Journal
JOURNAL OF CLINICAL VIROLOGY
Volume 129, Issue -, Pages -Publisher
ELSEVIER
DOI: 10.1016/j.jcv.2020.104520
Keywords
SARS-CoV-2; COVID-19; RT-PCR; Sensitivity
Categories
Funding
- Assistance Publique Hopitaux de Paris, the Universite de Paris
- ANRS (Agence Nationale de Recherche sur le SIDA et les hepatites virale) [AC43]
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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 RTPCR 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.
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