2020
DOI: 10.1007/s10096-020-03930-8
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The Allplex 2019-nCoV (Seegene) assay: which performances are for SARS-CoV-2 infection diagnosis?

Abstract: Several commercial assays for SARS-CoV-2 RT-PCR are available but few of them were assessed. We evaluate the Allplex 2019-nCoV (Seegene) assay using 41 nasopharyngeal samples. The rates of agreement were 92.7% and 100% with the GeneFinder COVID-19 plus (Elitech) and the diagnosis of the infectious disease specialist respectively. Four samples display a Ct < 22.0 for the E and RdRp genes while the N gene was not detected, suggesting a variabil… Show more

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Cited by 66 publications
(64 citation statements)
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“…Thus, based on the results of this study, we strongly recommend that rRT-PCR assays should validate more brands for RNA extraction kits to deal with the great demand of them for community screenings and possible future outbreaks. Although the Allplex 2019-nCoV assay failed to detect the N gene within the ssRNA, its performance was accurate for clinical samples, as previously reported ( Farfour et al, 2020 ). However, maximal caution is needed when detection of SARS-CoV-2 genes occurs at high Ct values, for which re-testing should be recommended.…”
Section: Discussionsupporting
confidence: 77%
“…Thus, based on the results of this study, we strongly recommend that rRT-PCR assays should validate more brands for RNA extraction kits to deal with the great demand of them for community screenings and possible future outbreaks. Although the Allplex 2019-nCoV assay failed to detect the N gene within the ssRNA, its performance was accurate for clinical samples, as previously reported ( Farfour et al, 2020 ). However, maximal caution is needed when detection of SARS-CoV-2 genes occurs at high Ct values, for which re-testing should be recommended.…”
Section: Discussionsupporting
confidence: 77%
“…Viral RNA from the upper respiratory tract swab samples was extracted using the MagNA Pure 96 System (Roche Diagnostics, Mannheim, Germany), according to the manufacturer's instructions. The resulting samples were tested for the E, RdRp and N genes of SARS-CoV-2 with real-time RT-PCR using theAllplex 2019-nCoV Assay kit (Seegene) 7 with CFX96 Real-Time PCR Detection System (Bio-Rad, Hercules, California, USA) under the following condition: 20 min at 50°C for reverse transcription and 15 min at 95°C for denaturation as the initial step, followed by 45 cycles of 15 s each at 94°C and 30 s at 58°C. A Ct value of <40 was used as the cut-off for determining positivity, according to the manufacturer's instructions.…”
Section: Rt-pcr For Sars-cov-2 Genesmentioning
confidence: 99%
“…Apart from the possibility to perform the RT-PCR in house using the selected primer pairs and probes, several ready to use kits were developed for RT-PCR performing. One of the most used is the Allplex 2019-nCoV (Seegene, Seoul, South Korea) which includes three different viral targets and a positive control [124]. Another example is represented by the BGI's real-time fluorescent RT-PCR Kit for detecting SARS-CoV-2 that includes one SARS-CoV-2 specific target and an internal control of the reaction (BGI, Cambridge, MA, USA).…”
Section: Nucleic Acid Detection Technologymentioning
confidence: 99%