By GABRIELA BARON
A medical group urged the Food and Drug Administration to revoke the certification of SD Biosensor antigen rapid diagnostic test after failing Department of Health and Research Institute of Tropical Medicine performance standards.
Some medical groups and private companies expressed r concern after DoH Undersecretary Rosario Vergeire revealed that a study conducted by the RITM showed that SD Biosensor 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 remained 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,” Dr. Michael Martin Lagman, who owns a diagnostic center that also conducts COVID-19 testing, said.
“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 prevalence of false positives,” he added.
SD Biosensor was the same antigen test that failed to meet the standards of the DoH during the pilot study in Baguio City in a bid to revive its tourism.
The DoH said they wanted at least 85 percent match. However, out of several brands of antigen kits being used to screen tourists entering Baguio City, only half of the antigen results showed accurate results when compared to the reverse transcription polymerase chain reaction result.
In a memorandum issued by FDA last Sept. 3, the regulatory body said they shall revoke certification of antigen tests which are not compliant with the standards according to the performance validation conducted by RITM.
The memorandum showed that COVID-19 antigen-based kits with special certification shall likewise undergo performance validation by the RITM as a part of FDA’s post marketing surveillance.
“FDA shall revoke 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 said.
“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,” it added.
However, FDA Director General Dr. Eric Domingo said that it has not revoked the approval of antigen rapid diagnostic test despite failing the DoH and RITM evaluation.
Domingo reiterated that RT-PCR techniques are still the gold standard for COVID-19 testing.
He added that antigen tests play an important role when used correctly because they can be done quicker with considerably less cost.
The DoH reminded that the use of antigen test for screening is still prohibited by the Health Technology Assessment Council.
