Abstract
Objectives
The Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) has developed an extensive database of reference intervals (RIs) for several biomarkers on various analytical systems. In this study, pediatric RIs were verified for key immunoassays on the Abbott Alinity system based on the analysis of healthy children samples and comparison to comprehensive RIs previously established for Abbott ARCHITECT assays.
Methods
Analytical performance of Alinity immunoassays was first assessed. Subsequently, 100 serum samples from healthy children recruited with informed consent were analyzed for 16 Alinity immunoassays. The percentage of test results falling within published CALIPER ARCHITECT reference and confidence limits was determined. If ≥ 90% of test results fell within the confidence limits, they were considered verified based on CLSI guidelines. If <90% of test results fell within the confidence limits, additional samples were analyzed and new Alinity RIs were established.
Results
Of the 16 immunoassays assessed, 13 met the criteria for verification with test results from ≥ 90% of healthy serum samples falling within the published ARCHITECT confidence limits. New CALIPER RIs were established for free thyroxine and prolactin on the Alinity system. Estradiol required special considerations in early life.
Conclusions
Our data demonstrate excellent concordance between ARCHITECT and Alinity immunoassays, as well as the robustness of previously established CALIPER RIs for most immunoassays, eliminating the need for de novo RI studies for most parameters. Availability of pediatric RIs for immunoassays on the Alinity system will assist clinical laboratories using this new platform and contribute to improved clinical decision-making.
Funding source: Canadian Institutes for Health Research
Award Identifier / Grant number: 353989
Acknowledgments
We would like to thank CALIPER participants without whom this work would not be possible. We would also like to thank Dr. Vathany Kulasingam and UHN staff for assisting with the analytical validation on the Alinity system.
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Research funding: This work was supported by a Canadian Institutes for Health Research (CIHR) foundation grant to Khosrow Adeli (grant no. 353989). Mary Kathryn Bohn was supported by a CIHR Doctoral Award. Abbott Diagnostics also supported the study and provided all reagents at no cost.
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Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
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Competing interests: Authors state no conflict of interest.
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Informed consent: Informed consent was obtained from all individuals included in this study.
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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-2021-0337).
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