title: CLSI-based transference of the CALIPER database of pediatric reference intervals from Abbott to Beckman, Ortho, Roche and Siemens Clinical Chemistry Assays: direct validation using reference samples from the CALIPER cohort.
abstract: OBJECTIVE
  The CALIPER program recently established a comprehensive database of age- and sex-stratified pediatric reference intervals for 40 biochemical markers. However, this database was only directly applicable for Abbott ARCHITECT assays. We therefore sought to expand the scope of this database to biochemical assays from other major manufacturers, allowing for a much wider application of the CALIPER database.
  
  
  METHODS
  Based on CLSI C28-A3 and EP9-A2 guidelines, CALIPER reference intervals were transferred (using specific statistical criteria) to assays performed on four other commonly used clinical chemistry platforms including Beckman Coulter DxC800, Ortho Vitros 5600, Roche Cobas 6000, and Siemens Vista 1500. The resulting reference intervals were subjected to a thorough validation using 100 reference specimens (healthy community children and adolescents) from the CALIPER bio-bank, and all testing centers participated in an external quality assessment (EQA) evaluation.
  
  
  RESULTS
  In general, the transferred pediatric reference intervals were similar to those established in our previous study. However, assay-specific differences in reference limits were observed for many analytes, and in some instances were considerable. The results of the EQA evaluation generally mimicked the similarities and differences in reference limits among the five manufacturers' assays. In addition, the majority of transferred reference intervals were validated through the analysis of CALIPER reference samples.
  
  
  CONCLUSIONS
  This study greatly extends the utility of the CALIPER reference interval database which is now directly applicable for assays performed on five major analytical platforms in clinical use, and should permit the worldwide application of CALIPER pediatric reference intervals.
authors.affiliation: CALIPER Program, Department of Pediatric Laboratory Medicine, The Hospital for Sick Children, Canada.
authors.forename: Mathew P
authors.initials: MP
authors.lastname: Estey
authors.forename: Ashley H
authors.initials: AH
authors.lastname: Cohen
authors.forename: David A
authors.initials: DA
authors.lastname: Colantonio
authors.forename: Man Khun
authors.initials: MK
authors.lastname: Chan
authors.forename: Tina Binesh
authors.initials: TB
authors.lastname: Marvasti
authors.forename: Edward
authors.initials: E
authors.lastname: Randell
authors.forename: Edgard
authors.initials: E
authors.lastname: Delvin
authors.forename: Jocelyne
authors.initials: J
authors.lastname: Cousineau
authors.forename: Vijaylaxmi
authors.initials: V
authors.lastname: Grey
authors.forename: Donald
authors.initials: D
authors.lastname: Greenway
authors.forename: Qing H
authors.initials: QH
authors.lastname: Meng
authors.forename: Benjamin
authors.initials: B
authors.lastname: Jung
authors.forename: Jalaluddin
authors.initials: J
authors.lastname: Bhuiyan
authors.forename: David
authors.initials: D
authors.lastname: Seccombe
authors.forename: Khosrow
authors.initials: K
authors.lastname: Adeli
mesh_terms: D015415:Biomarkers; D002624:Chemistry, Clinical; D016208:Databases, Factual; D004345:Drug Industry; D006801:Humans; D010372:Pediatrics; D012015:Reference Standards
chemical_list: D015415:Biomarkers
keywords: Abbott; Beckman; Biochemical markers; CALIPER; CEQAL; CLSI; Canadian External Quality Assessment Laboratory; Canadian Laboratory Initiative in Pediatric Reference Intervals; Clinical Laboratory Standards Institute; EQA; External quality assessment; Ortho; Pediatric; Q–Q; Reference intervals; Roche; Siemens; Transference; quantile–quantile