title: Multi-center evaluation of analytical performance of the Beckman Coulter AU5822 chemistry analyzer.
abstract: OBJECTIVE
  Our three academic institutions, Indiana University, Northwestern Memorial Hospital, and Wake Forest, were among the first in the United States to implement the Beckman Coulter AU5822 series chemistry analyzers. We undertook this post-hoc multi-center study by merging our data to determine performance characteristics and the impact of methodology changes on analyte measurement.
  
  
  METHODS
  We independently completed performance validation studies including precision, linearity/analytical measurement range, method comparison, and reference range verification. Complete data sets were available from at least one institution for 66 analytes with the following groups: 51 from all three institutions, and 15 from 1 or 2 institutions for a total sample size of 12,064.
  
  
  RESULTS
  Precision was similar among institutions. Coefficients of variation (CV) were <10% for 97%. Analytes with CVs >10% included direct bilirubin and digoxin. All analytes exhibited linearity over the analytical measurement range. Method comparison data showed slopes between 0.900-1.100 for 87.9% of the analytes. Slopes for amylase, tobramycin and urine amylase were <0.8; the slope for lipase was >1.5, due to known methodology or standardization differences. Consequently, reference ranges of amylase, urine amylase and lipase required only minor or no modification.
  
  
  CONCLUSIONS
  The four AU5822 analyzers independently evaluated at three sites showed consistent precision, linearity, and correlation results. Since installations, the test results had been well received by clinicians from all three institutions.
authors.affiliation: Indiana University School of Medicine, Indianapolis, IN, USA.
authors.forename: M K
authors.initials: MK
authors.lastname: Zimmerman
authors.affiliation: Wake Forest Baptist Health, Winston-Salem, NC, USA.
authors.forename: L R
authors.initials: LR
authors.lastname: Friesen
authors.affiliation: Northwestern Memorial Hospital, Chicago, IL, USA.
authors.forename: A
authors.initials: A
authors.lastname: Nice
authors.affiliation: Indiana University Health, Indianapolis, IN, USA.
authors.forename: P A
authors.initials: PA
authors.lastname: Vollmer
authors.affiliation: Wake Forest Baptist Health, Winston-Salem, NC, USA.
authors.forename: E A
authors.initials: EA
authors.lastname: Dockery
authors.affiliation: Wake Forest Baptist Health, Winston-Salem, NC, USA.
authors.forename: J D
authors.initials: JD
authors.lastname: Rankin
authors.affiliation: Northwestern Memorial Hospital, Chicago, IL, USA.
authors.forename: K
authors.initials: K
authors.lastname: Zmuda
authors.affiliation: Wake Forest Baptist Health, Winston-Salem, NC, USA; Wake Forest School of Medicine, Winston-Salem, NC, USA. Electronic address: shwong@wakehealth.edu.
authors.forename: S H
authors.initials: SH
authors.lastname: Wong
mesh_terms: D001681:Biological Assay; D002624:Chemistry, Clinical / Q000295:instrumentation* / Q000379:methods*; D006801:Humans; D012016:Reference Values; D013223:Statistics as Topic
keywords: AU chemistry analyzer; Multi-center study; Performance evaluation; TDM and toxicology analyzers