抗酸染色全自动显微扫描识别系统的临床应用评价  

Evaluation of clinical application of automatic acid-fast staining microscopic scanning system

作　　者：丁北川[1] 周复 杨新宇[1] 孟宪杰 易俊莉[1] 叶健苗 武文清[1] DING Bei-chuan;ZHOU Fu;YANG Xin-yu;MENG Xian-jie;YI Jun-li;YE Jian-miao;WU Wen-qing(Beijing Institute of Tuberculosis Control,Bejjing 100035,China)

机构地区：[1]北京结核病控制研究所,100035 [2]杭州上池科技有限公司 [3]北京市西城区疾病预防控制中心结核病预防控制中心

出　　处：《中国防痨杂志》2021年第10期1084-1088,共5页Chinese Journal of Antituberculosis

基　　金：“十三五”国家科技重大专项(2018ZX10103001)。

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(χ^(2)=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。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(ntotal=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(χ^(2)=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 va

关 键 词：分枝杆菌 结核 染色与标记 显微镜检查 自动化 

分 类 号：R446.1[医药卫生—诊断学]