B-263 Analytical Performance Evaluation of Eleven Drug of Abuse 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/hvae106.620

S Lewisch, P Gupta, W Varhue, G Arrode-Bruses, J Snyder

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引用次数: 0

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 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.

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B-263 Atellica CI 分析仪上 11 种滥用药物检测的分析性能评估

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 CH 苯丙胺类 (Amp)、巴比妥类 (Brb)、苯二氮卓类 (Bnz)、大麻类四氢大麻酚 (Thc) 的分析性能、在 Atellica CI 分析仪上检测可卡因代谢物 (Coc)、摇头丸 (Xtc)、美沙酮 (Mdn)、阿片类 (Op)、羟考酮 (OXY)、苯环利定 (Pcp) 和丙氧芬 (Ppx)。方法将精密度和方法比较 (MC) 研究作为性能指标。根据 CLSI EP05-A3 标准，使用质量控制 (QC) 样品（包括伪造的人体尿样）进行精密度研究。在每台分析仪上对每份质控品的一份等分样品进行重复检测，每天两次，每次间隔≥2小时，持续≥20天。在一个系统上用一个试剂批次对每种化验的精密度进行评估。根据 CLSI EP12-A2 标准，使用三个试剂批次进行了方法比较研究。在 Atellica CH 分析仪和 Atellica CI 分析仪上使用 Atellica CH Amp、Barb、Bnz、Thc、Coc、Xtc、Mdn、Op、OXY、Pcp 和 Ppx 分析仪分析单个原生和人造人体尿样。结果根据用于区分阳性（值≥临界值）和阴性（值<临界值）标本的分析值进行评估。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%，或者说，在所有 80 项精密检测测量（OXY、PcP）中，每个重复的定性解释保持不变。通过一致性分析评估的定性准确度表明，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 分析进行的评估表明，与 Atellica CH 分析仪上的相同分析相比，Atellica CH Amp、Barb、Bnz、Thc、Coc、Xtc、Mdn、Op、OXY、Pcp 和 Ppx 分析具有可接受的精度和同等性能。

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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.