Accessible Requires Authentication Published by De Gruyter May 19, 2021

Pediatric reference interval verification for common biochemical assays on the Abbott Alinity system

Mary Kathryn Bohn, Siobhan Wilson, Alexandra Hall, Youssef Massamiri, Ed Randell and Khosrow Adeli

Abstract

Objectives

The quality of clinical laboratory service depends on quality laboratory operations and accurate test result interpretation based on reference intervals (RIs). As new analytical systems continue to be developed and improved, previously established RIs must be verified. The Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) has established comprehensive RIs for many biomarkers on several analytical systems. Here, published CALIPER RIs for 28 chemistry assays on the Abbott ARCHITECT were assessed for verification on the newer Alinity system.

Methods

An analytical validation was first completed to assess assay performance. CALIPER serum samples (100) were analyzed for 28 chemistry assays on the Alinity system. The percentage of results falling within published pediatric ARCHITECT reference and confidence limits was determined for each analyte. Based on Clinical and Laboratory Standards Institute (CLSI) guidelines, if ≥90% of test results fell within confidence limits of ARCHITECT assay RIs, they were considered verified.

Results

Of the 28 assays assessed, 26 met the criteria for verification. Reference values for calcium and magnesium did not meet the criteria for verification with 87% and 35% falling within previously established ARCHITECT confidence limits, respectively. However, both assays could be verified using pediatric RIs provided in the Abbott Alinity package insert.

Conclusions

In this study, CALIPER ARCHITECT RIs were verified on the Alinity system for several chemistry assays. These data demonstrate excellent concordance for most assays between the Abbott ARCHITECT and Alinity systems and will assist in the implementation of the Alinity system in pediatric healthcare institutions.


Corresponding author: Khosrow Adeli, CALIPER Program, Clinical Biochemistry, Pediatric Laboratory Medicine, The Hospital for Sick Children, 555 University Avenue, Toronto, ON, M5G 1X8 Canada; and Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada, E-mail:

Funding source: Canadian Institutes for Health Research

Funding source: Abbott Diagnostics

Acknowledgments

We would like to thank CALIPER participants without whom this work would not be possible. We would also like to thank, Adly Messiha, Dr. Vathany Kulasingam and UHN staff for assisting with the analytical validation on the Alinity system.

  1. Research funding: This work was supported by a Canadian Institutes for Health Research (CIHR) foundation grant to Khosrow Adeli. Mary Kathryn Bohn was supported by a CIHR Doctoral Award. Abbott Diagnostics also supported the study and provided all reagents at no cost.

  2. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  3. Competing interests: Authors state no conflict of interest.

  4. Informed consent: Informed consent was obtained from all individuals included in this study.

  5. Ethical approval: Study was approved by the Research Ethics Board at The Hospital for Sick Children.

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Supplementary Material

The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2021-0336).

Received: 2021-03-19
Accepted: 2021-05-11
Published Online: 2021-05-19
Published in Print: 2021-08-26

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