Metro Manila (CNN Philippines, April 21) —The Research Institute for Tropical Medicine in Muntinlupa City will begin evaluating the accuracy and effectivity of rapid antibody test kits for coronavirus disease.
Food and Drug Administration Director General Rolando Enrique Domingo shared the news in a statement on Tuesday.
Domingo then welcomed the development, saying “this will guide end users in selecting the kits they will use for testing.”
The official said in the past weeks, the RITM did not have the capacity to perform this function due to the high number of polymerase chain reaction-based tests it needed to process and because of its ‘lack of well-characterized serum samples needed to evaluate the rapid test kits.’
The FDA has not yet replied to CNN Philippines as to when the validation will start. RITM was forced to scale down its operations on April 18 after at least 40 of its employees contracted COVID-19. It is set to return to its normal operations by Saturday, the DOH said.
As of April 16, a total of 16 brands of rapid test kits have been approved for commercial use by the food and drug regulator.
All of the manufacturers of those kits were required to submit to RITM 300 pieces of their products, Domingo said.
“All future approvals of applications for special certification for COVID-19 shall be subject to performance validation as a post-marketing validation by RITM,” he added.
RITM is the national reference laboratory for emerging diseases.
The institute earlier served as the only confirmatory testing laboratory for COVID-19 in the Philippines. Now it is joined by 16 other coronavirus testing centers across the country.
Rapid tests give results in under an hour, while polymerase chain reaction-based tests may take 24 to 48 hours, sometimes longer due to backlogs.
However, the DOH and local infectious disease experts have cautioned against rapid antibody tests, saying they do not give definitive diagnosis. A PCR test is considered the “gold standard test.”
The health department has said rapid test results will still have to be validated using a PCR test afterwards.
