Analytical performance evaluation of a new integrated clinical chemistry and immunoassay analyzer

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY Practical Laboratory Medicine Pub Date : 2024-08-01 DOI:10.1016/j.plabm.2024.e00427

Ulla Ruffing, Sabrina Mickeler, Michaela Kraft, Peter Findeisen

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Abstract

Background

Clinical laboratories perform a wide range of tests that are used by healthcare professionals to guide medical decision making. Use of automated analyzers in the clinical laboratory can improve patient care by not only reducing the turn-around-time (TAT) of results but also improving accuracy of the reported results by reducing human error. The aim of this study was to evaluate the performance characteristics of a new automated laboratory instrument, the Atellica® CI Analyzer, Model 1900, over a 3-month period in a European laboratory setting.

Methods

Analytical performance of 17 analytes (13 chemistry and four immunochemistry) was assessed by evaluating repeatability and within-laboratory precision using anonymized remnant serum samples. Method comparison studies were performed on the Atellica CI Analyzer and the Roche cobas® 6000.

Results

Excellent precision was observed with coefficients of variation (CVs) less than 2 % for repeatability and less than 3 % within-laboratory imprecision for most analytes. Comparison of select assays with the cobas 6000 system resulted in correlation coefficients ranging from 0.980 to 1.000.

Conclusion

This is the first reported evaluation of the Atellica CI Analyzer in a clinical laboratory setting. The strong analytical performance of the Atellica CI Analyzer demonstrates that this instrument is suitable for routine clinical use.

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新型集成临床化学和免疫测定分析仪的分析性能评估

背景临床实验室进行各种检验，医护人员利用这些检验来指导医疗决策。在临床实验室中使用自动分析仪不仅能缩短结果的周转时间（TAT），还能通过减少人为错误提高报告结果的准确性，从而改善患者护理。本研究的目的是在欧洲实验室环境中对新型自动实验室仪器 Atellica® CI 分析仪（1900 型）的性能特点进行为期 3 个月的评估。方法使用匿名残留血清样本评估重复性和实验室内精确度，从而评估 17 种分析物（13 种化学和 4 种免疫化学）的分析性能。结果表明，大多数分析物的重复性变异系数（CV）小于2%，实验室内不精密度小于3%，具有极佳的精密度。将某些测定与 cobas 6000 系统进行比较，得出的相关系数从 0.980 到 1.000 不等。Atellica CI 分析仪强大的分析性能表明该仪器适合常规临床使用。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Practical Laboratory Medicine Health Professions-Radiological and Ultrasound Technology

CiteScore

3.50

自引率

0.00%

发文量

审稿时长

7 weeks

期刊介绍： Practical Laboratory Medicine is a high-quality, peer-reviewed, international open-access journal publishing original research, new methods and critical evaluations, case reports and short papers in the fields of clinical chemistry and laboratory medicine. The objective of the journal is to provide practical information of immediate relevance to workers in clinical laboratories. The primary scope of the journal covers clinical chemistry, hematology, molecular biology and genetics relevant to laboratory medicine, microbiology, immunology, therapeutic drug monitoring and toxicology, laboratory management and informatics. We welcome papers which describe critical evaluations of biomarkers and their role in the diagnosis and treatment of clinically significant disease, validation of commercial and in-house IVD methods, method comparisons, interference reports, the development of new reagents and reference materials, reference range studies and regulatory compliance reports. Manuscripts describing the development of new methods applicable to laboratory medicine (including point-of-care testing) are particularly encouraged, even if preliminary or small scale.