Table 2.
Commercially available diagnostics kits mainly used in Italy in real-time reverse transcription polymerase chain reaction (rRT-PCR) with gene target and limit of detection.
| Company (Assay Name) | Gene Target | LoD | Specimen Types | Approval |
|---|---|---|---|---|
| Abbott Diagnostics (ID NOW COVID-19) | RdRp | 125 copies/mL | Nasal, throat, NPS | FDA (US) |
| Abbott Molecular (Abbott RealTime SARS-CoV-2 EUA Test) | RdRp, N | 100 virus copies/mL | NPS, OPS, nasal swab, BAL | FDA (US) CE-IVD |
| Cepheid (Xpert Xpress SARS CoV-2) | N2, E | 250 copies/mL | NPS, OPS, nasal, mid-turbinate swab, nasal wash/aspirate | FDA (US), Health Canada, Australia, Singapore, Philippines, Brazil |
| DiaSorin Molecular (LIAISON MDX) | ORF1ab, S gene | NPS: 500 copies/mL, Nasal swab: 242 copies/mL | Nasal swab, NPS, nasal wash/aspirate, BAL | CE-IVD |
| Tib Molbiol (Modular DX kit SARS-CoV-2) | E | 1–10 copies/reaction | OPS, NPS | RUO (research use only) |
| Roche Molecular System (Cobas 6800 SARS-CoV-2) | ORF-1a/b, E | 1000 RNA genome equivalents/mL | NPS, OPS | US-FDA, CE-IVD |
| Seegene (Allplex 2019-nCoV Assay) | RdRp, N, E | 100 RNA copies/rxn | NPS, NPA, OPS, sputum, BAL | Korea (Korea CDC), US-FDA, CE-IVD |
| bioMerieux (ARGENE SARS-CoV-2 R-GENE) | RdRp, N, E | 380 genomic copies/mL | NPS | RUO (research use only) |
Legend: LoD: limit of detection, RnRp: RNA-dependent RNA polymerase, N: nucleocapsid, E: envelope, ORF: open reading frame, EUA: Emergency Use Authorization, BAL: bronchoalveolar lavage, NPA: nasopharyngeal aspirate, NPS: nasopharyngeal swab, OPS: oropharyngeal swab, FDA: Food and Drug Administration, CE-IVD: European Conformity In-Vitro Diagnostic, CDC: Centers for Disease Prevention and Control.