title: Traceability Assessment and Performance Evaluation of Results for Measurement of Abbott Clinical Chemistry Assays on 4 Chemistry Analyzers.
abstract: BACKGROUND
  -The traceability of clinical results to internationally recognized and accepted reference materials and reference measurement procedures has become increasingly important. Therefore, the establishment of traceability has become a mandatory requirement for all in vitro diagnostics devices.
  
  
  OBJECTIVE
  -To evaluate the traceability of the Abbott Architect c8000 system (Abbott Laboratories, Abbott Park, Illinois), consisting of calibrators and reagents, across 4 different chemistry analyzers, and to evaluate its general performance on the Toshiba 2000FR NEO (Toshiba Medical Systems Corporation, Otawara-shi, Tochigi-ken, Japan).
  
  
  METHODS
  -For assessment of traceability, secondary reference materials were evaluated 5 times, and then bias was calculated. Precision, linearity, and carryover were determined according to the guidelines of the Clinical and Laboratory Standards Institute (Wayne, Pennsylvania).
  
  
  RESULTS
  -The biases from 4 different analyzers ranged from -2.33% to 2.70% on the Toshiba 2000FR NEO, -2.33% to 5.12% on the Roche Hitachi 7600 (Roche Diagnostics International, Basel, Switzerland), -0.93% to 2.87% on the Roche Modular, and -2.16% to 2.86% on the Abbott Architect c16000. The total coefficients of variance of all analytes were less than 5%. The coefficients of determination (R(2)) were more than 0.9900. The carryover rate ranged from -0.54% to 0.17%.
  
  
  CONCLUSIONS
  -Abbott clinical chemistry assays met the performance criteria based on desirable biological variation for precision, bias, and total error. They also showed excellent linearity and carryover. Therefore, these clinical chemistry assays were found to be accurate and reliable and are readily applicable on the various platforms used in this study.
authors.forename: Jinsook
authors.initials: J
authors.lastname: Lim
authors.forename: Kyung Eun
authors.initials: KE
authors.lastname: Song
authors.forename: Sang Hoon
authors.initials: SH
authors.lastname: Song
authors.forename: Hyun-Jung
authors.initials: HJ
authors.lastname: Choi
authors.forename: Sun Hoe
authors.initials: SH
authors.lastname: Koo
authors.affiliation: From the Department of Laboratory Medicine, Chungnam National University Hospital, Daejeon, South Korea (Drs Lim, Koo, and Kwon); the Department of Laboratory Medicine, Kyungpook National University Hospital, Daegu, South Korea (Dr K.E. Song); the Department of Laboratory Medicine, Seoul National University Hospital and College of Medicine, Seoul, South Korea (Dr S.H. Song); the Department of Laboratory Medicine, Chonnam National University Hospital, Gwangju, South Korea (Dr Choi).
authors.forename: Gye Choel
authors.initials: GC
authors.lastname: Kwon
mesh_terms: D000465:Algorithms; D057205:Automation, Laboratory / Q000295:instrumentation*; D001774:Blood Chemical Analysis / Q000295:instrumentation* / Q000592:standards; D002138:Calibration; D003951:Diagnostic Errors / Q000517:prevention & control*; D006785:Hospitals, University; D006801:Humans; D016014:Linear Models; D008422:Materials Testing; D017410:Practice Guidelines as Topic; D011786:Quality Control; D011787:Quality of Health Care; D012015:Reference Standards; D015203:Reproducibility of Results; D056910:Republic of Korea