TABLE 1.
Some FDA approved diagnostic test kits for COVID‐19 infections
| Product | Manufacturers | Test type | Result time (h) | Approval status |
|---|---|---|---|---|
| Real‐time SARS‐COV‐2 | Abbott | PCR | 4–6 | FDA‐EUA |
| ID NOW COVID‐19 test | Abbott | Isothermal amp‐PoC | <1 | FDA‐EUA |
| AvellinoCoV2 | Avellino Labs | PCR | 24–48 | FDA‐EUA |
| BioGX SARS‐COV‐2 reagents | BioGX,BD | PCR | 2–3 | FDA‐EUA |
| Real‐time fluorescent RT‐PCR kit | BGI | PCR | 3 | FDA‐EUA |
| BIOFIRE COVID‐19 test | BioMerieux‐BioFire Defense | PCR | <1 | FDA‐EUA |
| 2019‐nCoV real‐time RT‐PCR Dx panel | CDC | PCR | 24–72 | FDA‐EUA |
| qSARS‐CoV‐2IgG/IgM rapid test kit | Cellex | Serological | <1 | FDA‐EUA |
| COVID‐19 ELISA IgG antibody test | Mount Sinai Laboratory | Serological | <1 | FDA‐EUA |
| DPP COVID‐19 IgM/IgG system | Chembio Diagnostic System, Inc | Serological | <1 | FDA‐EUA |
| VITROS immunodiagnostic products anti‐SARS‐COV‐2 total reagent pack | Ortho Clinical Diagnostic, Inc | Serological | <1 | FDA‐EUA |
| Xpert Xpress SARS‐COV‐2 test | Cepheid | PCR‐PoC | <1 | FDA‐EUA |
| Logix smart Coronavirus COVID‐19 test | Co‐Diagnostics | PCR | 1–2 | FDA‐EUA |
| Simplexa COVID‐19 direct | DiaSorin Molecular | PCR | 1 | FDA‐EUA |
| ePlex SARS‐COV‐2 test | GenMark Diagnostics | PCR | 2 | FDA‐EUA |
| COVID‐19 RT‐digital PCR detection kit | Gnomegen | PCR | 4–6 | FDA‐EUA |
| Panther fusion SARS‐COV‐2 Assay | Hologic | PCR | 3 | FDA‐EUA |
| Smart dectect SARS‐COV‐2rRT‐PCR kit | InBios International | PCR | 4–6 | FDA‐EUA |
| CoV‐19 IDx assay | Ipsum Diagnostics | PCR | 24 | FDA‐EUA |
| Covid‐19 RT‐PCR test | LabCorp | PCR | 24 | FDA‐EUA |
| ARISES SARS‐COV‐2 assay | Luminex Molecular Diagnostics | PCR | 2 | FDA‐EUA |
| NxTAG CoV extended panel assay | Luminex Molecular Diagnostics | PCR | 4 | FDA‐EUA |
| Accula SARS‐COV‐2 test | Mesa Biotech | PCR‐PoC | <1 | FDA‐EUA |
| SARS‐COV‐2 assay, 288/96 molecular system | NeuMoDx | PCR | 1–2 | FDA‐EUA |
| New coronavirus RT‐PCR test | Perkin Elmer | PCR | 4–6 | FDA‐EUA |
| COVID‐19 genesing real‐time PCR assay | Primerdesign | PCR | 2 | FDA‐EUA |
| QIAstat‐Dx respiratory SARS‐CoV‐2 panel | Qiagen (acq.by Thermo Fisher) | PCR | 96–120 | FDA‐EUA |
| Quest SARS‐COV‐2rRT‐PCR | Ouest | PCR | 1 | FDA‐EUA |
| Lyrra SARS‐COV‐2 assay | Quidel | PCR | 4–6 | FDA‐EUA |
| Cobas SARS‐COV‐2 test | Roche | PCR | 3–8 | FDA‐EUA |
| SARS‐COV‐2 RTqPCR detection kit | ScienceCell Research Labs | PCR | 4–6 | FDA‐EUA |
| TaqPath COVID‐19 combo kit | Thermo Fisher | PCR | 4 | FDA‐EUA |
| NY SARS‐COV‐2 real‐time RT‐PCR | Wadsworth Center,NY State Dept of Public Health | PCR | 24–72 | FDA‐EUA |
| SARS‐COV‐2 + influenza A & B RT‐qPCR kit | 3D Medicines | PCR | 4–6 | CE Mark |
| Real quality RQ‐2019‐nCoV | AB ANALITICA | PCR | 4–6 | CE Mark |
| Bosphore 2019‐nCoV detection kit | Anatolia Geneworks | PCR | 2 | CE Mark |
| SARS‐COV‐2, influenza, RSV panel | AusDiagnostics | PCR | 4–6 | CE Mark |
| AccuPower COVID 19 real‐time RT‐PCR kit | Bioneer | PCR | 8 | CE Mark |
| Q‐Sens 2019‐nCoV detection kit | Cancer Rop | PCR | 2 | CE Mark |
| VIASURE SARS‐COV‐2 real‐timePCR | CerTest Bioter,BD | PCR | 3 | CE Mark |
| VitaPCR SARS‐COV2 assay | Credo Diagnostics Biomedical | PCR‐PoC | <1 | CE Mark |
| QuantiVirus SARS‐COV‐2 test | DiaCarta | PCR | 2 | CE Mark |
