Table 2.
Commercial rRT-PCR test kits for diagnosing SARS-CoV-2 infection.
| Assay name | Company (country) | Targeted genes | Specimen types | TAT/test | Approval | Reference |
|---|---|---|---|---|---|---|
| Tests only for SARS-CoV-2 | ||||||
| Allplex™ 2019-nCoV Assay | Seegene (Korea) | RdRp, N, E | NPS, NPA, OPS, sputum, BAL | 3–4 h | Korea (Korea CDC) US FDA- EUA CE-IVD |
18 |
| LightMix® Modular Wuhan CoV RdRP-gene | Roche/Tib Molbiol (Switzerland/Germany) | RdRp | NPS, NPA TA, BAL | 3–4 h | No (RUO) | 19 |
| Cobas® SARS-CoV-2 Test | Roche (Switzerland) | ORF-1a, E | NPS, OPS | 3–4 h | US FDA- EUA CE-IVD |
21 |
| ePlex® SARS-CoV-2 Test | GenMark Diagnostics, (USA) | N, E | NPS | 3–4 h | USA (EUA) | 20 |
| TaqPath COVID-19 Combo Kit | Thermo Fisher Scientific (USA) | ORF-1ab, N, S | NPS, NPA, BAL | 3–4 h | USA (EUA) | 22 |
| Real-Time Fluorescent RT-PCR kit for detecting 2019-nCoV | BGI Biotechnology (China) | Highly conserved region of 2019-nCoV genome | NPS, serum, plasma | 3–4 h | China (NMPA) CE-IVD |
23 |
| SARS-CoV-2 Nucleic Acid Detection Kit (Fluorescence RT-PCR) | Hangzhou Bigfish Bio-tech, Co. Ltd. (China) | ORF-1ab, N | NPS, sputum, BAL | 3–4 h | CE-IVD | 25 |
| Novel Coronavirus (2019 nCoV) RT PCR | Dynamiker Biotechnology (Tianjin) Co., Ltd. (China) | ORF-1ab, N, actin | NPS, OPS, sputum, BAL, conjunctival swabs, serum, plasma, feces | 3–4 h | CE-IVD | 27 |
| ARGENE® SARS-COV-2 R-GENE® | bioMérieux (France) | RdRp, N, E | NPS | 3–4 h | No (RUO) | 26 |
| Xpert® Xpress SARS-CoV-2 | Cepheid (USA) | N2, E | NPS, nasal aspirate, nasal wash | 45 min | US FDA- EUA | 28 |
| BioFire® COVID-19 Test | BioFire Defense, LLC | ORF1ab, ORF8 | NPS | 45 min | US FDA- EUA | 29 |
| CRISPR–Cas12-based assay | Cepheid (USA) | N, E | NA | NA | NA | 31 |
| ID NOW COVID-19 assay | Abbott (USA) | RdRp | NPS, OPS, nasal wash directly or eluted in viral transport media | ≤13 min | US FDA- EUA | 32 |
| Included in syndromic diagnosis multiplex PCR panel | ||||||
| QIAstat-Dx® Respiratory 2019-nCoV Panel (22 targets) | QIAGEN (Netherlands) | RdRp, E | NPS | <70 min | US FDA- EUA CE-IVD |
40 |
| Biofire Filmarray RP-2.1 (22 targets) | bioMérieux (France) | RdRp, N, E | NPS | 60 min | No | 41 |
BAL, bronchoalveolar lavage; CE-IVD, Conformité Européenne in vitro diagnostic device; EUA, Emergency Use Authorization; KCDC, Korea Centers for Disease Control and Prevention; NA, not available; NMPA, National Medical Products Administration; NPA, nasopharyngeal aspirate; NPS, nasopharyngeal swab; OPS, oropharyngeal swab; RUO, research use only; TA, tracheal aspirates, US FDA, Food and Drug Administration of the United States.