MANILA, Philippines — The Research Institute for Tropical Medicine (RITM) can now evaluate the 16 antibody rapid test kits for the coronavirus disease 2019 (COVID-19) that was earlier approved by the Food and Drug Administration (FDA).
In a statement on Tuesday, FDA said RITM can now assess the test kits “in the interest of national emergency, health, and safety.”
“This is a welcome development, so that the reliability of the kits may be tested on local samples. This will guide end-users in selecting the kits they will use for testing,” FDA Director-General Rolando Domingo said.
RITM is supposed to perform the evaluation of the rapid test kits but it earlier did not have the capacity to do this due to the high volume of polymerase chain reaction (PCR) testing and the lack of well-characterized serum samples needed to evaluate the rapid test kits.
To date, FDA has approved 16 antibody rapid test kits for commercial use. These test kits have already completed the necessary documentary requirements and have undergone review and evaluation.
As part of post-marketing surveillance, the concerned stakeholders of the test kits were directed to submit samples to the RITM laboratory 30 days from receipt of the notice for performance evaluation.
“Recent news from other countries reporting poor performance of rapid antibody tests have cast doubts on the accuracy of some kits,” Domingo said.
“As the Philippines embarks on a mass testing strategy using both PCR based and Rapid Antibody test kits, validation of rapid kits by the RITM would be helpful in choosing the best products to use as we go forward now and after the end of the enhanced community quarantine,” he added.
COVID-19 is a respiratory ailment caused by the novel coronavirus or SARS-CoV-2, which outbreak started in China’s Wuhan City in Hubei province in late 2019.
For most people, the virus causes mild or moderate symptoms, such as fever and cough that clear up in two to three weeks. For some, especially older adults and people with existing health problems, it can cause more severe illness, including pneumonia, and death.