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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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