Verification of the analytical performance of the serum anti-thyroperoxidase antibody assay on the Abbott Alinity ci®: Experience from the Biochemistry Laboratory of the Mohammed VI University Hospital of Oujda
1 Mohammed First University, Faculty of Medicine and Pharmacy of Oujda, Morocco.
2 Biochemistry laboratory of Mohammed VI University Hospital, Oujda, Morocco.
Research Article
GSC Biological and Pharmaceutical Sciences, 2025, 30(02), 261-268.
Article DOI: 10.30574/gscbps.2025.30.2.0067
Publication history:
Received on 08 January 2025; revised on 15 February 2025; accepted on 18 February 2025
Abstract:
The objective of this study was to evaluate the analytical performance of the measurement of anti-thyroperoxidase antibodies (anti-TPO antibodies) in human serum and plasma, using chemiluminescent microparticle immunoassay (CMIA), in accordance with Domain A criteria of the medical biology method verification/validation guide.
The results of the anti-TPO antibody serum assays show good repeatability for the three levels (1: low, 2: medium, and 3: high), with respective coefficients of variation (CV) of 1.67%, 1.97%, and 1.17%. Similarly, intermediate precision is considered satisfactory, with CV of 1.90% for level 1, 1.96% for level 2, and 1.38% for level 3. Comparison with the reference CV defined by the RICOS (Reference Institute for Clinical and Healthcare Standards) confirms the reliability and compliance of the results.
The results allowed us to verify the performance of the light chain Lambda assay method and compare it with the analytical objectives set in the accreditation process in which our laboratory is engaged.
Keywords:
Anti-thyroperoxidase antibody assay; Analytical performance; Repeatability; Reproducibility; Coefficient of variation; Alinity ci® analyzer
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Copyright © 2025 Author(s) retain the copyright of this article. This article is published under the terms of the Creative Commons Attribution Liscense 4.0
