title: Performance of a completely automated system for monitoring CMV DNA in plasma.
abstract: Completely automated systems for monitoring CMV-DNA in plasma samples are now available.
  
  
  
  Evaluate analytical and clinical performances of the VERIS™/MDx System CMV Assay(®).
  
  
  
  Analytical performance was assessed using quantified quality controls. Clinical performance was assessed by comparison with the COBAS(®) Ampliprep™/COBAS(®) Taqman CMV test using 169 plasma samples that had tested positive with the in-house technique in whole blood.
  
  
  
  The specificity of the VERIS™/MDx System CMV Assay(®) was 99% [CI 95%: 97.7-100]. Intra-assay reproducibilities were 0.03, 0.04, 0.05 and 0.04 log10IU/ml (means 2.78, 3.70, 4.64 and 5.60 log10IU/ml) for expected values of 2.70, 3.70, 4.70 and 5.70 log10IU/ml. The inter-assay reproducibilities were 0.12 and 0.08 (means 6.30 and 2.85 log10IU/ml) for expected values of 6.28 and 2.80 log10IU/ml. The lower limit of detection was 14.6IU/ml, and the assay was linear from 2.34 to 5.58 log10IU/ml. The results for the positive samples were concordant (r=0.71, p<0.0001; slope of Deming regression 0.79 [CI 95%: 0.56-1.57] and y-intercept 0.79 [CI 95%: 0.63-0.95]). The VERIS™/MDx System CMV Assay(®) detected 18 more positive samples than did the COBAS(®) Ampliprep™/COBAS(®) Taqman CMV test and the mean virus load were higher (0.41 log10IU/ml). Patient monitoring on 68 samples collected from 17 immunosuppressed patients showed similar trends between the two assays. As secondary question, virus loads detected by the VERIS™/MDx System CMV Assay(®) were compared to those of the in-house procedure on whole blood. The results were similar between the two assays (-0.09 log10IU/ml) as were the patient monitoring trends.
  
  
  
  The performances of the VERIS™/MDx System CMV Assay(®) facilitated its routine use in monitoring CMV-DNA loads in plasma samples.
authors.affiliation: Department of Virology, Toulouse University Hospital, Toulouse, France. Electronic address: mengelle.c@chu-toulouse.fr.
authors.forename: C
authors.initials: C
authors.lastname: Mengelle
authors.affiliation: Department of Virology, Toulouse University Hospital, Toulouse, France; Department of Physiopathology, Toulouse Purpan, Unité Inserm U563, Toulouse, France.
authors.forename: K
authors.initials: K
authors.lastname: Sandres-Sauné
authors.affiliation: Department of Virology, Toulouse University Hospital, Toulouse, France.
authors.forename: J-M
authors.initials: JM
authors.lastname: Mansuy
authors.affiliation: Department of Virology, Toulouse University Hospital, Toulouse, France.
authors.forename: C
authors.initials: C
authors.lastname: Haslé
authors.affiliation: Department of Virology, Toulouse University Hospital, Toulouse, France.
authors.forename: J
authors.initials: J
authors.lastname: Boineau
authors.affiliation: Department of Virology, Toulouse University Hospital, Toulouse, France; Department of Physiopathology, Toulouse Purpan, Unité Inserm U563, Toulouse, France.
authors.forename: J
authors.initials: J
authors.lastname: Izopet
mesh_terms: D057205:Automation, Laboratory / Q000379:methods*; D003586:Cytomegalovirus Infections / Q000821:virology*; D004279:DNA, Viral / Q000097:blood*; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D010949:Plasma / Q000821:virology*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D004279:DNA, Viral
keywords: Automated; CMV; Plasma; Quantitation; Random access; Streamlined workflow