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A European Multicentric Study on the analytical performance of DxN VERIS MDx system HBV assay
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Abstracts / Journal of Clinical Virology 70 (2015) S1–S126
Abstract No: 1539 Presentation at ESCV 2015: Poster 2 A European Multicentric Study on the analytical performance of DxN VERIS MDx system HBV assay Delgado 1 ,
Drago 2 ,
Fanti 2 ,
Fleury 3 ,
among the different sites make VERIS MDx HBV assay a helpful and reliable tool for HBV DNA viral load determination. http://dx.doi.org/10.1016/j.jcv.2015.07.200 Abstract No: 1540
R. M. D. H. M.R. Gismondo 5 , J. Izopet 4 , A. Lombardi 5 , M.A. Marcos 6 , D. Mileto 5 , K. Sauné 4 , P. Trimoulet 3 , J. Vila 6 , D. Whittaker 7
Presentation at ESCV 2015: Poster 2 A multicentric study on the analytical performance of the DxN Veris MDx System CMV assay
1 Microbiology Department, Hospital Universitario 12 de Octubre, Madrid, Spain 2 Clinical Chemistry and Microbiology laboratories, Niguarda Ca’ Granda Hospital, Milan, Italy 3 Virology Department, Hôpital Pellegrin, Bordeaux, France 4 Department of Virology, Federative Institute of Biology, CHU Toulouse, France 5 Virology Laboratory, Sacco Hospital, Milan, Italy 6 Department of Clinical Microbiology, Hospital Clinic, School of Medicine, University of Barcelona, Centre for International Health Research (CRESIB), Barcelona, Spain 7 Laboratory Medicine Building, NGH, Sheffield, United Kingdom
R. Delgado 1 , M. Drago 2 , D. Fanti 2 , H. Fleury 3 , J. Izopet 4 , M.A. Marcos 5 , C. Mengelle 4 , P. Trimoulet 3 , J. Vila 5 , D. Whittaker 6
Background: Beckman Coulter’s VERIS Molecular Diagnostic (MDx) system is a new fully automated system for quantitative and qualitative analysis of molecular targets. Seven European Virology Laboratories assessed theVERIS MDx HBV assay in order to determine its analytical performance. Methods: All sites followed the same protocol provided by Beckman Coulter. Precision was performed on 5 QC controls provided by Beckman Coulter, at different HBV DNA levels (1.4 log IU/ml; 3.3 log IU/ml; 5.9 log IU/ml; 8.8 log IU/ml), tested in duplicate for 20 days. Analytical specificity was assessed on 786 anti-HBc and HBV-DNA negative patient samples. The limit of detection was determined using serial dilutions of HBV WHO standard run in replicate of 12 per day for 3 days. Determination was performed using Probit transformation analysis. Method comparison between VERIS MDx HBV assay, and the Roche HBV assay and the Abbott HBV assay was determined at a total of 4 sites on 184 and 274 samples respectively. Results: For precision, the total standard deviation for all sites combined is ≤0.16 log IU/ml. The between site standard deviation and CV% are lower than 0.15 log IU/ml and 8% respectively. The overall analytical specificity is 100% (95% CI: 99.1–100%). Limit of detection for all sites combined is 3.43 IU/ml (3.18–3.67). Linearity is excellent in the range of 1.68–8.82 log IU/ml, with the following linear regression: y = 0.996x + 0.007 (r2 = 1). The correlation between VERIS versus Abbott and Roche is good. Passing-Bablok regression shows VERIS log IU/ml = −0.089 + 0.93 Abbott log IU/ml with bias of 0.215, 0.271 and 0.386 log IU/ml respectively for 25th, 50th, 75th percentiles. The Pearson correlation shows a good correlation between the two assays (Pearson r = 0.96, p < 0.001). Bland–Altman analysis on VERIS versus Abbott assay showed an overall bias of −0.381 log IU/ml with a standard deviation of 0.596. Similar analysis versus Roche HBV assay shows VERIS log IU/ml = −0.224 + 0.96 Roche log IU/ml with Passing-Bablock analysis, bias of −0.297, −0.322 and −0.366 log IU/ml respectively for 25th, 50th and 75th percentiles. The Pearson regression is r = 0.93. Bland–Altman shows an overall bias of −0.394 log IU/ml with a standard deviation at 0.557. Conclusion: VERIS MDx HBV assay shows good analytical performances at each of evaluation sites. The consistency of the results
1 Microbiology Department, Hospital Universitario 12 de Octubre, Madrid 28041, Spain 2 Clinical Chemistry and Microbiology laboratories, Niguarda Ca’ Granda Hospital, Milan, Italy 3 Virology Department, Hôpital Pellegrin, Bordeaux, France 4 Department of Virology, Federative Institute of Biology, CHU Toulouse, France 5 Department of Clinical Microbiology, Hospital Clinic, School of Medicine, University of Barcelona, Centre for International Health Research (CRESIB), Barcelona, Spain 6 Laboratory Medicine Building, North Lane, NGH, Sheffield, United Kingdom
