Automated indirect immunofluorescence evaluation of antinuclear autoantibodies on HEp-2 cells.

Automated indirect immunofluorescence evaluation of antinuclear autoantibodies on HEp-2 cells.
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DOI:
10.1155/2012/651058
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发表时间:
2012
影响因子:
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通讯作者:
Stöcker W
Stöcker W
中科院分区:
其他
文献类型:
--
作者:
Voigt J;Krause C;Rohwäder E;Saschenbrecker S;Hahn M;Danckwardt M;Feirer C;Ens K;Fechner K;Barth E;Martinetz T;Stöcker W

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人上皮 (HEp-2) 细胞的间接免疫荧光 (IIF) 被认为是检测抗核自身抗体 (ANA) 的金标准筛选方法。然而,在自动化和标准化方面,它无法跟上诊断实验室使用的大多数其他分析技术的步伐。尽管市场上已经有一些针对IIF孵化的自动化解决方案,但结果评估的自动化仍处于起步阶段。因此,EUROPattern Suite 已被开发为一个全面的自动化处理和解释系统,用于通过基于 HEp-2 细胞的 IIF 进行标准化和高效的 ANA 检测。在这项研究中,对总共 351 份血清的自动模式识别与传统视觉解读进行了比较。在区分阳性样本和阴性样本时,349 份血清的目视评估和自动评估获得了一致的结果(99.4%,kappa = 0.984)。系统没有遗漏 272 个抗体阳性样本,并在 79 个视觉阴性样本中识别出 77 个样本(分析灵敏度/特异性:100%/97.5%)。此外,软件正确识别了 94.0% 的主要抗体模式。由于其性能特征,EUROPattern 可实现快速、客观且经济的 IIF ANA 分析,并有可能减少实验室内和实验室间的变异性。
Indirect immunofluorescence (IIF) on human epithelial (HEp-2) cells is considered as the gold standard screening method for the detection of antinuclear autoantibodies (ANA). However, in terms of automation and standardization, it has not been able to keep pace with most other analytical techniques used in diagnostic laboratories. Although there are already some automation solutions for IIF incubation in the market, the automation of result evaluation is still in its infancy. Therefore, the EUROPattern Suite has been developed as a comprehensive automated processing and interpretation system for standardized and efficient ANA detection by HEp-2 cell-based IIF. In this study, the automated pattern recognition was compared to conventional visual interpretation in a total of 351 sera. In the discrimination of positive from negative samples, concordant results between visual and automated evaluation were obtained for 349 sera (99.4%, kappa = 0.984). The system missed out none of the 272 antibody-positive samples and identified 77 out of 79 visually negative samples (analytical sensitivity/specificity: 100%/97.5%). Moreover, 94.0% of all main antibody patterns were recognized correctly by the software. Owing to its performance characteristics, EUROPattern enables fast, objective, and economic IIF ANA analysis and has the potential to reduce intra- and interlaboratory variability.