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10.1016/j.jcv.2020.104520

http://scihub22266oqcxt.onion/10.1016/j.jcv.2020.104520
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suck abstract from ncbi


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pmid32652476      J+Clin+Virol 2020 ; 129 (ä): 104520
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  • Evaluation of the RealStar(R) SARS-CoV-2 RT-PCR kit RUO performances and limit of detection #MMPMID32652476
  • Visseaux B; Le Hingrat Q; Collin G; Ferre V; Storto A; Ichou H; Bouzid D; Poey N; de Montmollin E; Descamps D; Houhou-Fidouh N
  • J Clin Virol 2020[Aug]; 129 (ä): 104520 PMID32652476show ga
  • BACKGROUND: The use of efficient, reliable and sensitive PCR assays is a cornerstone in the race to contain the SARS-CoV-2 pandemic. In this work we performed an independent evaluation of the RealStar(R) SARS-CoV-2 RT-PCR Kit Researh Use Only (Altona) for SARS-CoV-2 detection. METHODS: A comparative limit of detection (LoD) assessment was performed between RealStar(R) SARS-CoV-2 and the currently WHO recommended RT-PCR (WHO-PCR) workflow using a quantified clinical sample. Assessment of the RealStar(R) SARS-CoV-2 assay was also performed using 83 primary clinical samples in comparison with the WHO-PCR. RESULTS: The RealStar(R) SARS-CoV-2 demonstrated a slightly higher sensitivity than the WHO recommended assay with a limit of detection at 625 copies/mL instead of 1250 copies/mL for the WHO-PCR in our conditions. The overall percent agreement between RealStar(R) SARS-CoV-2 and WHO-PCR on 83 clinical samples was 97.6 % (81/83) with a sensitivity at 97.8 % (45/46) and specificity at 97.3 % (36/37). No cross reaction was encountered for the other human coronaviruses (HKU1, OC43, NL63, 229E). CONCLUSIONS: In this comparison of the RealStar(R) SARS-CoV-2 assay with the reference WHO assay, we observed a slightly better sensitivity of the RealStar(R) assay. It provides a robust option for all molecular biology laboratories, with a strong real-life LoD and is compatible with various real-time PCR platforms.
  • |Betacoronavirus/*isolation & purification[MESH]
  • |COVID-19[MESH]
  • |COVID-19 Testing[MESH]
  • |COVID-19 Vaccines[MESH]
  • |Clinical Laboratory Techniques/*methods[MESH]
  • |Coronavirus Infections/*diagnosis[MESH]
  • |Humans[MESH]
  • |Limit of Detection[MESH]
  • |Molecular Diagnostic Techniques/*methods[MESH]
  • |Pandemics[MESH]
  • |Pneumonia, Viral/*diagnosis[MESH]
  • |Reverse Transcriptase Polymerase Chain Reaction/*methods[MESH]
  • |SARS-CoV-2[MESH]


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