A medical group insists the certification of SD Biosensor antigen rapid diagnostic test should be revoked by the Philippines’ Food and Drug Administration after failing Department of Health and Research Institute of Tropical Medicine performance standards
Some medical groups and private companies expressed concern after Health Undersecretary Rosario Vergeire said a study conducted by the RITM showed that SD Biosensor had only posted 71-percent sensitivity, which is below the sensitivity standard of the World Health Organization for diagnostic performance.
“We put the lives of each Filipino at risk if we continue to use this antigen test in our country. Its accuracy remains lacking and it can add up to the increasing number of COVID-19 cases in the Philippines, and we do not want that to happen,” said Michael Martin Lagman, a physician who owns a diagnostic center that also conducts COVID-19 testing.
“In this time of crisis, we believe that tests and treatments should be carefully assessed before routine use so as not to aggravate the dangers of the disease and the difficulties already faced by our healthcare system. We are deeply concerned about the high level of inaccuracies of the test, particularly the high prevalence of false positives.”
SD Biosensor was the same antigen test that failed to meet the standards of the Health department during the pilot study in Baguio City in a bid to revive its tourism. The department said it wanted at least an 85- percent match.
But out of several brands of antigen test kits being used to screen the tourists entering Baguio City, only half of the antigen results showed accurate results when compared to the PCR result.
In a memorandum issued by the FDA on Sept. 3, the regulatory body said it would revoke the certification of antigen tests that were not compliant with the standards according to the performance validation conducted by RITM.
The memorandum showed that COVID-19 Antigen-Based test kits with Special Certification would likewise undergo performance validation by the RITM as a part of the FDA’s post-marketing surveillance.
“FDA shall revoke the issued Special Certifications of antigen test kits which are not compliant with the standards according to the performance validation conducted by the RITM,” the memorandum says.
“Also, the FDA shall revoke the Special Certifications of companies which did not subject their antigen test kits for performance validation by RITM as required.”
However, FDA Director General Eric Domingo said they had not revoked the approval of the antigen rapid diagnostic test despite failing the Department of Health and RITM evaluation.
Domingo said RT-PCR techniques were still the gold standard for COVID-19 testing. He says antigen tests play an important role when used correctly because they can be done quicker with considerably less cost.
Meanwhile, the Department of Health said the use of antigen test for screening was still prohibited by the Health Technology Assessment Council.
