B-009 验证两种分析仪在测定尿酸和尿素时的结果互换性

IF 7.1 2区医学 Q1 MEDICAL LABORATORY TECHNOLOGY

Clinical chemistry Pub Date : 2024-10-02 DOI:10.1093/clinchem/hvae106.373

S Garcia-Valdecasas, S Lapeña-Garcia, M Ruiz-Alvarez, T Costales-Lucia, J Sanchez-Fuertes, M Barrionuevo-Gonzalez

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引用次数: 0

摘要

背景尿酸和尿素是肾脏病理诊断和治疗中广泛使用的两个参数。我们的实验室使用 Atellica Solution® 分析仪（西门子医疗集团）测定这两项指标。在对西门子的新设备 Atellica CI® 进行验证后，必须确保我们通过 ISO 15189:2012 认证的实验室中结果的互换性。目的评估 Atellica Solution® 和 CI® 分析仪测量尿酸和尿素结果的互换性。方法平行处理尿酸值在 1.3 至 15.2 mg/dL 之间的患者血清样本共 40 份，尿素值在 7 至 142 mg/dL 之间的患者血清样本共 40 份。使用 Passing-Bablok 回归法和 Bland Altman 均值差异分析法（方法验证器 1.19 版）对结果进行统计分析。结果以 95% 的置信区间表示。结果尿酸在对布兰德-阿尔特曼差异进行分析后，发现存在统计学意义上的轻微系统误差，因为 95% CI 不包括 0，CI 1900® 的结果略高。关于 Passing-Bablok 回归分析，没有发现恒定类型的系统误差（因为截距的 95% CI 不包括 0），但观察到一个不明显的显著比例系统误差（斜率的置信区间不包括 1）：尿素：在布兰-阿尔特曼分析中，由于平均差的 95% CI 不包括空值，因此出现了一个不确定的系统误差。在 Passing-Bablok 回归分析中，既没有常量型系统误差（因为截距的 95% CI 包括 0），也没有比例型系统误差（因为斜率的 95% CI 包括 1），这表明两种分析仪之间具有互换性。结论 Atellica Solution® 和 CI® 分析仪获得的尿酸和尿素测定结果是可以互换的，因为在统计上观察到的显著差异在分析和临床上都是不明显的。

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B-009 Verification of Result Interchangeability Between Two Analyzers in the Determination of Uric Acid and Urea

Background Uric acid and urea are two parameters widely used in the diagnosis and management of renal pathology. In our laboratory, they are determined using Atellica Solution® analyzers (Siemens Healthineers). After validating a new Siemens equipment, Atellica CI®, it is essential to ensure result interchangeability in our laboratory accredited by ISO 15189:2012. Objectives evaluate the interchangeability of results for uric acid and urea measured by Atellica Solution® and CI® analyzers. Methods A total of 40 serum samples from patients with uric acid values between 1.3 and 15.2 mg/dL, and another 40 serum samples from patients with urea values between 7 and 142 mg/dL were processed in parallel. Statistical analysis of the results was performed using Passing-Bablok regression and Bland Altman mean difference analysis with Method Validator Version 1.19. Results are expressed with their 95% confidence interval. Results Uric Acid: After analyzing Bland-Altman differences, a statistically significant slight systematic error was found, as the 95% CI does not include 0, with slightly higher results in CI 1900®. Regarding Passing-Bablok regression analysis, there were no systematic errors of constant type (since the 95% CI of the intercept includes 0) but a discreet significant proportional systematic error was observed (the confidence interval of the slope does not include 1).Urea: In Bland-Altman analysis, a discreet systematic error was observed as the 95% CI of the mean difference does not include the null value. Regarding Passing-Bablok regression analysis, there were no systematic errors of constant type (since the 95% CI of the intercept includes 0) or proportional type (since the 95% CI of the slope includes 1), indicating interchangeability between both analyzers. Conclusions The results obtained by both Atellica Solution® and CI® analyzers for uric acid and urea assays are interchangeable since the statistically significant differences observed can be considered analytically and clinically insignificant.

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来源期刊

Clinical chemistry 医学-医学实验技术

CiteScore

11.30

自引率

4.30%

发文量

212

审稿时长

1.7 months

期刊介绍： Clinical Chemistry is a peer-reviewed scientific journal that is the premier publication for the science and practice of clinical laboratory medicine. It was established in 1955 and is associated with the Association for Diagnostics & Laboratory Medicine (ADLM). The journal focuses on laboratory diagnosis and management of patients, and has expanded to include other clinical laboratory disciplines such as genomics, hematology, microbiology, and toxicology. It also publishes articles relevant to clinical specialties including cardiology, endocrinology, gastroenterology, genetics, immunology, infectious diseases, maternal-fetal medicine, neurology, nutrition, oncology, and pediatrics. In addition to original research, editorials, and reviews, Clinical Chemistry features recurring sections such as clinical case studies, perspectives, podcasts, and Q&A articles. It has the highest impact factor among journals of clinical chemistry, laboratory medicine, pathology, analytical chemistry, transfusion medicine, and clinical microbiology. The journal is indexed in databases such as MEDLINE and Web of Science.