Verification of methotrexate dosage method on Alinity c Abbott automated system in the biochemistry laboratory of CHU Mohammed VI d'Oujda
1 Central Laboratory, Mohammed VI University Hospital, Oujda, Morocco.
2 Faculty of Medicine and Pharmacy of Oujda, Mohammed first university, Morocco.
Research Article
World Journal of Biology Pharmacy and Health Sciences, 2024, 19(02), 261–267.
Article DOI: 10.30574/wjbphs.2024.19.2.0504
Publication history:
Received on 27 June 2024; revised on 09 August 2024; accepted on 12 August 2024
Abstract:
Introduction: This work describes the verification/validation procedure for methotrexate, an anti-metabolite from the antifolate group. Ensuring accurate and reliable measurements is a primary and ongoing concern for biologists in quality management. Based on the recommendations of the technical accreditation guide for human health, SH GTA of COFRAC according to ISO 15189, we performed the verification of a microparticle immunoassay method by chemiluminescence (CMIA) for the quantitative determination of methotrexate in human serum and plasma using the Architect system.
Objectives: The objective of this study was to verify the analytical method for methotrexate determination by assessing key criteria such as repeatability and reproducibility. This verification process aimed to ensure that the method meets the required standards and provides reliable and accurate results in clinical diagnostics.
Results and Discussion: The verification of criteria (repeatability and reproducibility) was conducted using routine patient samples from the CHU and internal and external quality controls. The data were processed using the Middleware EVM validation module.
The study of analytical performance demonstrated that repeatability conformed to the supplier's coefficients of variation (CV) and the data from learned societies (RICOS, SFBC). The results for intra-laboratory reproducibility were very satisfactory for level 1 with a CV of 3.34%, and fairly satisfactory for levels 2 and 3 with CVs of 4.74% and 4.57%, respectively.
Conclusion: In conclusion, the study showed that the results obtained for the different verification criteria of methotrexate measurement on our Alinity ci system are satisfactory when compared to the supplier's data and the standards of learned societies such as SFBC. These results confirm the analytical performance of the method.
Keywords:
Method verification/validation; Repeatability; Reproducibility; Coefficient of variation
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