Abstract
Objectives
Recently, Abbott Diagnostics marketed a new generation of Alinity enzyme assays, introducing a multiparametric calibrator [Consolidated Chemistry Calibrator (ConCC)] in place of or in addition to factor-based calibrations. For alkaline phosphatase (ALP), both calibration options are offered, i.e., with ConCC (ALP2) and with an experimental calibration factor (ALP2F). Both options are declared traceable to the 2011 IFCC reference measurement procedure (RMP). Before to replace the old generation (ALP1) with the new one, we decided to validate the trueness of ALP2/ALP2F.
Methods
Three approaches were employed: (a) preliminary comparison on 48 native frozen serum samples with ALP1, of which traceability to RMP was previously successfully verified; (b) examination of three banked serum pools (BSP) with values assigned by RMP; (c) direct comparison with RMP on a set of 24 fresh serum samples. Bias estimation and regression studies were performed, and the standard measurement uncertainty associated with ALP measurements on clinical samples (uresult) was estimated and compared with established analytical performance specifications (APS). ConCC commutability was also assessed.
Results
A positive proportional bias was found with both ALP2 and ALP2F when compared to ALP1 and RMP. This positive bias was confirmed on BSP: in average, +13.1 % for ALP2 and +10.0 % for ALP2F, respectively. uresult were 13.28 % for ALP2 and 10.04 % for ALP2F, both not fulfilling the minimum APS of 4.0 %. Furthermore, ConCC was not commutable with clinical samples.
Conclusions
Our results unearth problems in the correct implementation of traceability of Alinity ALP2/ALP2F, with the risk for the new assay to be unfit for clinical purposes.
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Research ethics: Not applicable.
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Informed consent: Not applicable.
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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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Research funding: None declared.
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Data availability: Not applicable.
References
1. Panteghini, M. Serum enzymes. In: Rifai, N, Chiu, RWK, Young, I, Burnham, CAD, Wittwer, CT, editors. Tietz textbook of laboratory medicine, 7th ed. St. Louis: Elsevier; 2023:350 p.Search in Google Scholar
2. Infusino, I, Schumann, G, Ceriotti, F, Panteghini, M. Standardization in clinical enzymology: a challenge for the theory of metrological traceability. Clin Chem Lab Med 2010;48:301–7. https://doi.org/10.1515/cclm.2010.075.Search in Google Scholar PubMed
3. Infusino, I, Frusciante, E, Braga, F, Panteghini, M. Progress and impact of enzyme measurement standardization. Clin Chem Lab Med 2017;55:334–40. https://doi.org/10.1515/cclm-2016-0661.Search in Google Scholar PubMed
4. Schumann, G, Klauke, R, Canalias, F, Bossert-Reuther, S, Franck, PF, Gella, FJ, et al.. IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37 °C. Part 9: reference procedure for the measurement of catalytic concentration of alkaline phosphatase. Clin Chem Lab Med 2011;49:1439–46. https://doi.org/10.1515/cclm.2011.621.Search in Google Scholar PubMed
5. Aloisio, E, Frusciante, E, Pasqualetti, S, Quercioli, M, Panteghini, M. Traceability of alkaline phosphatase measurement may also vary considerably using the same analytical system: the case of Abbott architect. Clin Chem Lab Med 2018;56:135–7. https://doi.org/10.1515/cclm-2017-1007.Search in Google Scholar PubMed
6. Braga, F, Frusciante, E, Infusino, I, Aloisio, E, Guerra, E, Ceriotti, F, et al.. Evaluation of the trueness of serum alkaline phosphatase measurement in a group of Italian laboratories. Clin Chem Lab Med 2017;55:47–50. https://doi.org/10.1515/cclm-2016-0605.Search in Google Scholar PubMed
