title: Clinical evaluation of a fully automated CMV PCR assay.
abstract: BACKGROUND
  There is a growing need for sensitive high-throughput cytomegalovirus (CMV) PCR tests due to the increasing number of immunocompromised patients requiring monitoring for active CMV infection.
  
  
  OBJECTIVE
  To compare the fully automated COBAS(®) AmpliPrep/COBAS(®) TaqMan(®) (CAP/CTM) CMV test (this test is currently under development and not commercially available) for EDTA-plasma to the reference method COBAS(®) AMPLICOR CMV MONITOR.
  
  
  METHODS
  A prospective feasibility study with parallel analysis of 433 EDTA-plasma samples from 277 patients on both systems was carried out after the analytical performance of the new system had been assessed.
  
  
  RESULTS
  The new system has a wide linear range from 2.0 to 7.3 log(10) CMV-DNA copies/ml EDTA-plasma and a detection limit of 46 copies/ml with excellent accuracy and precision. When testing clinical samples, the CAP/CTM CMV test compared extremely well with the COBAS(®) AMPLICOR CMV MONITOR (R(2)=0.93, p<0.001) with increased sensitivity and linear range. Discrepant samples all contained low titers of CMV-DNA. In two of the study patients, CMV-DNAemia was detected by the CAP/CTM CMV test up to eight weeks earlier than by COBAS(®) AMPLICOR CMV MONITOR.
  
  
  CONCLUSIONS
  An IVD/CE marked version of the CAP/CTM CMV test will enable laboratories to provide a sensitive, fully automated high-throughput CMV PCR.
authors.affiliation: Division of Clinical Virology, Department of Laboratory Medicine, Medical University of Vienna, Währinger Gürtel 18-20, 1090 Vienna, Austria.
authors.forename: Heidrun
authors.initials: H
authors.lastname: Kerschner
authors.forename: Claudia
authors.initials: C
authors.lastname: Bauer
authors.forename: Peter
authors.initials: P
authors.lastname: Schlag
authors.forename: Sung
authors.initials: S
authors.lastname: Lee
authors.forename: Sebastian
authors.initials: S
authors.lastname: Goedel
authors.forename: Theresia
authors.initials: T
authors.lastname: Popow-Kraupp
mesh_terms: D001681:Biological Assay / Q000379:methods; D003587:Cytomegalovirus / Q000235:genetics*; D003586:Cytomegalovirus Infections / Q000097:blood / Q000821:virology*; D004279:DNA, Viral / Q000235:genetics*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D016867:Immunocompromised Host / Q000276:immunology; D008297:Male; D008875:Middle Aged; D016133:Polymerase Chain Reaction / Q000379:methods*; D011446:Prospective Studies
chemical_list: D004279:DNA, Viral