The value of cross priming amplification test in clinical diagnosis of suspected pulmonary tuberculosis patients

doi:10.3969/j.issn.1000-6621.2018.10.003

Abstract

Abstract:

Objective To evaluate the application value of cross priming amplification (CPA) test in the early clinical diagnosis of pulmonary tuberculosis (PTB). Methods TB suspected patients who went to the 7 TB dispensaries at county or district level in Foshan and Jiangmen cities of Guangdong province from January 2016 to October 2016 were enrolled, a total of 6507 suspected PTB patients were included. All of the recruited patients completed chest X-ray examination and provided sputum samples to perform smear microscopy, solid culture and CPA test, and species identification were performed for culture positive strains. The clinician made diagnosis combining laboratory and clinical examination results, and clinical experts at national level reviewed the initial clinical diagnosis on-site. The proportion of pathogenic positive patients in active PTB was analyzed. Comparison with reviewed clinical diagnosis results was conducted to analyze the sensitivity and specificity of smear microscopy, solid culture and CPA. Results The positive rates of smear microscopy, solid culture and CPA were 18.2% (1187/6507), 25.0% (1629/6507) and 23.9% (1555/6507) respectively. Among 3199 clinically diagnosed patients with active PTB, the positive detection rate of smear combined culture was 48.5% (1550/3199), the positive rate of smear combined with CPA was 47.9% (1531/3199), and that of smear combine culture and CPA was 54.4% (1740/3199). Compared with clinical diagnosis results as the standard, the sensitivities of smear microscopy, solid culture and CPA test for TB detection were 35.0% (1120/3199), 46.4% (1485/3199) and 44.6% (1428/3199) respectively, and the specificities were 98.0% (3241/3308), 95.7% (3164/3308) and 96.2% (3181/3308), respectively. Conclusion TB dispensary at county (district) level can apply CPA test for rapid diagnosis of suspected PTB patients. The combination of multiple diagnostic techniques can significantly increase the pathogen positive rate of active TB patients.

Key words: Tuberculosis, pulmonary, Nucleic acid amplification techniques, Clinical laboratory techniques, Diagnosis, Comparative study

Xi-chao OU,Hai-yan DONG,Hui XIA,Sheng-fen WANG,Yan QU,Bing ZHAO,Zhi-ying ZHANG,Yan-lin ZHAO. The value of cross priming amplification test in clinical diagnosis of suspected pulmonary tuberculosis patients[J]. Chinese Journal of Antituberculosis, 2018, 40(10): 1040-1045. doi: 10.3969/j.issn.1000-6621.2018.10.003

Figures/Tables 4

References 11

[1]	World Health Organization . Global tuberculosis report 2017. Geneva: World Health Organization, 2017.
[2]	Small PM, Pai M . Tuberculosis diagnosis—time for a game change. N Engl J Med, 2010,363(11):1070-1071.
[3]	Xia H, Song YY, Zhao B , et al. Multicentre evaluation of Ziehl-Neelsen and light-emitting diode fluorescence microscopy in China. Int J Tuberc Lung Dis, 2013,17(1):107-112.
[4]	Ou X, Xia H, Li Q , et al. A feasibility study of the Xpert MTB/RIF test at the peripheral level laboratory in China. Int J Infect Dis, 2015,31:41-46. doi: 10.1016/j.ijid.2014.09.011 URL pmid: 25447720
[5]	Pang Y, Xia H, Zhang Z , et al. Multicenter evaluation of genechip for detection of multidrug-resistant Mycobacterium tuberculosis. J Clin Microbiol, 2013,51(6):1707-1713. doi: 10.1128/JCM.03436-12
[6]	Ou X, Song Y, Zhao B , et al. A multicenter study of cross-priming amplification for tuberculosis diagnosis at peripheral level in China. Tuberculosis(Edinb), 2014,94(4):428-433.
[7]	Fang R, Li X, Hu L , et al. Cross-priming amplification for rapid detection of Mycobacterium tuberculosis in sputum specimens. J Clin Microbiol, 2009,47(3):845-847.
[8]	赵雁林, 姜广路 . 痰涂片镜检标准化操作及质量保证手册. 北京: 中国协和医科大学出版社, 2009.
[9]	赵雁林, 王黎霞, 成诗明 , 等. 分枝杆菌分离培养标准化操作程序及质量保证手册.北京: 人民卫生出版社, 2013.
[10]	朱岩昆, 王宇, 靳晓伟 , 等. 交叉引物核酸恒温扩增技术在基层实验室诊断肺结核的应用价值. 中国防痨杂志, 2016,38(10):813-817. doi: 10.3969/j.issn.1000-6621.2016.10.006 URL
[11]	邱勇, 江琦, 李思源 , 等. 县级实验室应用结核分枝杆菌-交叉引物核酸恒温扩增技术检测结果分析. 结核病与肺部健康杂志, 2017,6(4):377-380.

