A-237 Analytical Performance Evaluation of Cytomegalovirus IgG and Syphilis Assays on the Atellica CI Analyzer

IF 7.1 2区医学 Q1 MEDICAL LABORATORY TECHNOLOGY

Clinical chemistry Pub Date : 2024-10-02 DOI:10.1093/clinchem/hvae106.234

M Quintanilla, B Valdivia, L Halik, G Arrode-Bruses, H Leipold

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Abstract

Background The Atellica® CI Analyzer is an automated, high-throughput integrated chemistry and immunoassay analyzer utilizing both Atellica® CH and Atellica® IM Assays. This study evaluated the analytical performance of the Atellica IM Cytomegalovirus IgG (CMV IgG) and Syphilis (Syph) Assays on the Atellica CI Analyzer. Methods Precision studies were performed according to CLSI EP05-A3 using native and contrived human serum samples. CMV IgG and Syph Assays were evaluated with one reagent lot on two Atellica CI analyzers. One aliquot of each sample was tested in duplicate in two runs per day ≥2 hours apart on each analyzer for ≥20 days. Method comparison studies were performed according to CLSI EP12-A2. Individual native human serum samples were analyzed using the Atellica IM CMV IgG and Syph Assays on the Atellica IM and Atellica CI Analyzers. The results were assessed based on Index values distinguishing reactive (Index ≥cut-off value) and nonreactive (Index <cut-off value) specimens. Results As shown in table below, repeatability and within-lab %CVs for the two assays presented were <3.7% and <7.0%. Negative and positive agreement were 100% for the 111 nonreactive CMV IgG samples and the 169 CMV IgG reactive samples tested. Negative and positive agreement were 100% for the 103 Syph reactive samples and the 126 nonreactive Syph samples tested. Overall clinical agreement between each of the presented assays on the Atellica CI Analyzer and Atellica IM Analyzer was 100%. Conclusions Evaluation of the Atellica IM CMV IgG and Syph Assays using the Atellica CI Analyzer demonstrated acceptable precision and equivalent performance compared to the same assays on the Atellica IM Analyzer.

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A-237 Atellica CI 分析仪上巨细胞病毒 IgG 和梅毒化验的分析性能评估

背景 Atellica® CI 分析仪是一种自动化、高通量的集成化学和免疫分析仪，同时使用 Atellica® CH 和 Atellica® IM 检测试剂盒。本研究评估了 Atellica CI 分析仪上的 Atellica IM 巨细胞病毒 IgG (CMV IgG) 和梅毒 (Syph) 检测试剂盒的分析性能。方法根据 CLSI EP05-A3 标准，使用原生和假人血清样本进行精密度研究。在两台 Atellica CI 分析仪上用一个试剂批次对 CMV IgG 和 Syph 检测进行了评估。每份样品的一份等分试样在每台分析仪上每天重复检测两次，每次间隔≥2 小时，持续≥20 天。方法比较研究根据 CLSI EP12-A2 进行。在 Atellica IM 和 Atellica CI 分析仪上使用 Atellica IM CMV IgG 和 Syph 分析仪分析单个本地人血清样本。结果根据区分有反应（指数≥临界值）和无反应（指数<临界值）标本的指数值进行评估。结果如下表所示，两种检测方法的重复性和实验室内%CV 分别为 3.7% 和 7.0%。在检测的 111 份无反应的 CMV IgG 样品和 169 份有反应的 CMV IgG 样品中，阴性和阳性的一致性均为 100%。103 份 Syph 反应性样本和 126 份未反应的 Syph 样本的阴性和阳性一致率均为 100%。Atellica CI 分析仪和 Atellica IM 分析仪上每种检测方法之间的总体临床一致性均为 100%。结论使用 Atellica CI 分析仪对 Atellica IM CMV IgG 和 Syph 检测法进行的评估表明，与 Atellica IM 分析仪上的相同检测法相比，该检测法具有可接受的精确度和同等的性能。

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

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.