' virtual public briefing.
Gutierrez said the application of the two manufacturers were endorsed to the Research Institute for Tropical Medicine (RITM) last Monday.
"We expect the RITM to have their own requirements so we cannot predict how long they will do it, but once the FDA receives Validation Performance Report, within 48 hours the applicant can have their Special Certification," he said.
Gutierrez explained that the FDA only issues special certification if the test kits meet the 97 percent specificity and 80 percent sensitivity standards based on the performance validation report of the RITM.
He also emphasizes the importance of the guidelines that will be released by the Department of Health in the use of the COVID-19 self-administered test kits.
"The guidelines of the DOH are important. Because false negatives give false sense of security. While false positives provide unnecessary panic on the part of the patient. That is why it is important for us to follow the guidelines that will be issued by the DOH," he added. Robina Asido/DMS
