Multicenter quality control study for human cytomegalovirus DNAemia quantification

Daniele Lilleri, Tiziana Lazzarotto, Valeria Ghisetti, Paolo Ravanini, Maria R. Capobianchi, Fausto Baldanti, Giuseppe Gerna

Research output: Contribution to journalArticlepeer-review


Standardized protocols and methods for virological monitoring are mandatory for the correct surveillance of human cytomegalovirus (HCMV) infection in transplanted patients receiving pre-emptive therapy. Fifteen Italian viral diagnostic laboratories belonging to different transplantation centers participated in the external Quality Control Programme for Molecular Diagnostics of HCMV-DNA by using two in-house and five commercial methods for HCMV-DNA quantification. The different methods shared 100% specificity, and sensitivity reached 100% when samples containing > 1,000 copies/ml were considered. The variability range was wide (about 2 log 10) for samples containing a lower amount of HCMV-DNA (<1,000 copies/ml), but it decreased with increasing concentrations of HCMV-DNA. For HCMV-DNA levels ≥5,000 copies/ml, the different methods provided results within a ±0.5 log 10 variability range, while the 80% range (range in which 80% of results obtained will fall) was within ±0.3 log 10 or less. An acceptable level of variability was reached among different in-house and commercial methods for HCMV-DNA quantification in samples containing a clinically significant viral DNA amount. Based on these data, standardized cutoffs established for pre-emptive therapy in different transplantation centers should provide comparable clinical and virological results among centers.

Original languageEnglish
Pages (from-to)245-253
Number of pages9
JournalNew Microbiologica
Issue number3
Publication statusPublished - Jul 2009


  • DNAemia
  • Human cytomegalovirus
  • Standardization
  • Transplantation

ASJC Scopus subject areas

  • Microbiology (medical)


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