Verification of the analytical performance of the serum haptoglobin assay on the Abbott Alinity ci

Loubna Yacoubi, Mouad Harandou, Amina Himri, Zainab Kajeiou, Sabah Mokhtari, Issam Mokhtari, Nisma Douzi, El houcine Sebbar, Mohammed Choukri
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Abstract

Introduction: The aim of our study is to evaluate the haptoglobin assay on the Alinity ci automated system. This evaluation is part of an overall approach to verifying the methods used in the central laboratory of the Mohammed VI University Hospital of Oujda , with a view to compiling an accreditation file in accordance with the requirements of standard NF ISO 15189. Materials and methods: The working methodology adapted by our study is based on the recommendations of the protocol of the COFRAC accreditation technical guide SH GTA 04. Verification involved assessing the repeatability and reproducibility of Alinity ci . Results: The results obtained for the various haptoglobin assay verification criteria show satisfactory repeatability for all three levels, with CV1=1.10%, CV2=0.78% and CV3=1.07% respectively. intra-laboratory reproducibility was satisfactory for all three levels, with CV1=1.79%, CV2= 4.2% and CV3=1.62% respectively. Discussion: Verification of an analytical method is an essential step in guaranteeing that the result obtained is as close as possible to the reference value of a sample. Comparing our results with the CV adopted by the SFBC, we can see that the results are in line with and below the tolerated limits. Conclusion: We can therefore conclude that the Abbott Alinity ci system meets the requirements set by scientific societies for the determination of haptoglobin.
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验证雅培 Alinity ci 血清隐血红蛋白分析仪的分析性能
简介我们的研究旨在对 Alinity ci 自动化系统上的血红蛋白检测方法进行评估。该评估是验证乌季达穆罕默德六世大学医院中心实验室所用方法的整体方法的一部分,目的是根据 NF ISO 15189 标准的要求编制一份认证文件。材料和方法:我们的研究采用的工作方法是基于法国食品和药品委员会认证技术指南 SH GTA 04 协议的建议。验证包括评估 Alinity ci 的可重复性和再现性。结果:对各种血红蛋白检测验证标准的结果显示,所有三个级别的重复性都令人满意,CV1=1.10%,CV2=0.78%,CV3=1.07%。讨论分析方法的验证是保证所得结果尽可能接近样品参考值的重要步骤。将我们的结果与 SFBC 采用的 CV 值进行比较,我们可以看到结果符合并低于容许限度。结论因此,我们可以得出结论:雅培 Alinity ci 系统符合科学协会对测定血红蛋白的要求。
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