The Food and Drug Administration (FDA) has released the initial list of the approved test kits for Corona Virus Disease 2019 (COVID-19).
The four FDA-approved brands from China and South Korea are Nucleic acid detection kit for 2019 NCOV by Shanghai Genoe Dx Co., Novel Coronavirus 2019-ncov nucleic acid detection kit by Beijing Applied Biological Technologies Co. Ltd, Allplex TM 2019-nCoV Assay by Seegene Inc., and SOLGENT DialPlex Qtm Novel Coronavirus (2019-nCoV) detection kit by Solgent Co. Ltd.
According to FDA Director-General Eric Domingo, the test kits are PCR-based reagent kits that are specifically used in laboratories and not as home test kits.
The FDA is still waiting for the pending applications to go through evaluation.
The agency has also warned the public against unauthorized test kits for their safety.
Report from Mark Fetalco
