B-011 Atellica Solution® 和 CI® 分析仪在淀粉酶和葡萄糖方法上的方法间比较验证

IF 7.1 2区医学 Q1 MEDICAL LABORATORY TECHNOLOGY

Clinical chemistry Pub Date : 2024-10-02 DOI:10.1093/clinchem/hvae106.375

S Garcia-Valdecasas, S Lapeña-Garcia, M Ruiz-Alvarez, Y Fernandez-Verduras, T Costales-Lucia, J De La Rubia-Maestu, M Barrionuevo-Gonzalez

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引用次数: 0

摘要

背景本研究的目的是验证两种不同分析仪测量淀粉酶和葡萄糖方法的结果是否可以互换：Atellica Solution® 和 CI® (Siemens Healthineers) 所测量的结果是否可以互换。方法为了对淀粉酶和葡萄糖方法进行方法间比较研究，每种检测方法都选择了 40 份病人样本，样本浓度在整个测量范围内。使用 Method Validator v.19 软件，通过 Bland-Altman 平均差分析和 Passing-Bablok 回归法进行统计分析。统计数据以 95% 的置信区间 (CI) 表示。结果 AMYLASE：在分析了 Bland-Altman 差异后，发现了统计学上显著的系统误差，因为 Atellica Solution® 和 CI® 所获结果的平均差为 28.1，95% CI 不包括空值，CI® 的结果更高。葡萄糖：经过 Bland-Altman 分析，发现存在系统误差，因为 Atellica Solution® 和 CI® 的结果平均相差 2.1，CI® 的结果略高。至于 Passing Bablok 分析，由于截距的置信区间包括零值，因此不存在恒定类型的系统差异，而基于斜率的系统误差比例较小，因为其 95% CI 不包括值 1。结论评估结果后得出的结论是，Atellica Solution® 和 CI® 分析仪在淀粉酶检测方面不能互换，因此应建立新的参考值。至于葡萄糖测定，由于观察到的差异没有超出我们的质量规范，因此两种分析仪可以互换。

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B-011 Intermethod Comparison Verification between Atellica Solution® and CI® Analyzers for Amylase and Glucose Methods

Background The objective of this study is to verify if the results of the Amylase and Glucose methods, measured by two different analyzers: Atellica Solution® and CI® (Siemens Healthineers), are interchangeable. Methods To carry out the intermethod comparison study of the Amylase and Glucose methods, 40 patient samples were selected for each assay, with concentrations across the entire measurement range. Statistical analysis was performed using Method Validator v.19 software, through Bland-Altman mean difference analysis and Passing-Bablok regression. Statistics are expressed with their 95% confidence intervals (CI). Results AMYLASE: After analyzing the Bland-Altman differences, a statistically significant systematic error was found, as the mean difference between the results obtained by Atellica Solution® and CI® was 28.1 with a 95% CI that does not include the null value, with higher results in CI®. Regarding the Passing Bablok analysis, systematic differences, both proportional and constant, were observed as the confidence interval of the intercept does not include the zero value, and that of the slope does not include the value 1.GLUCOSE: After Bland-Altman analysis, a systematic error was found, as the mean difference between the results obtained by Atellica Solution® and CI® was 2.1, with slightly higher results in CI®. Regarding the Passing Bablok analysis, there were no systematic differences of constant type since the confidence interval of the intercept includes the zero value, and a slight proportional systematic error based on the slope as its 95% CI does not include the value 1. Conclusions After evaluating the results, it is concluded that the Atellica Solution® and CI® analyzers are not interchangeable for the Amylase assay, so new reference values should be established. For the Glucose assay, both analyzers are interchangeable as the observed difference does not exceed our quality specification.

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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.