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10.1016/j.jcv.2020.104573

http://scihub22266oqcxt.onion/10.1016/j.jcv.2020.104573
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suck abstract from ncbi


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pmid32769025      J+Clin+Virol 2020 ; 130 (ä): 104573
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  • Multicenter comparison of the Cobas 6800 system with the RealStar RT-PCR kit for the detection of SARS-CoV-2 #MMPMID32769025
  • Wirden M; Feghoul L; Bertine M; Nere ML; Le Hingrat Q; Abdi B; Boutolleau D; Ferre VM; Jary A; Delaugerre C; Marcelin AG; Descamps D; Legoff J; Visseaux B; Chaix ML
  • J Clin Virol 2020[Sep]; 130 (ä): 104573 PMID32769025show ga
  • 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(R) (Roche) and the RealStar(R) assay (Altona). METHODS: Assessment of the two assays was performed prospectively in three reference Parisians hospitals, using 170 clinical samples. They were tested with the Cobas(R) 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 (BioMerieux). 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(2)) of 0.88 and the Deming regression line revealed a strong correlation with a slope of 1.023 and an intercept of -3.9. Bland-Altman analysis showed that the mean difference (Cobas(R) minus RealStar(R)) was + 3.3 Ct, with a SD of + 2.3 Ct. CONCLUSIONS: In this comparison, both RealStar(R) and Cobas(R) 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(R) assay, probably due to a low viral load close to the detection limit of both assays.
  • |*Reverse Transcriptase Polymerase Chain Reaction[MESH]
  • |Betacoronavirus[MESH]
  • |COVID-19[MESH]
  • |COVID-19 Testing[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]
  • |Prospective Studies[MESH]
  • |Reagent Kits, Diagnostic[MESH]
  • |SARS-CoV-2[MESH]
  • |Sensitivity and Specificity[MESH]
  • |Viral Load[MESH]


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