CLSI-based transference of CALIPER pediatric reference intervals to Beckman Coulter AU biochemical assays

Mohamed Abou El Hassan; Alexandra Stoianov; Petra A T Araújo; Tara Sadeghieh; Man Khun Chan; Yunqi Chen; Edward Randell; Michelle Nieuwesteeg; Khosrow Adeli

doi:10.1016/j.clinbiochem.2015.05.002

CLSI-based transference of CALIPER pediatric reference intervals to Beckman Coulter AU biochemical assays

Clin Biochem. 2015 Nov;48(16-17):1151-9. doi: 10.1016/j.clinbiochem.2015.05.002. Epub 2015 May 13.

Authors

Mohamed Abou El Hassan¹, Alexandra Stoianov², Petra A T Araújo², Tara Sadeghieh², Man Khun Chan², Yunqi Chen², Edward Randell³, Michelle Nieuwesteeg², Khosrow Adeli⁴

Affiliations

¹ 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.
² CALIPER Program, Department of Pediatric Laboratory Medicine, The Hospital of Sick Children, Toronto, ON, Canada.
³ Eastern Health, St. John's, NL, Canada.
⁴ 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.

PMID: 25979809
DOI: 10.1016/j.clinbiochem.2015.05.002

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.

Design and 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.

Conclusion: 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.

Keywords: Abbott; Beckman Coulter AU; CALIPER; Reference Intervals; Reference intervals; Routine chemistry markers.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Biological Assay / methods*
Biological Specimen Banks
Databases, Factual
Female
Humans
Male
Pediatrics / methods
Reference Standards*
Reference Values*

Grants and funding

Canadian Institutes of Health Research/Canada