On 30 January 2020 the World Health Organization (WHO) declared Corona Virus Disease (COVID-19), caused by the SARS-CoV-2 virus, as a Public Health Emergency of International Concern (PHEIC). On March 11, WHO declared the COVID-19 a pandemic.
Early detection is essential in monitoring transmission intensity. Detection of SARS-CoV-2 RNA from patient’s samples has been recognized as the gold standard for diagnosing COVID-19. Other assays, which detect antibodies and antigens, were subsequently developed and introduced as adjuncts to PCR testing.
The Research Institute for Tropical Medicine (RITM), as the National Reference Laboratory, is mandated to perform the evaluation of commercially-manufactured in vitro diagnostic medical devices, in collaboration with the Philippine Food and Drug Administration (FDA).
In support of the national COVID-19 response, the Institute has undertaken evaluation of laboratory test kits (PCR, rapid antibody, rapid antigen kits), nucleic acid extraction kits, as well as virus transport media and swabs.
The Health Technology Assessment Council (HTAC)—as an independent advisory body with the overall role of providing guidance to the Department of Health (DOH) and the Philippine Health Insurance Corporation (PhilHealth) on the coverage of health interventions and technologies to be funded by the government—assigns the standard metrics by which these products are evaluated against.
Read more about the guidelines on the evaluation of in vitro diagnostic medical devices and other related laboratory diagnostic supplies for COVID-19 here.
Results of RITM evaluations do not, in any way or form, represent a Certificate of Product Registration or Certificate of Authorization issued by the Philippine Food and Drug Administration (FDA).
The Institute is making this information available for public good and does not serve to endorse companies, manufacturers, or product brands for commercial purposes.