项目点	临床诊断活动性肺结核(例)	涂片+培养		涂片+CPA		涂片+CPA+培养
项目点	临床诊断活动性肺结核(例)	阳性(例)	阳性率(%)	阳性(例)	阳性率(%)	阳性(例)	阳性率(%)
佛山	482	223	46.3	199	41.3	256	53.1
南海	657	317	48.2	357	54.3	383	58.3
三水	354	199	56.2	208	58.8	225	63.6
江门	466	258	55.4	227	48.7	273	58.6
新会	426	152	35.7	141	33.1	154	36.2
开平	159	89	56.0	89	56.0	101	63.5
台山	423	230	54.4	202	47.8	231	54.6
鹤山	95	36	37.9	34	35.8	38	40.0
恩平	137	46	33.6	74	54.0	79	57.7
合计	3199	1550	48.5	1531	47.9	1740	54.4

检测方法	临床诊断(例)		敏感度(%) (95%CI值,%)	特异度(%) (95%CI值,%)	阳性预测值(%) (95%CI值,%)	阴性预测值(%) (95%CI值,%)
检测方法	结核	排除结核	敏感度(%) (95%CI值,%)	特异度(%) (95%CI值,%)	阳性预测值(%) (95%CI值,%)	阴性预测值(%) (95%CI值,%)
涂片镜检			35.0(33.4~33.7)	98.0(97.5~98.5)	94.4(93.0~95.7)	60.9(59.6~62.2)
阳性	1120	67
阴性	2079	3241
固体培养			46.4(44.7~48.1)	95.7(95.0~96.3)	91.2(89.8~92.5)	64.9(63.5~66.2)
阳性	1485	144
阴性	1714	3164
CPA			44.6(42.9~46.4)	96.2(95.5~96.8)	91.8(90.5~93.2)	64.2(62.9~65.6)
阳性	1428	127
阴性	1771	3181

