Table 2.
The table shows results of independent evaluation to verify the clinical performance of tests. The research was carried out at the University Hospitals of Geneva [12] (updated 13 June 2020, online sources).
| Developer | Name of the Kit | Gene | Clinical Sensitivity | Clinical Specificity | Limit of Detection LOD (Copies/Reaction) |
|---|---|---|---|---|---|
| altona Diagnostics | RealStar® SARS-CoV-2 RT-PCR Kit 1.0 | E | 92% | 100% | 1–10 |
| S | 92% | 100% | 1–10 | ||
| Atila BioSystems Inc. | Atila iAMP COVID-19 Detection (isothermal detection) | ORF1ab | 100% | 99% | 20–100 |
| N | 100% | 100% | 1–10 | ||
| BGI Health (HK) Co. Ltd. | Real-time Fluorescent RT-PCR kit for detection 2019-nCOV (CE-IVD) | ORF1 | 100% | 99% | 1–10 |
| bioMérieux | ARGENE® SARS-COV-2 R-GENE® | N | 100% | 100% | 10–50 |
| RdRP | 96% | 100% | 10–50 | ||
| BIONEER | AccuPower® SARS-CoV-2 Real-Time RT-PCR Kit | E | 100% | 100% | 10–50 |
| RdRP | 100% | 100% | 10–50 | ||
| Boditech Med. Inc. | ExAmplar COVID-19 real-time PCR kit (L) | E | 100% | 100% | 10–50 |
| RdRP | 90% | 100% | 50–100 | ||
| CerTest Biotec | VIASURE SARS-CoV-2 Real Time PCR Detection Kit | ORF1ab | 98% | 100% | 10–50 |
| N | 100% | 100% | 1–10 | ||
| DAAN Gene Co. Ltd. | Detection Kit for 2019 Novel Coronavirus (2019-nCoV) RNA (PCR-Fluorescence Probing) | ORF1 | 100% | 96% | 1–10 |
| N | 100% | 98% | 1–10 | ||
| EUROIMMUN | EURORealTime SARS-CoV-2 | ORF1ab/N | 100% | 98% | 1–10 |
| GeneFirst Ltd. | The Novel Coronavirus (2019-nCoV) Nucleic Acid Test Kit | ORF1 | 100% | 99% | 1–10 |
| N | 98% | 100% | 1–10 | ||
| KH Medical Co. Ltd. | RADI COVID-19 Detection Kit | S | 100% | 100% | 1–10 |
| RdRP | 100% | 100% | 10–50 | ||
| Primerdesign Ltd. | Coronavirus COVID-19 genesig® Real-Time PCR assay | RdRP | 100% | 100% | 1–10 |
| R-Biopharm AG | RIDA® GENE SARS-CoV-2 RUO | E | 100% | 100% | 1–10 |
| SD Biosensor Inc. | STANDARD M nCoV Real-Time Detection Kit | E | 100% | 97% | 1–10 |
| ORF1 | 100% | 99% | 1–10 | ||
| Seegene Inc. | Allplex™ 2019-nCoV Assay | E | 100% | 100% | 1–10 |
| N | 100% | 100% | 1–10 | ||
| RdRP | 100% | 100% | 1–10 | ||
| Shanghai Kehua Bio-Engineering | KHB Diagnostic kit for SARS-CoV-2 Nucleic Acid (Real-time PCR) | ORF1 | 100% | 100% | 1–10 |
| N | 100% | 100% | 1–10 | ||
| E | 100% | 100% | 1–10 | ||
| Tib Molbiol | ModularDx Kit SARS-CoV (COVID19) E-gene (Tib Molbiol) + LightCycler Multiplex RNA Virus Master (Roche) | E | 100% | 100% | 1–10 |
| Vela Diagnostics | ViroKey™ SARS-CoV-2 RT-PCR Test | RdRP | 94% | 100% | 10–50 |
| ORF1 | 100% | 100% | 1–10 |