金胺O荧光染色全自动显微扫描识别系统在结核病诊断中的应用价值

doi:10.19982/j.issn.1000-6621.20250412

摘要/Abstract

摘要：

目的：评价金胺O荧光染色全自动显微扫描识别系统（auramine O fluorescence staining automatic microscopic scanning，OF-AS）在结核病诊断中的应用价值。方法：连续纳入2025年1—8月于天津市结核病控制中心门诊部首诊的初诊疑似肺结核患者503例，每例患者留取3份初诊痰液样本，共计1509份。所有痰液样本均完成金胺O荧光染色，阅片检测采用双盲法分别进行传统人工镜检（简称“人工镜检”）和OF-AS，每例患者选取1份质量较好的痰液进行BACTEC MGIT 960分枝杆菌液体培养（简称“MGIT 960培养”），共计完成503例，以MGIT 960培养作为检测肺结核的金标准，分析人工镜检和OF-AS检测肺结核患者痰标本的效能；分析人工镜检和OF-AS检测均为阳性结果的等级相关性。结果：人工镜检的阳性率为12.39%（187/1509），OF-AS的阳性率为11.73%（177/1509），差异无统计学意义（χ²=0.576，P>0.05）。以MGIT 960培养为参考标准，OF-AS检测结核病的敏感度和特异度分别为51.76%（103/199）和95.39%（290/304），略低于人工镜检的敏感度（52.43%，108/206）和特异度（96.97%，288/297），两种诊断方法与金标准的一致性均为中等一致（Kappa值分别为0.529和0.508）。OF-AS与人工镜检结果不一致的痰涂片共54张，主要原因为阅片机漏检和染液沉渣干扰；人工镜检与人工复检结果不一致的痰涂片共8张，均为镜检漏检。结论：OF-AS用于疑似肺结核患者痰液标本检测具有良好的应用价值，其检验性能可满足临床常规金胺O染色查找分枝杆菌的需求。

关键词: 分枝杆菌, 结核；显微镜检查, 荧光；诊断, 鉴别

Abstract:

Objective：To evaluate the application value of a fully automatic auramine O fluorescence staining microscopic scanning system （OF-AS，software recognition） in tuberculosis diagnosis. Methods：A total of 503 consecutive patients with suspected pulmonary tuberculosis who visited the outpatient department of Tianjin Tuberculosis Control Center for the first time from January to August 2025 were enrolled. Three initial sputum specimens were collected from each patient，with a total of 1509 specimens which all were subjected to auramine O fluorescence staining，and then microscopic examination was performed with double-blinded method using traditional manual microscopy （abbreviated as “manual microscopy”） and OF-AS respectively. One sputum specimen of good quality was selected from each patient for BACTEC MGIT 960 mycobacterial liquid culture （abbreviated as “MGIT 960 culture”），with a total of 503 cases completed. Taking MGIT 960 culture as the gold standard for the detection of pulmonary tuberculosis，the efficacies of manual microscopy and OF-AS in testing sputum specimens from patients with pulmonary tuberculosis were analyzed；rank correlation of positive results detected by both manual microscopy and OF-AS was analyzed. Results：The positive rate of manual microscopy （12.39%，187/1509） was higher than that of OF-AS （11.73%，177/1509），but the difference was not statistically significant （χ²=0.576，P>0.05）. Using MGIT 960 culture as the reference standard，the sensitivity and specificity of OF-AS for detecting tuberculosis were 51.76% （103/199） and 95.39% （290/304），respectively，which were slightly lower than those of manual microscopy （sensitivity：52.43%，108/206；specificity：96.97%，288/297）. Both diagnostic methods showed moderate agreement with the gold standard （Kappa values：0.529 and 0.508，respectively）. A total of 54 sputum smears had discordant results between OF-AS and manual microscopy，mainly due to missed detection by the scanner and interference from staining sediment. Eight sputum smears showed discordance between initial manual microscopy and repeated manual microscopy，all attributed to missed detection under microscopy. Conclusion：OF-AS （software recognition） has good application value in testing sputum specimens of suspected pulmonary tuberculosis patients，and its detection performance can meet the requirements of implementing traditional auramine O staining project for detecting mycobacterium.

Key words: Mycobacterium tuberculosis, Microscopy, fluorescence, Diagnosis, differential

中图分类号:

江丽娜, 戴文汐, 巨韩芳, 孟苏凯, 王春花. 金胺O荧光染色全自动显微扫描识别系统在结核病诊断中的应用价值[J]. 中国防痨杂志, 2026, 48(4): 504-509. doi: 10.19982/j.issn.1000-6621.20250412

Jiang Lina, Dai Wenxi, Ju Hanfang, Meng Sukai, Wang Chunhua. Clinical value of auramine O fluorescence staining automatic microscopic scanning and recognition system for detecting tuberculosis[J]. Chinese Journal of Antituberculosis, 2026, 48(4): 504-509. doi: 10.19982/j.issn.1000-6621.20250412

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人工复核	人工镜检						合计
人工复核	N条	+	++	+++	++++	阴性	合计
N条	6	8	0	0	0	6	20
+	22	54	0	0	0	2	78
++	2	3	46	0	0	0	51
+++	0	0	6	17	0	0	23
++++	0	0	0	0	23	0	23
阴性	0	0	0	0	0	1314	1314
合计	30	65	52	17	23	1322	1509

检查方法	MGIT 960培养（份）		敏感度（%，95%CI）	特异度（%，95%CI）	阳性预测值（%，95%CI）	阴性预测值（%，95%CI）	AUC值	Kappa值
检查方法	阳性	阴性	敏感度（%，95%CI）	特异度（%，95%CI）	阳性预测值（%，95%CI）	阴性预测值（%，95%CI）	AUC值	Kappa值
人工镜检			52.43 （70.45~79.42）	96.97 （94.13~98.51）	92.31 （85.50~96.20）	74.61 （69.91~78.82）	0.757	0.529
阳性	108	9
阴性	98	288
OF-AS			51.76 （44.60~58.85）	95.39 （92.22~93.06）	88.03 （80.42~93.06）	75.13 （70.45~79.30）	0.736	0.508
阳性	103	14
阴性	96	290