TABLE 2.
Commercial rRT-PCR test kits for diagnosing SARS-CoV-2 infection.
| Assay name | Company (country) | Targeted genes | Sample type | Minimum detection limit | TAT/test | Approval | References |
| 2019-nCoV Nucleic acid detection kit (Fluorescence RT-PCR) |
Sansure Biotech Inc. (China) | ORF-1ab, N | Pharynx swab, bronchoalveolar lavage fluid | 200 copies/mL | 3–4 h | China (NMPA) | Sansure Biotech Inc, 2022 |
| SARS-CoV-2 Nucleic Acid Detection Kit (Fluorescence RT-PCR) |
ComWin Biotech Co., Ltd (China) | ORF-1ab, N, actin | Throat swab, nasal swab, nasopharyngeal extract, deep cough sputum | 1 × 103 copies/mL | 3–4 h | China (NMPA) | Cwbio, 2020 |
| 2019-nCoV Nucleic acid detection kit (Fluorescence RT-PCR) |
Shanghai GeneoDx Biotech Co., Ltd (China) | ORF-1ab, N | Nasopharyngeal swabs, sputum, bronchoalveolar lavage fluid | 500 copies/mL | ∼30 min | China (NMPA) | Wang X. et al., 2020 |
| Cobas® SARS-CoV-2 Test | Roche (Switzerland) | ORF-1a, E | Nasopharyngeal and oropharyngeal swabs | Target 1: 25 copies/mL (95% CI: 17wabslveolar la Target 2: 32 copies/ml (95% CI: 21–73 copies/mL) |
3–4 h | US FDA- EUA CE-IVD |
Staff, 2016 |
| ID NOW COVID-19 assay | Abbott (USA) | RdRp | Nasal, Throat, and Nasopharyngeal swabs | NA | ≤ 13 min | US FDA- EUA | Farfour et al., 2021 |
| CRISPR-Cas12-based assay | Cepheid (USA) | N, E | Respiratory swabs | NA | ≤ 40 min | NA | Broughton et al., 2020 |
| Biofire Filmarray RP-2.1 | bioMerieux (France) | RdRp, N, E | Nasopharyngeal swab in transport media or saline | NA | ∼45 min | No | BioFire, 2023 |
NMPA, National Medical Products Administration; CE-IVD, Conformite Europeenne in vitro diagnostic device; EUA, Emergency Use Authorization; US FDA, Food and Drug Administration of the United States; NA, not available.