7. Wang, J, Wang, Y, Zhang, T, Zeng, J, Zhao, H, Guo, Q, et al.. Evaluation of serum alkaline phosphatase measurement through the 4-year trueness verification program in China. Clin Chem Lab Med 2018;56:2072–8. https://doi.org/10.1515/cclm-2018-0399.Search in Google Scholar PubMed
8. Aloisio, E, Frusciante, E, Pasqualetti, S, Infusino, I, Krintus, M, Sypniewska, G, et al.. Traceability validation of six enzyme measurements on the Abbott Alinity c analytical system. Clin Chem Lab Med 2020;58:1250–6. https://doi.org/10.1515/cclm-2020-0015.Search in Google Scholar PubMed
9. Rosler, E, Yahalom, D, Lennartz, L, Armbruster, D, Orth, M. Traceability of architect enzyme assays to IFCC reference methods – an international study. Clin Chem 2012;58:A178.Search in Google Scholar
10. Armbruster, D, Yahalom, D, Lennartz, L, Orth, M. Metrological traceability of architect amylase and alkaline phosphatase assays to IFCC reference methods. Clin Chem 2015;61:S208–9.Search in Google Scholar
11. Abbott. Clinical chemistry and immunoassay traceability and measurement uncertainty guide. Alinity ci-series/architect ci systems, 7th ed; 2022.Search in Google Scholar
12. Bianchi, G, Colombo, G, Pasqualetti, S, Panteghini, M. Alignment of the new generation of Abbott Alinity γ-glutamyltransferase assay to the IFCC reference measurement system should be improved. Clin Chem Lab Med 2022;60:e228–31. https://doi.org/10.1515/cclm-2022-0684.Search in Google Scholar PubMed
13. ISO 17511:2020. In vitro diagnostic medical devices — requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples. Geneva, Switzerland: ISO; 2020.Search in Google Scholar
14. Clinical and Laboratory Standards Institute (CLSI). EP09-A3—measurement procedure comparison and bias estimation using patient samples; approved guideline, 3rd ed. Wayne, PA: Clinical and Laboratory Standards Institute; 2013.Search in Google Scholar
15. Panteghini, M, Infusino, I. Enzyme and rate analyses. In: Rifai, N, Chiu, RWK, Young, I, Burnham, CAD, Wittwer, CT, editors. Tietz textbook of laboratory medicine, 7th ed. St. Louis: Elsevier; 2023:300 p.Search in Google Scholar
16. Danilenko, U, Vesper, HW, Myers, GL, Clapshaw, PA, Camara, JE, Miller, WG. An updated protocol based on CLSI document C37 for preparation of off-the-clot serum from individual units for use alone or to prepare commutable pooled serum reference materials. Clin Chem Lab Med 2020;58:368–74. https://doi.org/10.1515/cclm-2019-0732.Search in Google Scholar PubMed PubMed Central
17. Ceriotti, F, Ferrero, CA, Guerra, E, Bonora, R, Panteghini, M. Aminomethyl-propanol (AMP) and N-methyl-glucamine (MEG) buffers for alkaline phosphatase measurement: effects on commutability of control materials. Biochim Clin 2005;29:486–94.Search in Google Scholar
18. ISO/TS 20914:2019. Medical laboratories – practical guidance for the estimation of measurement uncertainty, 1st ed. Geneva, Switzerland: ISO; 2019.Search in Google Scholar
19. Braga, F, Panteghini, M. The utility of measurement uncertainty in medical laboratories. Clin Chem Lab Med 2020;58:1407–13. https://doi.org/10.1515/cclm-2019-1336.Search in Google Scholar PubMed
20. Braga, F, Pasqualetti, S, Aloisio, E, Panteghini, M. The internal quality control in the traceability era. Clin Chem Lab Med 2021;59:291–300. https://doi.org/10.1515/cclm-2020-0371.Search in Google Scholar PubMed
21. Magnusson, B, Näykki, T, Hovind, H, Krysell, M, Sahlin, E. Handbook for calculation of measurement uncertainty in environmental laboratories. Nordtest report TR 537 (ed. 4); 2017.Search in Google Scholar
22. Frenkel, R, Farrance, I, Badrick, T. Bias in analytical chemistry: a review of selected procedures for incorporating uncorrected bias into the expanded uncertainty of analytical measurements and a graphical method for evaluating the concordance of reference and test procedures. Clin Chim Acta 2019;495:129–38. https://doi.org/10.1016/j.cca.2019.03.1633.Search in Google Scholar PubMed
