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.

中文翻译：

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A-237 Atellica CI 分析仪上巨细胞病毒 IgG 和梅毒检测的分析性能评估


背景 Atellica® CI 分析仪是一款自动化、高通量集成化学和免疫分析仪，同时采用 Atellica® CH 和 Atellica® IM 检测。本研究评估了 Atellica CI 分析仪上 Atellica IM 巨细胞病毒 IgG (CMV IgG) 和梅毒 (Syph) 检测的分析性能。方法 根据 CLSI EP05-A3 使用天然和人工的人血清样本进行精密研究。 CMV IgG 和 Syph 检测在两台 Atellica CI 分析仪上使用一批试剂进行评估。每个样品的一份等分试样在每个分析仪上每天两次运行两次，间隔≥2 小时，持续≥20 天。根据 CLSI EP12-A2 进行方法比较研究。使用 Atellica IM CMV IgG 和 Syph Assays 在 Atellica IM 和 Atellica CI 分析仪上分析单个天然人血清样品。结果根据区分反应性（指数≥截止值）和非反应性（指数％3C截止值）样本的指数值进行评估。结果 如下表所示，两种检测的重复性和实验室内 %CV 分别为 <3.7% 和 <7.0%。所测试的 111 个非反应性 CMV IgG 样本和 169 个 CMV IgG 反应性样本的阴性和阳性一致性为 100%。测试的 103 个梅毒反应性样本和 126 个非反应性梅毒样本的阴性和阳性一致性为 100%。 Atellica CI 分析仪和 Atellica IM 分析仪上提出的各项测定之间的总体临床一致性为 100%。结论 使用 Atellica CI 分析仪对 Atellica IM CMV IgG 和 Syph 检测进行评估，与在 Atellica IM 分析仪上进行的相同检测相比，显示出可接受的精度和相当的性能。