Background: Beckman Coulter’s VERIS Molecular Diagnostic (MDx) System is a new fully automated system for quantitative and qualitative analysis of molecular targets. Six European Virology Laboratories assessed the VERIS MDx CMV assay in order to determine its analytical performance. Methods: All sites followed the same protocol provided by Beckman Coulter. Precision was performed on 5 QC controls provided by Beckman Coulter, at different CMV DNA levels (6.9 log IU/ml; 5.6 log IU/ml; 4.6 log IU/ml; 3.7 log IU/ml; 2.5 log IU/ml), tested in duplicate for 20 days. Analytical specificity was assessed on 852 anti-CMV and CMV-DNA negative patient samples. The limit of detection was determined using serial dilutions of CMV WHO standard run in replicates of 12 per day for 3 days using Probit transformation analysis. Method comparison between VERIS MDx CMV assay and Roche COBAS® AmpliprepTM /COBAS® Taqman CMV assay was analyzed using Passing-Bablok linear regression on 180 patient samples from 2 sites. Bland–Altman for overall bias and Pearson Correlation was also performed on positive samples. Results: For precision, the total standard deviation for all sites combined is ≤0.17 log IU/ml. The between site standard deviation and CV% are lower than 0.05 log IU/ml and 0.85% respectively. The overall analytical specificity is 99.6% (95% CI: 99.0–99.9%). Limit of detection for all sites combined is 13.9 IU/ml (12.5–15.3 IU/ml). Linearity performance is excellent and consistent among the 6 sites; regression analysis gave y = 0.973x + 0.892 with r2 = 1, within the range 2.86–5.79 log IU/ml. The Passing-Bablok regression shows VERIS log IU/ml = 0.706 + 0.86.Roche log IU/ml with bias of 0.271, 0.204 and 0.123 log IU/ml respectively for 25th, 50th, 75th percentiles. The Pearson correlation shows a good correlation between the two assays (Pearson r = 0.87, p < 0.001). A Bland–Altman analysis on VERIS MDx CMV assay versus Roche COBAS® AmpliprepTM /COBAS® Taqman CMV assay showed an overall bias of 0.196 log IU/ml with a standard deviation of 0.501. Conclusion: The VERIS MDx CMV assay shows good analytical performances at each of evaluation sites. The consistency of the
Abstracts / Journal of Clinical Virology 70 (2015) S1–S126
Abstract No: 1539 Presentation at ESCV 2015: Poster 2 A European Multicentric Study on the analytical performance of DxN VERIS MDx system HBV assay Delgado 1 ,
Drago 2 ,
Fanti 2 ,
Fleury 3 ,
among the different sites make VERIS MDx HBV assay a helpful and reliable tool for HBV DNA viral load determination. http://dx.doi.org/10.1016/j.jcv.2015.07.200 Abstract No: 1540
R. M. D. H. M.R. Gismondo 5 , J. Izopet 4 , A. Lombardi 5 , M.A. Marcos 6 , D. Mileto 5 , K. Sauné 4 , P. Trimoulet 3 , J. Vila 6 , D. Whittaker 7
Presentation at ESCV 2015: Poster 2 A multicentric study on the analytical performance of the DxN Veris MDx System CMV assay
1 Microbiology Department, Hospital Universitario 12 de Octubre, Madrid, Spain 2 Clinical Chemistry and Microbiology laboratories, Niguarda Ca’ Granda Hospital, Milan, Italy 3 Virology Department, Hôpital Pellegrin, Bordeaux, France 4 Department of Virology, Federative Institute of Biology, CHU Toulouse, France 5 Virology Laboratory, Sacco Hospital, Milan, Italy 6 Department of Clinical Microbiology, Hospital Clinic, School of Medicine, University of Barcelona, Centre for International Health Research (CRESIB), Barcelona, Spain 7 Laboratory Medicine Building, NGH, Sheffield, United Kingdom
R. Delgado 1 , M. Drago 2 , D. Fanti 2 , H. Fleury 3 , J. Izopet 4 , M.A. Marcos 5 , C. Mengelle 4 , P. Trimoulet 3 , J. Vila 5 , D. Whittaker 6
Background: Beckman Coulter’s VERIS Molecular Diagnostic (MDx) system is a new fully automated system for quantitative and qualitative analysis of molecular targets. Seven European Virology Laboratories assessed theVERIS MDx HBV assay in order to determine its analytical performance. Methods: All sites followed the same protocol provided by Beckman Coulter. Precision was performed on 5 QC controls provided by Beckman Coulter, at different HBV DNA levels (1.4 log IU/ml; 3.3 log IU/ml; 5.9 log IU/ml; 8.8 log IU/ml), tested in duplicate for 20 days. Analytical specificity was assessed on 786 anti-HBc and HBV-DNA negative patient samples. The limit of detection was determined using