FDA receives 2 applications for self-administered antigen COVID-19 test kit

The Food and Drug Administration (FDA) said Thursday at least two companies manufacturing self-administered antigen COVID-19 test kit have applied for approval amid the surge of COVID-19 cases in the country.

Director Oscar Gutierrez, Jr., FDA officer-in-charge, identified the two companies as Clearbridge, Incorporated and MOHS Analytics, Incorporated.

"It should have 97% specificity and 80% sensitivity," Gutierrez said during the Laging Handa briefing.

"The RITM has set its requirements, so I cannot predict how long the application will be resolved," Gutierrez added.

He was referring to the Research Institute for Tropical Medicine.

"Once the FDA gets the validation performance report [from RITM], in 48 hours, we will decide if a special certification will be granted to the applicant," he added.

The demand for the self-administered antigen COVID-19 test kit increased following the spike in COVID-19 positivity rate in the country, resulting in laboratories getting swamped with specimens  of individuals who subjected themselves to an RT-PCR test due to COVID-19 symptoms or exposure to a COVID-19 case.

This development has resulted in a longer turnaround time for COVID-19 RT-PCR test results, prompting laboratories to set a cap on specimens to be processed each day at around 400.

The COVID-19 positivity rate in the country has soared to 45.7% from less than 1% just a month ago. — RSJ, GMA News