title: CLSI-based transference of CALIPER pediatric reference intervals to Beckman Coulter AU biochemical assays.
abstract: OBJECTIVE
  The CALIPER program has established a comprehensive database of pediatric reference intervals using largely the Abbott ARCHITECT biochemical assays. To expand clinical application of CALIPER reference standards, the present study is aimed at transferring CALIPER reference intervals from the Abbott ARCHITECT to Beckman Coulter AU assays.
  
  
  METHODS
  Transference of CALIPER reference intervals was performed based on the CLSI guidelines C28-A3 and EP9-A2. The new reference intervals were directly verified using up to 100 reference samples from the healthy CALIPER cohort.
  
  
  RESULTS
  We found a strong correlation between Abbott ARCHITECT and Beckman Coulter AU biochemical assays, allowing the transference of the vast majority (94%; 30 out of 32 assays) of CALIPER reference intervals previously established using Abbott assays. Transferred reference intervals were, in general, similar to previously published CALIPER reference intervals, with some exceptions. Most of the transferred reference intervals were sex-specific and were verified using healthy reference samples from the CALIPER biobank based on CLSI criteria. It is important to note that the comparisons performed between the Abbott and Beckman Coulter assays make no assumptions as to assay accuracy or which system is more correct/accurate.
  
  
  CONCLUSIONS
  The majority of CALIPER reference intervals were transferrable to Beckman Coulter AU assays, allowing the establishment of a new database of pediatric reference intervals. This further expands the utility of the CALIPER database to clinical laboratories using the AU assays; however, each laboratory should validate these intervals for their analytical platform and local population as recommended by the CLSI.
authors.affiliation: CALIPER Program, Department of Pediatric Laboratory Medicine, The Hospital of Sick Children, Toronto, ON, Canada; Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada.
authors.forename: Mohamed
authors.initials: M
authors.lastname: Abou El Hassan
authors.affiliation: CALIPER Program, Department of Pediatric Laboratory Medicine, The Hospital of Sick Children, Toronto, ON, Canada.
authors.forename: Alexandra
authors.initials: A
authors.lastname: Stoianov
authors.affiliation: CALIPER Program, Department of Pediatric Laboratory Medicine, The Hospital of Sick Children, Toronto, ON, Canada.
authors.forename: Petra A T
authors.initials: PA
authors.lastname: Araújo
authors.affiliation: CALIPER Program, Department of Pediatric Laboratory Medicine, The Hospital of Sick Children, Toronto, ON, Canada.
authors.forename: Tara
authors.initials: T
authors.lastname: Sadeghieh
authors.affiliation: CALIPER Program, Department of Pediatric Laboratory Medicine, The Hospital of Sick Children, Toronto, ON, Canada.
authors.forename: Man Khun
authors.initials: MK
authors.lastname: Chan
authors.affiliation: CALIPER Program, Department of Pediatric Laboratory Medicine, The Hospital of Sick Children, Toronto, ON, Canada.
authors.forename: Yunqi
authors.initials: Y
authors.lastname: Chen
authors.affiliation: Eastern Health, St. John's, NL, Canada.
authors.forename: Edward
authors.initials: E
authors.lastname: Randell
authors.affiliation: CALIPER Program, Department of Pediatric Laboratory Medicine, The Hospital of Sick Children, Toronto, ON, Canada.
authors.forename: Michelle
authors.initials: M
authors.lastname: Nieuwesteeg
authors.affiliation: CALIPER Program, Department of Pediatric Laboratory Medicine, The Hospital of Sick Children, Toronto, ON, Canada; Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada. Electronic address: khosrow.adeli@sickkids.ca.
authors.forename: Khosrow
authors.initials: K
authors.lastname: Adeli
mesh_terms: D001681:Biological Assay / Q000379:methods*; D018070:Biological Specimen Banks; D016208:Databases, Factual; D005260:Female; D006801:Humans; D008297:Male; D010372:Pediatrics / Q000379:methods; D012015:Reference Standards; D012016:Reference Values
keywords: Abbott; Beckman Coulter AU; CALIPER; Reference Intervals; Reference intervals; Routine chemistry markers