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Table 2
Performance comparison of the main methods and kits available for the detection of SARS Cov 2 by real-time RT-PCR.
| Reference | Method and designer | Principle of the method | Targeted genes | Performances | Converted LOD (copies/mL) | Analysis time | Official approval [9] |
|---|---|---|---|---|---|---|---|
| [54] | Charité − Universitätsmedizin Berlin Institute of Virology, Berlin, Germany and German Centre for Infection Research (DZIF), Berlin, Germany | Real-time RT-PCR: Detection of E gene and RdRP gene in confirmation, in two steps | E, RdRP | LOD for E gene: 3.9 copies/reaction LOD for RdRP gene: 3.6 copies/reaction | 156 copies/mL (E gene) 144 copies/mL (RdRP gene) | 3–4 h | Reference method, use for comparison |
| [55] | Centers for Disease Control and Prevention Division of Viral Diseases (USA) | Real-time RT-PCR Internal control by detection of P Rnase human gene) | N1, N2 | LOD : 1–3.2 copies/μL | 1000–3200 copies/mL | 3–4 h | Reference method, use for comparison |
| [51] | Simplexa ™ COVID-19 Direct (Italy) |
Multiplex real-time RT-PCR | S, ORF1ab | LOD: 3,2 (IC: 2,9–3,8) log10 cp/mL | 320 copies/mL | 1–2 h | under evaluation |
| [48] | Department of Microbiology, Chungbuk National University College of Medicine and Medical Research Institute, Cheongju, Replublic of Korea | reverse transcription-loop-mediated isothermal amplification (RT-LAMP) | N | LOD : 100 copies/réaction (Vf = 10 μL) | 10 000 copies /mL | 100 min | Korea Center for Disease Control |
| [56] | True Sample-To-Answer Solution ™ ePlexSARS-CoV-2 Cobas® 6800 et Cobas® 8800 (F. Hoffmann-La RocheAG) (Switzerland) |
Automated multiplex method: DNA hybridization by competition, electrochemical detection | N, E | LOD: 0,007 TCID50/mL | unavailable data | 3–4h | US FDA-EUA |
| [57] | BGI Biotechnology, Shenzhen, Chine) | Multiplex real-time RT-PCR | Highly conserved regions | LOD: 100 copies/mL | 100 copies/mL | 3–4h | China (NMPA) CE-IVD |
| [58] | Hangzhou Bigfish Bio-tech Co., Ltd., Zhejiang (Chine) |
Multiplex real-time RT-PCR | N, ORF1 ab | LOD < 200 copies /mL | 200 copies /mL | 3–4h | CE-IVD |
| [59] | Xpert® Xpress SARS-CoV-2 (Cepheid Inc.) (USA) |
Multiplex real-time RT-PCR | N2, E | LOD: 250 copies /mL | 250 copies /mL | 45 min | US FDA- EUA |
| [60] | Kit LightMix® E-gene (F. Hoffmann-La RocheAG) (Switzerland) |
simplex real time RT-PCR | E | LOD : 1,8.10−1 TCID 50/mL | Unavailable data | 66 min | limited to research applications |
| [61] | The Allplex™ 2019-nCoV assay (Seegene Inc., Seoul) (Korea) |
Multiplex real-time RT-PCR | E, N, RdRP | LOD: 100 copies / mL | LOD: 100 copies/mL | 3–4 h | Korea (Korea CDC) US FDA- EUA CE-IVD |
| [62] | TaqPath COVID-19 Combo Kit (Thermo Fisher Scientific) (USA) |
Multiplex real-time RT-PCR | ORF1ab, N, S | LOD : 10 copies / réactions (Vf=25 μL) | 400 copies/mL | 3–4 h | USA (EUA) |
| [63] | Novel Coronavirus (2019 nCoV) RT PCR (Dynamiker Biotechnology (Tianjin) Co., Ltd.) (China) |
Multiplex real-time RT-PCR | ORF1ab, N | LOD: 2 × 10^2 copies/mL | 200 copies/mL | 3–4 h | CE-IVD |
| [64] | BioFire® COVID-19 Test (BioFire Defense, LLC) (USA) |
Nested multiplexed real-time RT-PCR | ORF1ab, ORF8 | LOD: 2.2E-02 TCID50/mL | Unavailable data | 45 min | US FDA- EUA |
| [65] | ID NOW COVID-19 assay (Abbott) (USA) |
Simplex isothermal amplification | RdRP | LOD: 125 copies/mL | 125 copies/mL | <13 min | US FDA- EUA |
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