PMID- 20147642 OWN - NLM STAT- MEDLINE DCOM- 20101008 LR - 20211020 IS - 1098-660X (Electronic) IS - 0095-1137 (Print) IS - 0095-1137 (Linking) VI - 48 IP - 7 DP - 2010 Jul TI - Multicenter external quality assessment of molecular methods for detection of human herpesvirus 6. PG - 2536-40 LID - 10.1128/JCM.01145-09 [doi] AB - The purpose of this study was to evaluate the performance of laboratories for the detection and quantification of human herpesvirus 6 (HHV-6) by an external quality assessment (EQA) evaluation. The HHV-6 EQA panel consisted of eight samples containing various concentrations of HHV-6 type A (strain GS) or type B (strain Z29), two samples containing other herpesviruses (i.e., human cytomegalovirus [HCMV] and Epstein-Barr virus [EBV]), and two HHV-6-negative samples. Panel samples were prepared in human plasma, heat inactivated, and lyophilized. Panel distribution, data management, and analysis were coordinated by Quality Control for Molecular Diagnostics (QCMD), Glasgow, United Kingdom. Fifty-one laboratories participated and submitted 57 data sets. Eleven (19.3%) data sets were generated using conventional in-house assays, 11 (19.3%) data sets using commercial real-time PCR assays, and 35 (61.4%) data sets using in-house real-time PCR assays. The presence of HHV-6 DNA at viral loads exceeding 6,000 copies/ml was detected by all participants, and over 80% of the participants still reported correct qualitative results for the sample containing just over 200 copies/ml. The false-positivity rate was 1.8% for both the negative samples and the samples containing HCMV or EBV DNA. The majority (23/33; 69.7%) of quantitative data sets were generated using in-house real-time PCR assays. The standard deviations of the geometric means of the samples ranged from 0.5 to 0.7 log(10). The results of this first international EQA demonstrate encouraging analytical sensitivity for the detection of HHV-6-DNA in human plasma, although we observed extensive interlaboratory variation of quantitative HHV-6 DNA results. Standardization needs to be improved to allow further elucidation of the clinical significance of HHV-6 loads. FAU - de Pagter, P J AU - de Pagter PJ AD - University Medical Center Utrecht, Department of Virology, Utrecht, Netherlands. p.j.depagter@umcutrecht.nl FAU - Schuurman, R AU - Schuurman R FAU - de Vos, N M AU - de Vos NM FAU - Mackay, W AU - Mackay W FAU - van Loon, A M AU - van Loon AM LA - eng PT - Journal Article PT - Multicenter Study DEP - 20100210 PL - United States TA - J Clin Microbiol JT - Journal of clinical microbiology JID - 7505564 RN - 0 (DNA, Viral) SB - IM MH - DNA, Viral/analysis/isolation & purification MH - False Positive Reactions MH - *Herpesvirus 6, Human/genetics/isolation & purification MH - Humans MH - Laboratories/standards MH - *Molecular Diagnostic Techniques/methods/standards MH - Polymerase Chain Reaction MH - Quality Control MH - Roseolovirus Infections/diagnosis MH - Viral Load/*methods MH - Virology/*methods PMC - PMC2897485 EDAT- 2010/02/12 06:00 MHDA- 2010/10/12 06:00 PMCR- 2011/01/01 CRDT- 2010/02/12 06:00 PHST- 2010/02/12 06:00 [entrez] PHST- 2010/02/12 06:00 [pubmed] PHST- 2010/10/12 06:00 [medline] PHST- 2011/01/01 00:00 [pmc-release] AID - JCM.01145-09 [pii] AID - 1145-09 [pii] AID - 10.1128/JCM.01145-09 [doi] PST - ppublish SO - J Clin Microbiol. 2010 Jul;48(7):2536-40. doi: 10.1128/JCM.01145-09. Epub 2010 Feb 10.