23. Braga, F, Pasqualetti, S, Borrillo, F, Capoferri, A, Chibireva, M, Rovegno, L, et al.. Definition and application of performance specifications for measurement uncertainty of 23 common laboratory tests: linking theory to daily practice. Clin Chem Lab Med 2023;61:213–23. https://doi.org/10.1515/cclm-2022-0806.Search in Google Scholar PubMed
24. Clinical and Laboratory Standards Institute (CLSI). Characterization and qualification of commutable references materials for laboratory medicine; approved guideline. Document EP30-A (formerly C53-A). Wayne, PA: Clinical and Laboratory Standards Institute; 2010.Search in Google Scholar
25. Nilsson, G, Budd, JR, Greenberg, N, Delatour, V, Rej, R, Panteghini, M, IFCC Working Group on Commutability, et al.. IFCC working group recommendations for assessing commutability. Part 2: using the difference in bias between a reference material and clinical samples. Clin Chem 2018;64:455–64. https://doi.org/10.1373/clinchem.2017.277541.Search in Google Scholar PubMed PubMed Central
26. Panteghini, M. Traceability as a unique tool to improve standardization in laboratory medicine. Clin Biochem 2009;42:236–40. https://doi.org/10.1016/j.clinbiochem.2008.09.098.Search in Google Scholar PubMed
27. Braga, F, Panteghini, M. Verification of in vitro medical diagnostics (IVD) metrological traceability: responsibilities and strategies. Clin Chim Acta 2014;432:55–61. https://doi.org/10.1016/j.cca.2013.11.022.Search in Google Scholar PubMed
28. Braga, F, Infusino, I, Panteghini, M. Performance criteria for combined uncertainty budget in the implementation of metrological traceability. Clin Chem Lab Med 2015;53:905–12. https://doi.org/10.1515/cclm-2014-1240.Search in Google Scholar PubMed
29. Braga, F, Panteghini, M. Defining permissible limits for the combined uncertainty budget in the implementation of metrological traceability. Clin Biochem 2018;57:7–11. https://doi.org/10.1016/j.clinbiochem.2018.03.007.Search in Google Scholar PubMed
30. Panteghini, M. Implementation of standardization in clinical practice: not always an easy task. Clin Chem Lab Med 2012;50:1237–41. https://doi.org/10.1515/cclm.2011.791.Search in Google Scholar PubMed
31. Infusino, I, Bonora, R, Panteghini, M. Traceability in clinical enzymology. Clin Biochem Rev 2007;28:155–61.Search in Google Scholar
32. Miller, WG, Greenberg, N, Panteghini, M, Budd, JR, Johansen, JV. Guidance on which calibrators in a metrologically traceable calibration hierarchy must be commutable with clinical samples. Clin Chem 2023;69:228–38. https://doi.org/10.1093/clinchem/hvac226.Search in Google Scholar PubMed
33. Braga, F, Panteghini, M. Commutability of reference and control materials: an essential factor for assuring the quality of measurements in laboratory medicine. Clin Chem Lab Med 2019;57:967–73. https://doi.org/10.1515/cclm-2019-0154.Search in Google Scholar PubMed
34. Miller, WG, Budd, J, Greenberg, N, Weykamp, C, Althaus, H, Schimmel, H, et al.. IFCC working group recommendations for correction of bias caused by noncommutability of a certified reference material used in the calibration hierarchy of an end-user measurement procedure. Clin Chem 2020;66:769–78. https://doi.org/10.1093/clinchem/hvaa048.Search in Google Scholar PubMed PubMed Central
35. Guo, Q, Wang, J, Yi, X, Zeng, J, Zhou, W, Zhao, H, et al.. Commutability of reference materials for alkaline phosphatase measurements. Scand J Clin Lab Invest 2020;80:388–94. https://doi.org/10.1080/00365513.2020.1747111.Search in Google Scholar PubMed
36. Alkaline phosphatase 2. For use with Alinity c. Ref. B4T830. September 29021.Search in Google Scholar
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