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 CH Amphetamines (Amp), Barbiturates (Brb), Benzodiazepine (Bnz), Cannabinoids THC (Thc), Cocaine Metabolite (Coc), Ecstasy (Xtc), Methadone (Mdn), Opiates (Op), Oxycodone (OXY), Phencyclidine (Pcp), and Propoxyphene (Ppx) Assays on the Atellica CI Analyzer. Methods Precision and method comparison (MC) studies were used as performance indicators. Precision studies were performed according to CLSI EP05-A3 using quality control (QC) samples consisting of contrived human urine samples. One aliquot of each QC was tested in duplicate in two runs per day ≥2 hours apart on each analyzer for ≥ 20 days. Precision for each assay was evaluated with one reagent lot on one system. Method comparison studies were performed with three reagent lots according to CLSI EP12-A2. Individual native and contrived human urine samples were analyzed using the Atellica CH Amp, Barb, Bnz, Thc, Coc, Xtc, Mdn, Op, OXY, Pcp, and Ppx Assays on both the Atellica CH and Atellica CI Analyzers. The results were assessed based on analyte values used for distinguishing positive (value ≥cutoff) and negative (value <cutoff) specimens. Results As shown in table below, repeatability and within-lab %CVs based on manufacturer arbitrary units (mAU) were <0.8% and <3.2%, respectively or qualitative interpretation for each replicate remained unchanged for all 80 precision testing measurements (OXY, PcP). Qualitative accuracy assessed by concordance analysis demonstrated ≥95% agreement between the Atellica CI Analyzer and Atellica CH Analyzer. Conclusions Evaluation of the Atellica CH Amp, Barb, Bnz, Thc, Coc, Xtc, Mdn, Op, OXY, Pcp, and Ppx Assays using the Atellica CI Analyzer demonstrated acceptable precision and equivalent performance compared to the same assays on the Atellica CH Analyzer.

中文翻译：

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B-263 Atellica CI 分析仪上十一种滥用药物测定的分析性能评估


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 CH 安非他明 (Amp)、巴比妥类 (Brb)、苯二氮卓类 (Bnz)、大麻素 THC (Thc)、可卡因代谢物 (Coc)、摇头丸 (Xtc)、美沙酮 (Mdn)、阿片类药物 (Op) 的分析性能)、羟考酮 (OXY)、苯环己哌啶 (Pcp) 和丙氧芬 (Ppx) 在 Atellica CI 分析仪上进行测定。方法 精密度和方法比较（MC）研究被用作绩效指标。根据 CLSI EP05-A3，使用由人工尿液样本组成的质量控制 (QC) 样本进行精密度研究。每个 QC 的一份等分试样每天两次在每个分析仪上进行两次测试，间隔≥2 小时，持续≥20 天。每种测定的精确度均通过一个系统上的一批试剂进行评估。根据 CLSI EP12-A2，对三个试剂批次进行了方法比较研究。在 Atellica CH 和 Atellica CI 分析仪上使用 Atellica CH Amp、Barb、Bnz、Thc、Coc、Xtc、Mdn、Op、OXY、Pcp 和 Ppx 检测分析单个天然和人工尿液样本。结果根据用于区分阳性（值≥截止值）和阴性（值<截止值）样本的分析物值进行评估。结果 如下表所示，基于制造商任意单位 (mAU) 的重复性和实验室内 %CV 分别为 <0.8% 和 <3.2%，或者对于所有 80 次精密测试测量，每个重复的定性解释保持不变（氧气，五氯苯酚）。通过一致性分析评估的定性准确性表明，Atellica CI 分析仪和 Atellica CH 分析仪之间的一致性≥95%。 结论 使用 Atellica CI 分析仪对 Atellica CH Amp、Barb、Bnz、Thc、Coc、Xtc、Mdn、Op、OXY、Pcp 和 Ppx 检测进行评估，与在 Atellica CH 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。