Multicenter comparison of the Cobas 6800 system with the RealStar RT-PCR kit for the detection of SARS-CoV-2.
Betacoronavirus
COVID-19
COVID-19 Testing
Clinical Laboratory Techniques
/ methods
Coronavirus Infections
/ diagnosis
Humans
Limit of Detection
Molecular Diagnostic Techniques
/ methods
Pandemics
Pneumonia, Viral
/ diagnosis
Prospective Studies
Reagent Kits, Diagnostic
Reverse Transcriptase Polymerase Chain Reaction
SARS-CoV-2
Sensitivity and Specificity
Viral Load
Viral Proteins
/ genetics
Altona
COVID-19
Cobas 6800
RT-PCR
SARS-CoV-2
Journal
Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology
ISSN: 1873-5967
Titre abrégé: J Clin Virol
Pays: Netherlands
ID NLM: 9815671
Informations de publication
Date de publication:
Sep 2020
Sep 2020
Historique:
received:
13
07
2020
accepted:
29
07
2020
pubmed:
10
8
2020
medline:
6
10
2020
entrez:
10
8
2020
Statut:
ppublish
Résumé
RT-PCR testing is crucial in the diagnostic of SARS-CoV-2 infection. The use of reliable and comparable PCR assays is a cornerstone to allow use of different PCR assays depending on the local equipment. In this work, we provide a comparison of the Cobas® (Roche) and the RealStar® assay (Altona). Assessment of the two assays was performed prospectively in three reference Parisians hospitals, using 170 clinical samples. They were tested with the Cobas® assay, selected to obtain a distribution of cycle threshold (Ct) as large as possible, and tested with the RealStar assay with three largely available extraction platforms: QIAsymphony (Qiagen), MagNAPure (Roche) and NucliSENS-easyMag (BioMérieux). Overall, the agreement (positive for at least one gene) was 76 %. This rate differed considerably depending on the Cobas Ct values for gene E: below 35 (n = 91), the concordance was 99 %. Regarding the positive Ct values, linear regression analysis showed a coefficient of determination (R In this comparison, both RealStar® and Cobas® assays provided comparable qualitative results and a high correlation when both tests were positive. Discrepancies exist after 35 Ct and varied depending on the extraction system used for the RealStar® assay, probably due to a low viral load close to the detection limit of both assays.
Sections du résumé
BACKGROUND
BACKGROUND
RT-PCR testing is crucial in the diagnostic of SARS-CoV-2 infection. The use of reliable and comparable PCR assays is a cornerstone to allow use of different PCR assays depending on the local equipment. In this work, we provide a comparison of the Cobas® (Roche) and the RealStar® assay (Altona).
METHODS
METHODS
Assessment of the two assays was performed prospectively in three reference Parisians hospitals, using 170 clinical samples. They were tested with the Cobas® assay, selected to obtain a distribution of cycle threshold (Ct) as large as possible, and tested with the RealStar assay with three largely available extraction platforms: QIAsymphony (Qiagen), MagNAPure (Roche) and NucliSENS-easyMag (BioMérieux).
RESULTS
RESULTS
Overall, the agreement (positive for at least one gene) was 76 %. This rate differed considerably depending on the Cobas Ct values for gene E: below 35 (n = 91), the concordance was 99 %. Regarding the positive Ct values, linear regression analysis showed a coefficient of determination (R
CONCLUSIONS
CONCLUSIONS
In this comparison, both RealStar® and Cobas® assays provided comparable qualitative results and a high correlation when both tests were positive. Discrepancies exist after 35 Ct and varied depending on the extraction system used for the RealStar® assay, probably due to a low viral load close to the detection limit of both assays.
Identifiants
pubmed: 32769025
pii: S1386-6532(20)30315-2
doi: 10.1016/j.jcv.2020.104573
pmc: PMC7836314
pii:
doi:
Substances chimiques
Reagent Kits, Diagnostic
0
Viral Proteins
0
Types de publication
Comparative Study
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
104573Informations de copyright
Copyright © 2020 Elsevier B.V. All rights reserved.
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