The Research Institute for Tropical Medicine (RITM) clarified that it is not implementing a “pass or fail’ system in evaluating testing kits for coronavirus disease (COVID-19).
“Recent news stories are making the rounds claiming that RITM has publicly announced the evaluation results of STANDARD Q COVID-19 Antigen Test by SD Biosensor. No such announcement happened; as per our standard operating procedure, we forward detailed results of our evaluation activities to the Food and Drug Administration (FDA)—the duly recognized regulating body for food, drugs, cosmetics, and devices in the country—for their appropriate action,” RITM Director Celia Carlos said in a statement.
“The Institute does not implement a “pass or fail” system in evaluating kits. Its efforts are directed towards providing scientific expertise and technical evaluation to appropriate decision-makers, and not to prescribe specific commodities,” added Carlos.
Carlos stressed that RITM provides a summary of evaluation results for COVID-19 PCR, extraction, antigen, and antibody test kits through its official website after formal reports have been submitted to relevant agencies.
She explained that the summary is “meant to serve the continuous efforts of the Institute to maintain transparency amidst the pandemic.”
“The kit evaluation results from RITM is only one source of information. Decision-makers take into account all available data and technical input from other health authorities such as the World Health Organization (WHO),” said Carlos.
“RITM firmly maintained that its evaluation activities do not serve to endorse companies, manufacturers, distributors, or brands for commercial purposes,” she added.