Authors :
Hicham Chemsi; Ibrahim Sbai Otmani
Volume/Issue :
Volume 10 - 2025, Issue 5 - May
Google Scholar :
https://tinyurl.com/29a98bnx
DOI :
https://doi.org/10.38124/ijisrt/25may516
Note : A published paper may take 4-5 working days from the publication date to appear in PlumX Metrics, Semantic Scholar, and ResearchGate.
Abstract :
Introduction:
Ferritin is required for the diagnosis of diseases affecting iron metabolism, such as hemochromatosis and iron deficiency
anemia. Verification/validation of the in vitro assay method consists in assessing the performance of the analytical process,
then comparing it with the criteria in NF EN ISO 15189. The aim was to evaluate the analytical performance of the sandwich
chemiluminescence immunometric ferritin assay on a Maglumi® X3 analyzer.
Materials and Methods:
Verification of the ferritin assay on SNIBE's Maglumi® X3 analyzer was based on the methods recommended in the
Valtec protocol and the GTA-SH 04 technical guide for human health accreditation, for assessing the analytical performance
of analyzers for quantitative analysis methods on two different kits from the same batch. The performances tested were
repeatability, reproducibility, and inter-sample contamination. Data were processed using method validation software,
Microsoft Office Excel and SPSS V20 at 5% risk.
Results:
Repeatability quantifying precision and reproducibility quantifying intermediate precision in the first kit were
satisfactory, with CV values of 2.16% and 1.82% respectively for the mean level (CIQ Ferritin Target=58.2 ± 5.83 μg/L). For
the second Kit, the CV values were 0.60% and 1.05% respectively for the same average level. Supplier CVs were in the order
of 3.60% and 5.32%, while SFBC CVs were in the order of 6% and 8% respectively. Inter-sample contamination was deemed
satisfactory for routine use of the analyzer.
Conclusion:
The analyzer tested meets the analytical performance requirements for the reliable determination of ferritin by
sandwich chemiluminescence immunometry on a Maglumi® X3 analyzer.
Keywords :
Ferritin, Reliability, ISO 15189, Immunoassay Verification.
References :
- Vassault A, Grafmeyer D, Graeve J de, Cohen R, Beaudonnet A, Bienvenu J. Analyses de biologie médicale : spécifications et normes d’acceptabilité à l’usage de la validation de techniques. Annales de Biologie Clinique. 1999 ;57(6) :685‑95.
- Document COFRAC SH GTA 04, Guide technique d’accréditation de vérification (portée A) /validation (portée B) des méthodes en Biologie Médicale. 2018
- Document COFRAC SH GTA 14, Guide technique d’accréditation pour l’évaluation des incertitudes de mesure en Biologie Médicale. 2018
- Clark RB, Lewinski MA, Loeffelholz MJ, Tibbetts RJ (2009) Cumitech 31A, Verification and validation of procedures in the clinical microbiology Laboratory. Coordinating ed., Sharp SE, ASM Press, Washington, DC
- CLSI, User Protocol for Evaluation of Quantitative Test Performance; Approved Guideline–second edition, EP12-A2, Vol. 28 No.3, January 2008
- FDA - ORA-LAB.5.4.5. ORA Laboratory Procedure–FDA. Methods, method verification and validation. 2014-08-29 https://www.fda.gov/scienceresearch/fieldscience/laboratorymanual/ucm171877. htm
Introduction:
Ferritin is required for the diagnosis of diseases affecting iron metabolism, such as hemochromatosis and iron deficiency
anemia. Verification/validation of the in vitro assay method consists in assessing the performance of the analytical process,
then comparing it with the criteria in NF EN ISO 15189. The aim was to evaluate the analytical performance of the sandwich
chemiluminescence immunometric ferritin assay on a Maglumi® X3 analyzer.
Materials and Methods:
Verification of the ferritin assay on SNIBE's Maglumi® X3 analyzer was based on the methods recommended in the
Valtec protocol and the GTA-SH 04 technical guide for human health accreditation, for assessing the analytical performance
of analyzers for quantitative analysis methods on two different kits from the same batch. The performances tested were
repeatability, reproducibility, and inter-sample contamination. Data were processed using method validation software,
Microsoft Office Excel and SPSS V20 at 5% risk.
Results:
Repeatability quantifying precision and reproducibility quantifying intermediate precision in the first kit were
satisfactory, with CV values of 2.16% and 1.82% respectively for the mean level (CIQ Ferritin Target=58.2 ± 5.83 μg/L). For
the second Kit, the CV values were 0.60% and 1.05% respectively for the same average level. Supplier CVs were in the order
of 3.60% and 5.32%, while SFBC CVs were in the order of 6% and 8% respectively. Inter-sample contamination was deemed
satisfactory for routine use of the analyzer.
Conclusion:
The analyzer tested meets the analytical performance requirements for the reliable determination of ferritin by
sandwich chemiluminescence immunometry on a Maglumi® X3 analyzer.
Keywords :
Ferritin, Reliability, ISO 15189, Immunoassay Verification.
