The Food and Drug Administration (FDA) has warned the public against the use of 10 antigen and rapid test kit brands for the detection of the virus that causes coronavirus disease (COVID-19).
In its Advisory No. 2021-2452, the FDA said these brands failed the “performance validation” conducted by the Research Institute for Tropical Medicine (RITM).
“The Food and Drug Administration (FDA) hereby provides the lists of companies with issued Special Certificate and failed performance validation conducted by the RITM as of 13 September 2021,” the agency stated in its advisory.
These test kits are: GenBody COVID-19 Ag sold by UC Biosciences Inc.; FaStep COVID-19 Antigen Rapid Test Device sold by Infinite Alliance Marketing Inc.; Gensure COVID-19 IgG/IgM Rapid Test sold by Nueva Sunshine Phils Inc.; SARS-CoV-2 IgG Screen sold by Kolonwel Trading; GA CoV-2 IgG/IgM sold by Khriz Pharma Trading Inc.; and COVID-19 Antigen Test Kit (Dry Fluorescence Immunoassay) sold by Eco Application Solutions.
Also included in the list were NADAL COVID-19 Ag Test sold by Diagnostika Pilipinas Inc.; SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) sold both by EHD Solutions Inc. and Touchstar Enterprises; and BD Veritor System for Rapid Detection of SARS-CoV-2 sold by Rebmann Inc.
FDA Center for Medical Devices Director Maria Cecilia Matienzo said that the “RITM is doing performance evaluation of the test kits.”
“Two parameters are tested, the sensitivity and specificity. Those test kits published with failed performance validation were not able to comply (with) the standard set either for sensitivity, specificity or both,” Matienzo said in a text message.