The Food and Drug Administration (FDA) approved the first four test kits to detect SARS-CoV-2, the virus that causes the pneumonia-like disease COVID-19.
In a statement, the FDA stated that “these are PCR (polymerase chain reaction)-based reagent kits used in laboratories and not point-of-care or do-it-yourself kits.”
The FDA is under the Department of Health (DOH).
The approved COVID-19 test kits for commercial use are:
- Nucleic acid detection kit, manufactured by Shanghai GenoeDx Biotech Co. Ltd.-Shanghai, China. It is distributed by S&S Enterprise.
- Novel coronavirus 2019 nucleic acid detection kit (fluorescence PCR method), manufactured by Beijing Applied Biological Technologies Co. Ltd. It is distributed by Sahar International.
- AllplexTM 2019-nCoV Assay, manufactured by Seegene Inc. – Seoul, South Korea. It is distributed by Endure Medical Inc.
- SOLGENT DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit, manufactured by Solgent Co. Ltd – 3F, 32, Techno 6-ro, Yuseong-gu, Daejeon, South Korea. It is distributed by Wellness Pro Inc.
The initial list of approved kits would be regularly updated.