RATIONALE

The COVID-19 pandemic has ushered in the introduction of new laboratory diagnostic tests (PCR detection kits, antibody tests, antigen test). In accordance with DOH Department Order 2020-0820 “Institutionalizing and Strengthening the National Reference Laboratories in the Philippines,” the Research Institute for Tropical Medicine has been mandated to perform an evaluation of In-Vitro Diagnostic Medical Devices(IVDMDs) in collaboration with the FDA to ensure their quality and good performance in the local setting.

SCOPE/COVERAGE

These guidelines shall apply to all manufacturers, traders, suppliers, and distributors(importers/exporters/wholesalers) of PCR test kits, antibody, and antigen test kits, In-Vitro reagents, and other relevant supplies used to screen and confirm SARS-Cov-2 for the diagnosis of COVID-19(such as virus transport media, nasopharyngeal and oropharyngeal swabs)