Nation-wide measure of variability in HCMV, EBV and BKV DNA quantification among centers involved in monitoring transplanted patients

被引:8
作者
Abbate, Isabella [1 ]
Piralla, Antonio [2 ]
Calvario, Agata [3 ]
Callegaro, Annapaola [4 ]
Giraldi, Cristina [5 ]
Lunghi, Giovanna [6 ]
Gennari, William [7 ]
Sodano, Giuseppe [8 ]
Ravanini, Paolo [9 ]
Conaldi, Pier Giulio [10 ]
Vatteroni, Marialinda [11 ]
Gaeta, Aurelia [12 ]
Paba, Pierpaolo [13 ]
Cavallo, Rossana [14 ]
Baldanti, Fausto [2 ,15 ]
Lazzarotto, Tiziana [16 ]
机构
[1] INMI L Spallanzani, Virol Lab, Rome, Italy
[2] Fdn IRCCS Policlin San Matteo, SC Microbiol & Virol, SS Virol Mol, Pavia, Italy
[3] Policlin Bari, UOC Microbiol & Virol, Bari, Italy
[4] Osped Riuniti Bergamo, UO Microbiol & Virol, Bergamo, Italy
[5] PO Annunziata AO, UO Microbiol & Virol, Cosenza, Italy
[6] IRCCS Osped Maggiore Policlin Mangiagalli & Regin, Virol Lab, Milan, Italy
[7] Azienda Osped Univ Modena, UO Microbiol & Virol, Modena, Italy
[8] Osped Monaldi Cotugno CTO, AORN Azienda Osped Colli, UOC Microbiol & Virol, Naples, Italy
[9] Osped Maggiore La Carita, UO Microbiol & Virol, Novara, Italy
[10] Lab Patol Clin Microbiol & Virol ISMETT, Palermo, Italy
[11] Azienda Osped Univ Pisana, UO Virol, Pisa, Italy
[12] Policlin Umberto I Sapienza, UOC Virol, Rome, Italy
[13] Policlin Fdn Tor Vergata, UOC Virol Mol, Rome, Italy
[14] Univ Turin, AOU Citta Salute & Sci, SC Microbiol & Virol, I-10124 Turin, Italy
[15] Univ Pavia, Dipartimento Sci Clin Chirurg Diagnost & Pediat, Sez Microbiol, Pavia, Italy
[16] Univ Bologna, Policlin S Orsola Malpighi, DIMES, UO Microbiol, Bologna, Italy
关键词
Multicenter evaluation; Standardization; Transplantation; HCMV-DNA; EBV-DNA; BKV-DNA; EPSTEIN-BARR-VIRUS; VIRAL LOAD ASSAYS; NUCLEIC-ACID EXTRACTION; WHOLE-BLOOD; CYTOMEGALOVIRUS; DNAEMIA; POLYOMAVIRUS; RECIPIENTS; INFECTION; PCR;
D O I
10.1016/j.jcv.2016.07.001
中图分类号
Q93 [微生物学];
学科分类号
071005 ; 100705 ;
摘要
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 log(10) 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 log(10) 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. (C) 2016 Elsevier B.V. All rights reserved.
引用
收藏
页码:76 / 83
页数:8
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