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Validation of metrological traceability of the new generation of Abbott Alinity alkaline phosphatase assay

  • Giorgia Bianchi EMAIL logo , Erika Frusciante , Giulia Colombo ORCID logo , Ilenia Infusino , Elena Aloisio ORCID logo and Mauro Panteghini
Published/Copyright: August 25, 2023
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 62 Issue 2

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.

Keywords: alkaline phosphatase; measurement uncertainty; metrological traceability; standardization; trueness
Corresponding author: Dr. Giorgia Bianchi, Clinical Pathology Unit, ASST Fatebenefratelli-Sacco, via G.B. Grassi 74, 20157, Milan, Italy, Phone: +39 02 39042683, E-mail:

  1. Research ethics: Not applicable.

  2. Informed consent: Not applicable.

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

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

  5. Research funding: None declared.

  6. Data availability: Not applicable.

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Received: 2023-05-25
Accepted: 2023-08-06
Published Online: 2023-08-25
Published in Print: 2024-01-26

© 2023 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2023-0553
Keywords for this article
alkaline phosphatase; measurement uncertainty; metrological traceability; standardization; trueness

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Rapid rule-in and rule-out protocols of acute myocardial infarction using hs-cTnI and hs-cTnT methods
  4. Reviews
  5. A guide to conducting systematic reviews of clinical laboratory tests
  6. Improving diagnosis and treatment of hypomagnesemia
  7. Opininon Paper
  8. Documenting and validating metrological traceability of serum alanine aminotransferase measurements: a priority for medical laboratory community for providing high quality service in hepatology
  9. EFLM Paper
  10. Assessing the status of European laboratories in evaluating biomarkers for chronic kidney diseases (CKD) and recommendations for improvement: insights from the 2022 EFLM Task Group on CKD survey
  11. General Clinical Chemistry and Laboratory Medicine
  12. Bland and Altman agreement method: to plot differences against means or differences against standard? An endless tale?
  13. Assessment of three equations to calculate plasma LDL cholesterol concentration in fasting and non-fasting hypertriglyceridemic patients
  14. Validation of metrological traceability of the new generation of Abbott Alinity alkaline phosphatase assay
  15. Quality assurance programs for vitamin A and E in serum: are we doing enough to assess laboratory performance?
  16. A supervised machine-learning approach for the efficient development of a multi method (LC-MS) for a large number of drugs and subsets thereof: focus on oral antitumor agents
  17. Performance evaluation of alternate ESR measurement method using BC-780 automated hematology analyzer: a comparison study with the Westergren reference method
  18. Total error in lymphocyte subpopulations by flow cytometry-based in state of the art using Spanish EQAS data
  19. Development and multi-center validation of a fully automated digital immunoassay for neurofilament light chain: toward a clinical blood test for neuronal injury
  20. CSF and plasma Aβ42/40 across Alzheimer’s disease continuum: comparison of two ultrasensitive Simoa® assays targeting distinct amyloid regions
  21. Improving regional medical laboratory center report quality through a report recall management system
  22. Cardiovascular Diseases
  23. Evaluation of the analytical and clinical performance of a new high-sensitivity cardiac troponin I assay: hs-cTnI (CLIA) assay
  24. Hemodialysis and biomarkers of myocardial infarction – a cohort study
  25. Letters to the Editor
  26. Chatbot GPT can be grossly inaccurate
  27. Blood collection in heparin vs. EDTA results in an inflammasome-independent increase in monocyte distribution width at 4 h
  28. Week-to-week within-subject and between-subject biological variation of copeptin
  29. The effect of unintended shortage in technical resources on the quality of endpoint clinical laboratory diagnosis
  30. Epigenetic signatures of cfDNA enable a topological assignment of tissue damage
  31. Six Sigma driven QC in antibody testing for infectious diseases
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