抗酸染色全自动显微扫描识别系统的临床应用评价

doi:10.3969/j.issn.1000-6621.2021.10.019

摘要/Abstract

摘要：

目的评价抗酸染色全自动显微扫描系统(AFB-AS)检测肺结核患者痰液标本应用价值。方法搜集2019年1月至8月于北京结核病控制研究所确诊的462例肺结核患者作为研究对象,每例患者留取3份初诊痰液标本,共计1386份。所有标本均完成萋-尼抗酸染色,采用双盲法使用传统抗酸杆菌染色镜检和AFB-AS检查;每例患者选取2份痰液标本进行分枝杆菌分离培养,共计完成924份;其中1份同时进行GeneXpert MTB/RIF(简称“Xpert”)检测,共计完成462份。比较不同方法检测肺结核患者痰标本结果;以分枝杆菌分离培养结果为参照,分析传统抗酸杆菌染色镜检和AFB-AS检测肺结核患者痰标本的效能;分析传统抗酸杆菌染色镜检和AFB-AS检测均为阳性结果的等级相关性。结果各方法检测肺结核患者痰标本阳性率从高到低依次为Xpert(69.26%,320/462)、分枝杆菌分离培养(43.61%,403/924)、AFB-AS(43.22%,599/1386)、传统抗酸杆菌染色镜检(38.24%,530/1386)。AFB-AS检测痰标本阳性率明显高于传统抗酸杆菌染色镜检,差异有统计学意义(χ²=67.015,P<0.01)。AFB-AS与传统抗酸杆菌染色镜检判读阳性结果等级的相关系数为0.954。以分枝杆菌分离培养结果为参照,AFB-AS检查肺结核患者痰标本敏感度为94.29%(380/403)、特异度为90.40%(471/521)、阳性预测值为88.37%(380/430)、阴性预测值为95.34%(471/494),Kappa值为0.841。结论 AFB-AS检测肺结核患者痰液标本具有较好的应用价值,检验性能能够满足实施萋-尼抗酸染色查找抗酸杆菌项目的要求。

关键词: 分枝杆菌, 结核, 染色与标记, 显微镜检查, 自动化

Abstract:

Objective To evaluate the application value of the automatic acid-fast staining microscopic scanning system (AFB-AS) in detecting sputum specimens of pulmonary tuberculosis patients. Methods A total of 462 pulmonary tuberculosis patients diagnosed at the Beijing Tuberculosis Control Institute from January to August 2019 were collected. Each patient retained 3 newly diagnosed sputum samples (n_total=1386). All specimens were stained by Ziehl-Neelsen (ZN) and double-blindly tested by traditional acid-fast bacillus staining microscopy and AFB-AS inspection; 2 sputum samples from each patient were selected for mycobacterial isolation and culture, a total of 924 were completed; the other one of sputum samples was tested by GeneXpert MTB/RIF (Xpert) simultaneously, and a total of 462 samples were completed. The results of different methods for detecting sputum specimens of pulmonary tuberculosis patients were compared. The efficacy of traditional acid-fast bacillus staining microscopy and AFB-AS for detecting sputum specimens of pulmonary tuberculosis patients was analyzed based on the results of mycobacterial isolation and culture, so was the level correlation between the traditional acid-fast bacillus staining microscopic examination and AFB-AS test for positive results. Results The positive rates of sputum specimens of pulmonary tuberculosis patients detected by various methods, from high to low, were Xpert (69.26%, 320/462), mycobacterial isolation and culture (43.61%, 403/924), AFB-AS (43.22%, 599/1386) and traditional acid-fast bacilli staining microscopic examination (38.24%, 530/1386). The positive rate of sputum specimens detected by AFB-AS was significantly higher than that by traditional acid-fast bacilli staining microscopy (χ²=67.015, P<0.01). The correlation coefficient between AFB-AS and traditional acid-fast bacilli staining microscopy to judge the positive result level was 0.954. Taking the results of mycobacterial isolation and culture as the reference, the sensitivity, specificity, positive predictive value and negative predictive value of AFB-AS were 94.29% (380/403), 90.40% (471/521), 88.37% (380/430) and 95.34% (471/494), respectively, and the Kappa value was 0.841. Conclusion AFB-AS has good application value in detecting sputum specimens of pulmonary tuberculosis patients. The inspection performance can meet the requirements of the project of monitoring acid-fast bacilli by Z-N.

Key words: Mycobacterium tuberculosis, Staining and labeling, Microscopy, Automation

丁北川, 周复, 杨新宇, 孟宪杰, 易俊莉, 叶健苗, 武文清. 抗酸染色全自动显微扫描识别系统的临床应用评价[J]. 中国防痨杂志, 2021, 43(10): 1084-1088. doi: 10.3969/j.issn.1000-6621.2021.10.019

DING Bei-chuan, ZHOU Fu, YANG Xin-yu, MENG Xian-jie, YI Jun-li, YE Jian-miao, WU Wen-qing. Evaluation of clinical application of automatic acid-fast staining microscopic scanning system[J]. Chinese Journal of Antituberculosis, 2021, 43(10): 1084-1088. doi: 10.3969/j.issn.1000-6621.2021.10.019

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参考文献 9

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抗酸染色全自动显微扫描系统人工复核	传统抗酸杆菌染色镜检						合计
抗酸染色全自动显微扫描系统人工复核	N条	1+	2+	3+	4+	阴性	合计
N条	12	2	0	0	0	49	63
1+	43	192	4	5	0	20	264
2+	0	4	113	0	0	0	117
3+	0	0	0	105	0	0	105
4+	0	0	0	1	49	0	50
阴性	0	0	0	0	0	787	787
合计	55	198	117	111	49	856	1386

抗酸染色全自动显微扫描系统软件识别	传统抗酸杆菌染色镜检						合计
抗酸染色全自动显微扫描系统软件识别	N条	1+	2+	3+	4+	阴性	合计
N条	5	0	0	0	0	92	97
1+	50	193	4	5	0	81	333
2+	0	5	113	0	0	0	118
3+	0	0	0	105	0	0	105
4+	0	0	0	1	49	0	50
阴性	0	0	0	0	0	683	683
合计	55	198	117	111	49	856	1386

抗酸染色全自动显微扫描系统软件识别	抗酸染色全自动显微扫描系统人工复核						合计
抗酸染色全自动显微扫描系统软件识别	N条	1+	2+	3+	4+	阴性	合计
N条	29	0	0	0	0	68	97
1+	34	263	0	0	0	36	333
2+	0	1	117	0	0	0	118
3+	0	0	0	105	0	0	105
4+	0	0	0	0	50	0	50
阴性	0	0	0	0	0	683	683
合计	63	264	117	105	50	787	1386

检查方法	分枝杆菌分离培养		敏感度 (95%CI,%)	特异度 (95%CI,%)	阳性预测值 (95%CI,%)	阴性预测值 (95%CI,%)	Kappa值
检查方法	阳性(份)	阴性(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,%)	Kappa值
传统抗酸杆菌染色镜检			89.58 (85.73~93.43)	95.59 (93.00~98.18)	94.01 (91.02~97.00)	92.22 (88.85~95.59)	0.856
阳性	361	23
阴性	42	498
抗酸染色全自动显微扫描系统检测			94.29 (91.37~97.21)	90.40 (86.96~94.11)	88.37 (84.33~92.41)	95.34 (92.68~98.00)	0.841
阳性	380	50
阴性	23	471

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