title: Enhanced flagging and improved clinical sensitivity on the new DxH 300(TM) Coulter(®) cellular analysis system.
abstract: BACKGROUND
  The Beckman Coulter DxH 300™ is a hematology analyzer that performs a CBC and 3-part WBC differential and incorporates new electronic, algorithm and mechanical design.
  
  
  METHODS
  This instrument was compared with the predicate analyzer (Coulter(®) A(c) ·Tdiff2) and the larger format Coulter LH780 analyzer. Of interest were flagging rates, clinical sensitivity, and accuracy of the WBC in the presence of interfering particles. The total sample set (n = 404) consisted of morphologically normal and hematologically abnormal patients.
  
  
  RESULTS
  Correlation of the DxH 300 with A(c) ·Tdiff2™ showed good agreement with all directly measured parameters. When compared with the LH780, WBC and platelets (PLT) counts showed good agreement with small biases. Importantly in the low range (PLT <50 × 10(9) /L), there was a small positive bias of only 2 × 10(9) /L PLT. Interfering particles did not affect the DxH 300 WBC count (P > 0.05) with strong correlations to the LH780 (r(2) values >0.95). Importantly, overall and specific flagging rates as well as false-negative and false-positive rates were significantly reduced on the DxH 300 compared with the A(c) ·Tdiff2 (27% and 41% reduction, respectively, P < 0.001).
  
  
  CONCLUSIONS
  The DxH 300 offers significant improvement over the predicate Coulter analyzer in flagging rates and improved correlation with larger format analyzers for WBC and PLT counts. Reduced false negatives and false positives significantly improved sensitivity and specificity compared to the predicate analyzer. The 28% improvement in flagging efficiency together with numerous software and data handling enhancements should translate into reduced need to perform follow-up analysis on a significant number of samples.
authors.affiliation: Department of Haematology, London Health Sciences Centre, London, ON, Canada.
authors.forename: B D
authors.initials: BD
authors.lastname: Hedley
authors.forename: C
authors.initials: C
authors.lastname: Phay
authors.forename: I
authors.initials: I
authors.lastname: Chin-Yee
authors.forename: W
authors.initials: W
authors.lastname: Brown
authors.forename: M
authors.initials: M
authors.lastname: Keeney