FDA WARNS VS 10 BRANDS OF ANTIGEN, RAPID TEST KITS

The public should be wary of certain brands of COVID-19 antigen and rapid test kits that failed to meet the standards of the Research Institute for Tropical Medicine (RITM).

The Food and Drug Administration (FDA) has recently advised the public against using these test kits: GenBody COVID-19 sold by UC Biosciences Inc.; FaStep COVID-19 Antigen Rapid Test Device sold by Infinite Alliance Marketing Inc.; COVID-19 Antigen Test Kit (Dry Fluorescence Immunoassay) sold by Eco Application Solutions; NADAL COVID-19 Ag Test sold by Diagnostika Pilipinas Inc.; SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) sold separately by EHD Solutions Inc. and Touchstar Enterprises; and BD Veritor System for Rapid Detection of SARS-CoV-2 sold by Rebmann Inc.It has also issued the

same notice for the following brands of rapid test kits: Gensure COVID-19 IgG/IgM sold by Nueva Sunshine Phils Inc., SARS-CoV-2 IgG Screen sold by Kolonwel Trading and GA CoV2 IgG/IgM sold by Khriz Pharma Trading Inc.

The test kits, all manufactured abroad, failed to comply with RITM’s standard for sensitivity and specificity, according to Maria Cecilia Matienzo, director of the FDA’s Center for Device Regulation, Radiation Health and Research.

“Two parameters are tested—sensitivity and specificity. Those test kits published with failed performance validation were not able to comply with the standard set for sensitivity, specificity or both,” Matienzo told the Inquirer.

RITM conducts evaluation of laboratory diagnostic tests such as the ones used in detecting COVID-19.

The agency has completed evaluation of 42 antibody test kits and 16 rapid antigen test kits as of Oct. 16, based on RITM data.

‘SOP’

In antigen rapid diagnostic tests (RDT), nasopharyngeal swabs are administered to determine whether a person is infected with SARS-COV-2, the virus that causes COVID-19, according to the World Health Organization.

In antibody RDT, blood samples are taken to show whether a person previously contracted the virus. But negative results from antibody tests do not mean that the individual is free from COVID-19.

Meanwhile, Trade Secretary Ramon Lopez said having antigen tests at home should now be considered standard operating procedure, citing the practice in the United Kingdom and the United States as example.

“What should be SOP for every person is to have an antigen test [that could be administered on his or her] own,” he told Radyo Pilipinas on Wednesday.

“We’ve observed in other countries—let’s say they’re reopening their economy and people are coming in and going out—what they did like in the UK and the US [was] they gave antigen tests to their citizens and then they are required to [get tested] twice a week or especially if they would go to a gathering.” he said.

FDA chief Eric Domingo had earlier sought the opinion of the Department of Health on the use of self-administered test kits, similar to what is being done in the United Kingdom and the United States. Health officials have yet to issue their opinion on the matter.

At present, the conduct of swab or antigen tests in the country is still limited to hospitals and designated centers.