| EasyScreen SARS‐COV‐2 Detection kit | Genetic Signature | PCR | 4–5 | CE Mark |
| Detection kit for SARS‐CoV‐2 | Genetic Health | PCR | 4 | CE Mark |
| qCOVID‐19, CLART COVID‐19 | Genomica /PharmMar Group | PCR | 5 | CE Mark |
| 2019 real‐time PCR Kit | Kogene Biotech | PCR | 4–6 | CE Mark |
| GeneFinder COVID‐19 RealAMp kit | OsangHealth | PCR | 4–6 | CE Mark |
| Allplex 2019‐nCoV assay | Seegene | PCR | 4 | CE Mark |
| DiaPlex Q 2019‐nCoV detection kit | SoIGent | PCR | 2 | CE Mark |
| SARS‐COV‐2 clinical sequence assay | Vision Medicals | NGS | >12 | CE Mark |
| Multiple real‐time PCR kit | Beijjing Applied Biological Technologies (XABT | PCR | 4–6 | CE Mark |
| SARS‐COV‐2RT‐PCR test | Children Hospital of Philadelphia (CHOP) | PCR | 4–6 | LDT (EUA) |
| MGH COVID‐19qPCR assay | Massachuesetts General Hospital | PCR | 4–6 | LDT (EUA) |
| SARS‐COV‐2 assay | Northwestern Medicine | PCR | 4–6 | LDT (EUA) |
| Viracor SARS‐COV‐2 assay | Viracor Eurofins Clinical Diagnostics | PCR | 4–6 | LDT (EUA) |
| Applied Biosystems TaqPath COVID‐19 combo kit | Rutgers Clinical Genomics Laboratory | PCR | 4–6 | LDT (EUA) |
| SDI SARS‐CoV‐2 assay | Special Diagnostic Laboratories | PCR | 4–6 | LDT (EUA) |
| UNC Health SARS‐COV‐2 real‐time RT‐PCR test | University of North Carolina | PCR | 4–6 | LDT (EUA) |
| Stanford SARS‐COV‐2 assay | Standard Health care | PCR | 4–6 | LDT (EUA) |
| Orig3n 2019 novel coronavirus (COVID‐19) test | Orig3n, Inc. | PCR | 4–6 | LDT (EUA) |
| SARS‐COV‐2 PCR test | Yale new Haven Hospital | PCR | 4–6 | LDT (EUA) |
| CDI enhanced COVID‐19 test | Hackensack University Medical Centre | PCR | 4–6 | LDT (EUA) |
| CirrusDx SARS‐COV‐2 assay | CirrusDx Laboratories | PCR | 4–6 | LDT (EUA) |
| Childrens‐Altona‐SARS‐COV‐2 assay | Infectious Diseases Diagnostics | PCR | 4–6 | LDT (EUA) |
| SARS‐COV‐2 test | Exact Sciences Laboratories | PCR | 4–6 | LDT (EUA) |
| SARS‐COV‐2 test | Integrity Laboratories | PCR | 4–6 | LDT (EUA) |
| COVID‐19 RT‐PC test | Medicine Lab of Baptist Hospital | PCR | 4–6 | LDT (EUA) |
| Explify respiratory | IDbyDNA | NGS | 24–48 | LDT |
| COVID‐19 home test kits | Carbon Health | PCR | 72–144 | Discontinued |
| At‐home Covid‐19 test | Everlywell | PCR | 48 | Discontinued |
| Covid‐19 home test kit | Nurx Molecular Testing Labs | PCR | 48 | Discontinued |
| GenBody COVID‐19 Ag | GenBody Inc | Lateral flow | <1 | EUA |
| QuickVue at‐home COVID‐19 Test | Quidel Corporation | Lateral flow | <1 | EUA |
| Flowflex COVID‐19 antigen home test | ACON Laboratories, Inc | Lateral flow | <1 | EUA |
| BinaxNOW COVID‐19 antigen self‐test | Abbott Diagnostics Scarborough, Inc | Lateral flow | <1 | EUA |
| BD veritor system | Becton, Dickinson and Company (BD) | Immunochromatographic | <1 | EUA |
| QIAreach SARS‐COV‐2 antigen test | QIAGEN GmbH | Lateral flow | <1 | EUA |
| LIAISON SARS‐CoV‐2 Ag | DiaSorin, Inc. | Immunochromatographic | <1 | EUA |
| CareStart COVID‐19 antigen | Access Bio, Inc | Lateral flow | <1 | EUA |
Note: Available on https://www.fda.gov/medical‐devices/emergency‐situations‐medical‐devices/emergency‐use‐authorizations, accessed on October 31, 2021.
Abbreviations: EUA, emergency use authorization; FDA, Food and Drug Authority; LDT, laboratory‐based test; NGS, next‐generation sequencing; PCR, polymerase chain reaction; PoC, Point‐of‐Care.