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.
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.
-
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.
-
Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
-
Competing interests: Authors state no conflict of interest.
-
Informed consent: Informed consent was obtained from all individuals included in this study.
-
Ethical approval: Study was approved by the Research Ethics Board at The Hospital for Sick Children.
References
1. Jung, B, Adeli, K. Clinical laboratory reference intervals in pediatrics: the CALIPER initiative. Clin Biochem 2009;42:1589–95. https://doi.org/10.1016/j.clinbiochem.2009.06.025.Search in Google Scholar PubMed
2. Horowitz, GL, Altaie, S, Boyd, JC. Defining, establishing, and verifying reference intervals in the clinical laboratory; approved guideline - third edition. Wayne, PA, U.S.A: CLSI; 2010.Search in Google Scholar
3. Adeli, K, Higgins, V, Trajcevski, K, White-Al Habeeb, N. The Canadian laboratory initiative on pediatric reference intervals: a CALIPER white paper. Crit Rev Clin Lab Sci 2017;54:358–413. https://doi.org/10.1080/10408363.2017.1379945.Search in Google Scholar PubMed
4. Zierk, J, Arzideh, F, Haeckel, R, Cario, H, Frühwald, MC, Groß, HJ, et al.. Pediatric reference intervals for alkaline phosphatase. Clin Chem Lab Med 2017;55:102–10. https://doi.org/10.1515/cclm-2016-0318.Search in Google Scholar PubMed
5. Adeli, K, Higgins, V, Trajcevski, K, Palmert, MR. Important considerations for interpreting biochemical tests in children. BMJ 2018;361. https://doi.org/10.1136/bmj.k1950.Search in Google Scholar PubMed
6. Hoq, M, Matthews, S, Karlaftis, V, Burgess, J, Cowley, J, Donath, S, et al.. Reference values for 30 common biochemistry analytes across 5 different analyzers in neonates and children 30 days to 18 years of age. Clin Chem 2019;65:1317–26. https://doi.org/10.1373/clinchem.2019.306431.Search in Google Scholar PubMed
7. Clifford, SM, Bunker, AM, Jacobsen, JR, Roberts, WL. Age and gender specific pediatric reference intervals for aldolase, amylase, ceruloplasmin, creatine kinase, pancreatic amylase, prealbumin, and uric acid. Clin Chim Acta 2011;412:788–90. https://doi.org/10.1016/j.cca.2011.01.011.Search in Google Scholar PubMed
8. Kohse, KP. KiGGS - the German survey on children’s health as data base for reference intervals and beyond. Clin Biochem 2014;47:742–3. https://doi.org/10.1016/j.clinbiochem.2014.05.039.Search in Google Scholar PubMed
9. Telford, RD, Bass, SL, Budge, MM, Byrne, DG, Carlson, JS, Coles, D, et al.. The lifestyle of our kids (LOOK) project: outline of methods. J Sci Med Sport 2009;12:156–63. https://doi.org/10.1016/j.jsams.2007.03.009.Search in Google Scholar PubMed
10. Zierk, J, Arzideh, F, Haeckel, R, Rauh, M, Metzler, M, Ganslandt, T, et al.. Indirect determination of hematology reference intervals in adult patients on Beckman Coulter UniCell DxH 800 and Abbott CELL-DYN Sapphire devices. Clin Chem Lab Med 2019;57:730–9. https://doi.org/10.1515/cclm-2018-0771.Search in Google Scholar PubMed
11. Zierk, J, Arzideh, F, Rechenauer, T, Haeckel, R, Rascher, W, Metzler, M, et al.. Age- and sex-specific dynamics in 22 hematologic and biochemical analytes from birth to adolescence. Clin Chem 2015;61:964–73. https://doi.org/10.1373/clinchem.2015.239731.Search in Google Scholar PubMed
12. Colantonio, DA, Kyriakopoulou, L, Chan, MK, Daly, CH, Brinc, D, Venner, AA, et al.. Closing the gaps in pediatric laboratory reference intervals: a caliper database of 40 biochemical markers in a healthy and multiethnic population of children. Clin Chem 2012;58:854–68. https://doi.org/10.1373/clinchem.2011.177741.Search in Google Scholar PubMed
13. Estey, MP, Cohen, AH, Colantonio, DA, Chan, MK, Marvasti, TB, Randell, E, et al.. 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. Clin Biochem 2013;46:1197–219. https://doi.org/10.1016/j.clinbiochem.2013.04.001.Search in Google Scholar PubMed
14. Higgins, V, Chan, MK, Nieuwesteeg, M, Hoffman, BR, Bromberg, IL, Gornall, D, et al.. Transference of CALIPER pediatric reference intervals to biochemical assays on the Roche cobas 6000 and the Roche Modular P. Clin Biochem 2016;49:139–49. https://doi.org/10.1016/j.clinbiochem.2015.08.018.Search in Google Scholar PubMed
15. Higgins, V, Truong, D, Woroch, A, Chan, MK, Tahmasebi, H, Adeli, K. CLSI-based transference and verification of CALIPER pediatric reference intervals for 29 Ortho VITROS 5600 chemistry assays. Clin Biochem 2018;53:93–103. https://doi.org/10.1016/j.clinbiochem.2017.12.011.Search in Google Scholar PubMed
16. Abou El Hassan, M, Stoianov, A, Araújo, PAT, Sadeghieh, T, Chan, MK, Chen, Y, et al.. CLSI-based transference of CALIPER pediatric reference intervals to Beckman Coulter AU biochemical assays. Clin Biochem 2015;48:1151–9. https://doi.org/10.1016/j.clinbiochem.2015.05.002.Search in Google Scholar PubMed
17. Araújo, PAT, Thomas, D, Sadeghieh, T, Bevilacqua, V, Chan, MK, Chen, Y, et al.. CLSI-based transference of the CALIPER database of pediatric reference intervals to Beckman Coulter DxC biochemical assays. Clin Biochem 2015;48:870–80. https://doi.org/10.1016/j.clinbiochem.2015.06.002.Search in Google Scholar PubMed
18. Taher, J, Cosme, J, Renley, BA, Daghfal, DJ, Yip, PM. A novel Sigma metric encompasses global multi-site performance of 18 assays on the Abbott Alinity system. Clin Biochem 2019;63:106–12. https://doi.org/10.1016/j.clinbiochem.2018.10.003.Search in Google Scholar PubMed
19. EP05-A3 evaluation of precision of quantitative measurement procedures; approved guideline-third edition [Internet]. Available from: www.clsi.org [Accessed 18 Oct 2020].Search in Google Scholar
20. EP06-A evaluation of the linearity of quantitative measurement procedures: a statistical approach; approved guideline [Internet]. Available from: www.clsi.org [Accessed 26 Jun 2020].Search in Google Scholar
Supplementary Material
The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2021-0336).
© 2021 Walter de Gruyter GmbH, Berlin/Boston
