TY - JOUR
T1 - Nation-wide measure of variability in HCMV, EBV and BKV DNA quantification among centers involved in monitoring transplanted patients
AU - Abbate, Isabella
AU - Piralla, Antonio
AU - Calvario, Agata
AU - Callegaro, Anna Paola
AU - Giraldi, Cristina
AU - Lunghi, Giovanna
AU - Gennari, W.
AU - Sodano, Giuseppe
AU - Ravanini, Paolo
AU - Conaldi, Pier Giulio
AU - Vatteroni, Maria Linda
AU - Gaeta, Aurelia
AU - Paba, Pierpaolo
AU - Cavallo, Rossana
AU - Baldanti, Fausto
AU - Lazzarotto, Tiziana
PY - 2016/9/1
Y1 - 2016/9/1
N2 - Background Inter-laboratory variability in quantifying pathogens involved in viral disease following transplantation may have a great impact on patient care, especially when pre-emptive strategies are used for prevention. Objectives The aim of this study was to analyze the variability in quantifying CMV, EBV and BKV DNA from 15 virology laboratories of the Italian Infections in Transplant Working Group (GLaIT) involved in monitoring transplanted patients. Study design Panels from international Quality Control programs for Molecular Diagnostics (QCMD, year 2012), specific for the detection of CMV in plasma, CMV in whole blood (WB), EBV and BKV were used. Intra- and inter-laboratory variability, as well as, deviations from QCMD consensus values were measured. Results 100% specificity was obtained with all panels. A sensitivity of 100% was achieved for EBV and BKV evaluations. Three CMV samples, with concentrations below 3 log10 copies/ml, were not detected by a few centers. Mean intra-laboratory variability (% CV) was 1.6 for CMV plasma and 3.0 for CMV WB. Mean inter-laboratory variability (% CV) was below 15% for all of the tested panels. Inter-laboratory variability was higher for CMV in WB with respect to the CMV plasma panel (3.0 vs 1.6% CV). The percentiles 87.7%, 58.6%, 89.6% and 74.7% fell within ± 0.5 log10 difference of the consensus values for CMV plasma, CMV WB, EBV and BKV panels, respectively. Conclusions An acceptable intra- and inter-laboratory variability, in comparison with international standards was observed in this study. However, further harmonization in viral genome quantification is a reasonable goal for the future.
AB - Background Inter-laboratory variability in quantifying pathogens involved in viral disease following transplantation may have a great impact on patient care, especially when pre-emptive strategies are used for prevention. Objectives The aim of this study was to analyze the variability in quantifying CMV, EBV and BKV DNA from 15 virology laboratories of the Italian Infections in Transplant Working Group (GLaIT) involved in monitoring transplanted patients. Study design Panels from international Quality Control programs for Molecular Diagnostics (QCMD, year 2012), specific for the detection of CMV in plasma, CMV in whole blood (WB), EBV and BKV were used. Intra- and inter-laboratory variability, as well as, deviations from QCMD consensus values were measured. Results 100% specificity was obtained with all panels. A sensitivity of 100% was achieved for EBV and BKV evaluations. Three CMV samples, with concentrations below 3 log10 copies/ml, were not detected by a few centers. Mean intra-laboratory variability (% CV) was 1.6 for CMV plasma and 3.0 for CMV WB. Mean inter-laboratory variability (% CV) was below 15% for all of the tested panels. Inter-laboratory variability was higher for CMV in WB with respect to the CMV plasma panel (3.0 vs 1.6% CV). The percentiles 87.7%, 58.6%, 89.6% and 74.7% fell within ± 0.5 log10 difference of the consensus values for CMV plasma, CMV WB, EBV and BKV panels, respectively. Conclusions An acceptable intra- and inter-laboratory variability, in comparison with international standards was observed in this study. However, further harmonization in viral genome quantification is a reasonable goal for the future.
KW - BKV-DNA
KW - EBV-DNA
KW - HCMV-DNA
KW - Multicenter evaluation
KW - Standardization
KW - Transplantation
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U2 - 10.1016/j.jcv.2016.07.001
DO - 10.1016/j.jcv.2016.07.001
M3 - Article
VL - 82
SP - 76
EP - 83
JO - Journal of Clinical Virology
JF - Journal of Clinical Virology
SN - 1386-6532
ER -