常规环境下基于鲁氏锥虫间接免疫荧光试验的自动化评估的性能分析——优势与不足
Performance analysis of automated evaluation of Crithidia luciliae-based indirect immunofluorescence tests in a routine setting - strengths and weaknesses.
作者信息
Hormann Wymke, Hahn Melanie, Gerlach Stefan, Hochstrate Nicola, Affeldt Kai, Giesen Joyce, Fechner Kai, Damoiseaux Jan G M C
机构信息
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出版信息
Clin Chem Lab Med. 2017 Nov 27;56(1):86-93. doi: 10.1515/cclm-2017-0326.
BACKGROUND
Antibodies directed against dsDNA are a highly specific diagnostic marker for the presence of systemic lupus erythematosus and of particular importance in its diagnosis. To assess anti-dsDNA antibodies, the Crithidia luciliae-based indirect immunofluorescence test (CLIFT) is one of the assays considered to be the best choice. To overcome the drawback of subjective result interpretation that inheres indirect immunofluorescence assays in general, automated systems have been introduced into the market during the last years. Among these systems is the EUROPattern Suite, an advanced automated fluorescence microscope equipped with different software packages, capable of automated pattern interpretation and result suggestion for ANA, ANCA and CLIFT analysis.
METHODS
We analyzed the performance of the EUROPattern Suite with its automated fluorescence interpretation for CLIFT in a routine setting, reflecting the everyday life of a diagnostic laboratory. Three hundred and twelve consecutive samples were collected, sent to the Central Diagnostic Laboratory of the Maastricht University Medical Centre with a request for anti-dsDNA analysis over a period of 7 months.
RESULTS
Agreement between EUROPattern assay analysis and the visual read was 93.3%. Sensitivity and specificity were 94.1% and 93.2%, respectively. The EUROPattern Suite performed reliably and greatly supported result interpretation.
CONCLUSIONS
Automated image acquisition is readily performed and automated image classification gives a reliable recommendation for assay evaluation to the operator. The EUROPattern Suite optimizes workflow and contributes to standardization between different operators or laboratories.
背景
针对双链DNA的抗体是系统性红斑狼疮存在的高度特异性诊断标志物,在其诊断中尤为重要。为了评估抗双链DNA抗体,基于利什曼原虫的间接免疫荧光试验(CLIFT)是被认为是最佳选择的检测方法之一。为了克服一般间接免疫荧光试验中固有的主观结果解读缺点,近年来市场上引入了自动化系统。其中包括EUROPattern Suite,这是一种先进的自动化荧光显微镜,配备不同的软件包,能够对ANA、ANCA和CLIFT分析进行自动化模式解读和结果建议。
方法
我们在常规环境中分析了EUROPattern Suite及其对CLIFT的自动化荧光解读性能,反映了诊断实验室的日常工作。连续收集了312份样本,在7个月的时间里将其送至马斯特里赫特大学医学中心中央诊断实验室,要求进行抗双链DNA分析。
结果
EUROPattern检测分析与目视读数之间的一致性为93.3%。敏感性和特异性分别为94.1%和93.2%。EUROPattern Suite性能可靠,极大地支持了结果解读。
结论
自动化图像采集易于进行,自动化图像分类为操作员提供了可靠的检测评估建议。EUROPattern Suite优化了工作流程,有助于不同操作员或实验室之间的标准化。