title: Performance characteristics of the Coulter LH 500 hematology analyzer.
abstract: The challenge for modern hematology laboratories is to provide accurate and reproducible results, with seamless performance between facilities, in a cost-effective manner. Beckman Coulter recently developed the Coulter LH 500 to meet the needs of smaller laboratories or serve as a backup in larger laboratories. The principal goal of this study was to validate all parameters and performance specifications of the LH 500 compared to the Coulter LH 750 predicate analyzer. A total of 245 spent clinical samples from the London Health Sciences Centre (LHSC) and 251 from the University of Pittsburgh Medical Center Health System (UPMCHS) were analyzed during the study. The samples were selected to include 75% abnormal and 25% normal blood samples. According to the results of a rank sum test, there was no significant difference between the LH 500 and LH 750 for all complete blood count parameters (P > .05) except the red cell distribution width, which showed a slight negative bias on the LH 500. Differential parameters comparing the LH 500 to a 400-cell manual differential showed correlation coefficients (r2) from 0.75 to 0.99 for all parameters except basophils. Of the samples run on the LH 500 at LHSC, the false-positive differential flagging rate was 17.32% and the false-negative rate was 3.03%. Sensitivity was 82.93%, specificity 78.95%, and efficiency 79.65%. At UPMCHS, the false-positive differential flagging rate was 13.37% and false-negative rate 2.97%. Sensitivity was 91.89%, specificity 78.91%, and efficiency 83.66%. Overall, the LH 500 performed accurately and reproducibly compared to the LH 750 and the reference procedures. It would be an excellent second instrument for larger laboratories concerned with harmonization of instrumentation and reagents or as a primary instrument for smaller hematology laboratories with limited space.
authors.affiliation: University of Pittsburgh Medical Center, Presbyterian University Hospital, Pittsburgh, Pennsylvania 15213, USA.
authors.forename: Sandra S
authors.initials: SS
authors.lastname: Kaplan
authors.forename: Kathleen
authors.initials: K
authors.lastname: Johnson
authors.forename: Nancy
authors.initials: N
authors.lastname: Wolfe
authors.forename: Wendy
authors.initials: W
authors.lastname: Brown
authors.forename: Michael
authors.initials: M
authors.lastname: Keeney
authors.forename: Leslie
authors.initials: L
authors.lastname: Gray-Statchuk
authors.forename: Ian Chin
authors.initials: IC
authors.lastname: Yee
mesh_terms: D001772:Blood Cell Count / Q000295:instrumentation* / Q000592:standards*; D004526:Efficiency; D005069:Evaluation Studies as Topic; D005188:False Negative Reactions; D006801:Humans; D011786:Quality Control; D012015:Reference Standards; D012016:Reference Values; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity