Automated antinuclear immunofluorescence antibody analysis is a reliable approach in routine clinical laboratories
Automated antinuclear immunofluorescence antibody analysis is a reliable approach in routine clinical laboratories
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自动化抗核免疫荧光抗体分析是常规临床实验室的可靠方法
DOI：
10.1515/cclm-2017-0050
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发表时间：
2017-10
影响因子：
6.8
通讯作者：
Li Min
中科院分区：
文献类型：
--
作者：
Zheng Bing;Li Enling;Zhu Haoming;Lu Jingbo;Shi Xinming;Zhang Jie;Li Min
摘要背景：间接免疫荧光法（IIF）被推荐为检测抗核抗体（ANA）的金标准方法。本研究旨在探讨自动化系统的可靠性。方法：我们比较了使用NOVA View存档图像的3745份血清样本与通过显微镜进行手动分析。建立了自定义临界值以区分ANA滴度，并在两个临床实验室进行了验证。对ANA自动模式识别系统进行了评价，并对所有ANA阳性血清进行了两种商品化ANA IIF试剂盒，以比较模式判读结果的一致性。对于不一致的模式，使用第三个ANA IIF检测试剂盒。结果：NOVA View平台与手工镜检结果一致率为96.9%。根据1390份血清样本计算了区分ANA四种主要模式滴度的局部临界值。在我们的实验室中，滴度预测准确度上级优于NOVA View中的预设临界值（p<0.01）;另一个实验室的性能相似（p=0.11）。斑点、均匀、着丝粒、核仁和核点模式的自动识别准确率分别为62.7%、57.4%、92.6%、30.5%和27.3%。INOVA和MBL试剂盒的模式判读结果一致性为95.3%。结论：建立个性化增值ANA报告是必要的。然而，由专业技术人员确认数字免疫荧光图像是必不可少的，ANA模式的可疑结果应通过另一种商业ANA IIF试剂盒重新确认，以获得更可靠的结果。
Abstract Background: Indirect immunofluorescence (IIF) assays are recommended as the gold standard method for the detection of antinuclear antibodies (ANAs). This study aimed to investigate the reliability of an automated system. Methods: We compared 3745 serum samples using NOVA View archived images with manual analysis via microscopy. A custom cutoff value was established to distinguish ANA titers and was validated in two clinical laboratories. The automatic ANA pattern recognition system was evaluated, and all ANA-positive sera were subjected to two commercial ANA IIF kits to compare the consistency of the pattern interpretation results. For inconsistent patterns, a third ANA IIF testing kit was utilized. Results: Agreement of the interpretation of the ANA IIF test using the platform of NOVA View and manual microscopy was 96.9%. The local cutoff value to discriminate ANA titers in four main ANA patterns was calculated based on 1390 serum samples. In our laboratory, the titer prediction accuracy was superior to the preset cutoff in NOVA View (p<0.01); the performance was similar in another laboratory (p=0.11). The automatic pattern recognition accuracies of speckled, homogeneous, centromere, nucleolar and nuclear dot patterns were 62.7%, 57.4%, 92.6%, 30.5% and 27.3%, respectively. The consistency of the pattern interpretation results between INOVA and MBL kits was 95.3%. Conclusions: It is necessary to establish a custom value-added ANA report. However, confirmation of the digital immunofluorescence images by expert technicians was essential, and suspect results of an ANA pattern should be reconfirmed by another commercial ANA IIF kit to achieve more reliable results.
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影响因子：
4.1
作者：
Copple SS;Jaskowski TD;Giles R;Hill HR
通讯作者：
Hill HR
影响因子：
2.6
作者：
Bach-Nga Pham;S. Albarède;A. Guyard;E. Burg;Pascale Maisonneuve
通讯作者：
Bach-Nga Pham;S. Albarède;A. Guyard;E. Burg;Pascale Maisonneuve
影响因子：
3.5
作者：
R. Tozzoli;N. Bizzaro;E. Tonutti;D. Villalta;D. Bassetti;F. Manoni;A. Piazza;M. Pradella;P. Rizzotti
通讯作者：
R. Tozzoli;N. Bizzaro;E. Tonutti;D. Villalta;D. Bassetti;F. Manoni;A. Piazza;M. Pradella;P. Rizzotti
影响因子：
4.4
作者：
O. Shovman;N. Agmon-Levin;B. Gilburd;T. Martins;A. Petzold;T. Matthias;Yehuda Shoenfeld
通讯作者：
O. Shovman;N. Agmon-Levin;B. Gilburd;T. Martins;A. Petzold;T. Matthias;Yehuda Shoenfeld
影响因子：
13.6
作者：
Hiemann, Rico;Buettner, Thomas;Conrad, Karsten
通讯作者：
Conrad, Karsten