serial dilutions of HBV WHO standard run in replicate of 12 per day for 3 days. Determination was performed using Probit transformation analysis. Method comparison between VERIS MDx HBV assay, and the Roche HBV assay and the Abbott HBV assay was determined at a total of 4 sites on 184 and 274 samples respectively. Results: For precision, the total standard deviation for all sites combined is ≤0.16 log IU/ml. The between site standard deviation and CV% are lower than 0.15 log IU/ml and 8% respectively. The overall analytical specificity is 100% (95% CI: 99.1–100%). Limit of detection for all sites combined is 3.43 IU/ml (3.18–3.67). Linearity is excellent in the range of 1.68–8.82 log IU/ml, with the following linear regression: y = 0.996x + 0.007 (r2 = 1). The correlation between VERIS versus Abbott and Roche is good. Passing-Bablok regression shows VERIS log IU/ml = −0.089 + 0.93 Abbott log IU/ml with bias of 0.215, 0.271 and 0.386 log IU/ml respectively for 25th, 50th, 75th percentiles. The Pearson correlation shows a good correlation between the two assays (Pearson r = 0.96, p < 0.001). Bland–Altman analysis on VERIS versus Abbott assay showed an overall bias of −0.381 log IU/ml with a standard deviation of 0.596. Similar analysis versus Roche HBV assay shows VERIS log IU/ml = −0.224 + 0.96 Roche log IU/ml with Passing-Bablock analysis, bias of −0.297, −0.322 and −0.366 log IU/ml respectively for 25th, 50th and 75th percentiles. The Pearson regression is r = 0.93. Bland–Altman shows an overall bias of −0.394 log IU/ml with a standard deviation at 0.557. Conclusion: VERIS MDx HBV assay shows good analytical performances at each of evaluation sites. The consistency of the results
1 Microbiology Department, Hospital Universitario 12 de Octubre, Madrid 28041, Spain 2 Clinical Chemistry and Microbiology laboratories, Niguarda Ca’ Granda Hospital, Milan, Italy 3 Virology Department, Hôpital Pellegrin, Bordeaux, France 4 Department of Virology, Federative Institute of Biology, CHU Toulouse, France 5 Department of Clinical Microbiology, Hospital Clinic, School of Medicine, University of Barcelona, Centre for International Health Research (CRESIB), Barcelona, Spain 6 Laboratory Medicine Building, North Lane, NGH, Sheffield, United Kingdom
Background: Beckman Coulter’s VERIS Molecular Diagnostic (MDx) System is a new fully automated system for quantitative and qualitative analysis of molecular targets. Six European Virology Laboratories assessed the VERIS MDx CMV assay in order to determine its analytical performance. Methods: All sites followed the same protocol provided by Beckman Coulter. Precision was performed on 5 QC controls provided by Beckman Coulter, at different CMV DNA levels (6.9 log IU/ml; 5.6 log IU/ml; 4.6 log IU/ml; 3.7 log IU/ml; 2.5 log IU/ml), tested in duplicate for 20 days. Analytical specificity was assessed on 852 anti-CMV and CMV-DNA negative patient samples. The limit of detection was determined using serial dilutions of CMV WHO standard run in replicates of 12 per day for 3 days using Probit transformation analysis. Method comparison between VERIS MDx CMV assay and Roche COBAS® AmpliprepTM /COBAS® Taqman CMV assay was analyzed using Passing-Bablok linear regression on 180 patient samples from 2 sites. Bland–Altman for overall bias and Pearson Correlation was also performed on positive samples. Results: For precision, the total standard deviation for all sites combined is ≤0.17 log IU/ml. The between site standard deviation and CV% are lower than 0.05 log IU/ml and 0.85% respectively. The overall analytical specificity is 99.6% (95% CI: 99.0–99.9%). Limit of detection for all sites combined is 13.9 IU/ml (12.5–15.3 IU/ml). Linearity performance is excellent and consistent among the 6 sites; regression analysis gave y = 0.973x + 0.892 with r2 = 1, within the range 2.86–5.79 log IU/ml. The Passing-Bablok regression shows VERIS log IU/ml = 0.706 + 0.86.Roche log IU/ml with bias of 0.271, 0.204 and 0.123 log IU/ml respectively for 25th, 50th, 75th percentiles. The Pearson correlation shows a good correlation between the two assays (Pearson r = 0.87, p < 0.001). A Bland–Altman analysis on VERIS MDx CMV assay versus Roche COBAS® AmpliprepTM /COBAS® Taqman CMV assay showed an overall bias of 0.196 log IU/ml with a standard deviation of 0.501. Conclusion: The VERIS MDx CMV assay shows good analytical performances at each of evaluation sites. The consistency of the