Comparison of seven commercial RT-PCR diagnostic kits for COVID-19
Data
2020Autor
Kasteren, Puck B. van
Veer, Bas van der
Brink, Sharon van den
Wijsman, Lisa
Jonge, Jørgen de
Brandt, Annemarie van den
Molenkamp, Richard
Reusken, Chantal B.E.M.
Meijer, Adam
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Resumo
The final months of 2019 witnessed the emergence of a novel coronavirus in the human population. Severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2) has since spread across the globe and is posing a major
burden on society. Measures taken to reduce its spread critically depend on timely and accurate identification of
virus-infected individuals by the most sensitive and specific method available, i.e. real-time reverse transcriptase
PCR (RT-PCR). Many commercial kits have recently become available, but their performance has not yet been
independently assessed.
The aim of this study was to compare basic analytical and clinical performance of selected RT-PCR kits from
seven different manufacturers (Altona Diagnostics, BGI, CerTest Biotec, KH Medical, PrimerDesign, R-Biopharm
AG, and Seegene).
We used serial dilutions of viral RNA to establish PCR efficiency and estimate the 95 % limit of detection
(LOD95). Furthermore, we ran a panel of SARS-CoV-2-positive clinical samples (n = 13) for a preliminary
evaluation of clinical sensitivity. Finally, we used clinical samples positive for non-coronavirus respiratory viral
infections (n = 6) and a panel of RNA from related human coronaviruses to evaluate assay specificity.
PCR efficiency was ≥96 % for all assays and the estimated LOD95 varied within a 6-fold range. Using clinical
samples, we observed some variations in detection rate between kits. Importantly, none of the assays showed
cross-reactivity with other respiratory (corona)viruses, except as expected for the SARS-CoV-1 E-gene.
We conclude that all RT-PCR kits assessed in this study may be used for routine diagnostics of COVID-19 in
patients by experienced molecular diagnostic laboratories.
Palabras clave
Coronavirus; In vitro diagnostics; nCoV-2019; COVID-19; SARS-CoV-2; RT-PCRLink para o recurso
https://doi.org/10.1016/j.jcv.2020.104412Collections
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