[1]	LIU Xiao-li, LEI Li-mei, GUO Zhou-li, HUANG Yin, XU Jing, ZHAO Xia, WANG Yan, FU Li. Study on the relationship of stigma and social support of tuberculosis patients [J]. Chinese Journal of Antituberculosis, 2020, 42(9): 1002-1008.
[2]	Academic Working Committee of Chinese Antituberculosis Association, Editorial Board of Chinese Journal of Antituberculosis . Expert consensus of clinical application of fixed-dose combination formulations [J]. Chinese Journal of Antituberculosis, 2020, 42(9): 885-893.
[3]	JIN Hong-jian. The construction of tuberculosis prevention and control service system at county level in China needs to be strengthened urgently —— Comments and suggestions of an old tuberculosis control and prevention worker [J]. Chinese Journal of Antituberculosis, 2020, 42(9): 896-902.
[4]	ZHANG Can-you, XIA Hui, CHENG Jun. Testing and reporting requirements for Class Ⅱ biosafety cabinet in tuberculosis laboratory [J]. Chinese Journal of Antituberculosis, 2020, 42(9): 903-909.
[5]	ZHOU Lin, LIU Er-yong, MENG Qing-lin, CHEN Ming-ting, ZHOU Xin-hua, GAO Wei-wei, LIN Ming-gui, XIE Ru-ming. Evaluation of the quality of pulmonary tuberculosis diagnosis after the implementation of the newly revised WS 288-2017 Diagnosis for pulmonary tuberculosis standards [J]. Chinese Journal of Antituberculosis, 2020, 42(9): 910-915.
[6]	LIU Er-yong, WANG Qian, ZHOU Lin, ZHANG Guo-qin, ZHANG Xiu-lei, MA Yong-cheng, YANG Shu-min, WANG Cui, MENG Qing-lin, CHEN Ming-ting, LIN Ming-gui, TU De-hua.. Analysis of diagnostic quality of pulmonary tuberculosis with negative etiology in some areas of China [J]. Chinese Journal of Antituberculosis, 2020, 42(9): 916-920.
[7]	MENG Qing-lin, LI Jin-lan, LIN Ding-wen, MA Yong-cheng, HOU Shuang-yi, LIU Nian-qiang, ZHOU Lin. Analysis of the awareness about knowledge on the updated TB diagnosis standard among the practitioners in TB control institutions [J]. Chinese Journal of Antituberculosis, 2020, 42(9): 921-925.
[8]	WANG Qian, ZHOU Lin, LIU Er-yong, ZHAO Yan-lin, LI Tao, CHEN Ming-ting, YANG Li-jia, WANG Jia.. A survey on the diagnostic ability of tuberculosis in the county-level medical institutions in China [J]. Chinese Journal of Antituberculosis, 2020, 42(9): 926-930.
[9]	LI Ting, HE Jin-ge, SU Qian, LI Jing, LI Yun-kui, GAO Wen-feng, GAO Yuan, YANG Wen. Value of tuberculin test in screening tuberculosis infection in HIV infected/AIDS patients in Butuo County, Sichuan Province [J]. Chinese Journal of Antituberculosis, 2020, 42(9): 931-936.
[10]	LI Yun-kui, HE Jin-ge, SU Qian, LI Ting, LI Jing, GAO Wen-feng, YANG Wen, MAO Guang-yu. Value of tuberculin test in screening tuberculosis infection in HIV infected/AIDS patients in Butuo County, Sichuan Province [J]. Chinese Journal of Antituberculosis, 2020, 42(9): 937-941.
[11]	SU Qian, XIA Yong, LU Jia, WANG Dan-xia, HE Jin-ge. Analysis on the epidemiological characteristics of pulmonary tuberculosis among children aged 0-14 in Sichuan Province from 2009 to 2018 [J]. Chinese Journal of Antituberculosis, 2020, 42(9): 942-947.
[12]	DENG Ya-li, ZHANG Tian-hua, LIU Wei-ping, ZHANG Hong-wei, MA Yu, LI Peng.. Temporal and spatial clustering analysis of pulmonary tuberculosis incidence in Shaanxi Province from 2014 to 2018 [J]. Chinese Journal of Antituberculosis, 2020, 42(9): 948-955.
[13]	DONG Xiao, ZHAO Zhen, LIU Nian-qiang, WANG Sen-lu, CUI Yan. Analysis of the finding characteristics of pulmonary tuberculosis in the elderly population in Xinjiang Uygur Autonomous Region during 2009—2017 [J]. Chinese Journal of Antituberculosis, 2020, 42(9): 956-961.
[14]	LIANG Rui-yun, FANG Wei-jun, REN Hui-li, LI Hui-ru, ZHANG Hui. Study on CT manifestations of non-tuberculous mycobacterium pulmonary disease patients with and without diabetes mellitus [J]. Chinese Journal of Antituberculosis, 2020, 42(9): 962-967.
[15]	MA Ting-long, HAN Yi, CHENG Xu, LIU Zhi-dong. Clinical observation on treatment effectiveness of transdermal ultrasound-mediated drug delivery combined with oral anti-tuberculosis drug in patients with chest wall tuberculosis [J]. Chinese Journal of Antituberculosis, 2020, 42(9): 968-972.