Clinical practice guidelines for early detection of pulmonary tuberculosis in general medical facilities

doi:10.19982/j.issn.1000-6621.20230428

Abstract

Abstract:

The diagnosis delay of pulmonary tuberculosis not only results in aggravation and treatment challenges for patients but also leads to the continuously group spreading of tuberculosis. Early detection in general medical facilities, the main primary diagnosis healthcare contact for pulmonary tuberculosis patients, plays a crucial role in achieving the goal of “End tuberculosis strategy”. The National Center of Medical Quality Control for Respiratory Diseases, Tuberculosis Branch of Chinese Medical Association, Tuberculosis Control Branch of Chinese Antituberculosis Association, and China-Japan Friendship Hospital jointly organized experts to formulate the Clinical practice guidelines for early detection of pulmonary tuberculosis in general medical facilities based on the results of China’s tuberculosis prevention practice and the relevant guidelines of the World Health Organization and supplement relevant research evidence at home and abroad. This guide systematically summarizes the characteristics of different diagnostic techniques for pulmonary tuberculosis and proposes tuberculosis screening strategies for different target populations seeking treatment in comprehensive medical institutions, providing evidence for improving and optimizing early detection of pulmonary tuberculosis in national and regional comprehensive medical institutions.

Key words: Tuberculosis, pulmonary, Hospitals, general, Early diagnosis, Consensus development conferences as topic

CLC Number:

R521

National Center of Medical Quality Control for Respiratory Diseases , Tuberculosis Branch of Chinese Medical Association , Tuberculosis Control Branch of Chinese Antituberculosis Association , China-Japan Friendship Hospital . Clinical practice guidelines for early detection of pulmonary tuberculosis in general medical facilities[J]. Chinese Journal of Antituberculosis, 2024, 46(2): 127-140. doi: 10.19982/j.issn.1000-6621.20230428

Figures/Tables 8

References 86

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检测技术	原理	优点	缺点	敏感度	特异度
涂片显微镜检查	临床标本涂片染色后显微镜下直接寻找、观察病原菌,是结核病诊断和发现传染源的主要手段	对硬件设施要求不高,价格低廉,适合基层开展	敏感度较低;不能区分死菌和活菌,无法开展后续的药物敏感性试验;不能区分结核分枝杆菌和非结核分枝杆菌	32%~97%^[9]	50%~100%^[9]
分枝杆菌培养检测	在人工培养基上分离菌落,或检测分枝杆菌生长的代谢产物来确定目标病原菌,是结核病诊断的金标准	比痰涂片显微镜检查敏感度和特异度高,获得的阳性菌株可以用于后续的菌种鉴定、药物敏感性检测等	报告结果时间长、操作复杂,生物安全风险高,对设备和实验室要求较高	89%(涂阳培阳)^[9];73%(涂阴培阳)^[9]	>99%^[9]
分子生物学检测^a	通过分子扩增手段检测临床标本中特异性的靶标,从而检测是否存在结核分枝杆菌核酸或耐药基因	操作简单、快速、敏感度高、自动化程度高	价格较高,对实验室有特殊要求	GeneXpert MTB/RIF:85%(95%CI:82%~88%)^[10];GeneXpert MTB/RIF Ultra:90%(95%CI:84%~94%)^[10];TB-LAMP:78%(95%CI:71%~83%)^[10];CPA:84%~89%^[11];SAT:66%~88%^[11];PCR:55%~99%^[11?-13]	GeneXpert MTB/RIF:98%(95%CI:97%~98%)^[10];GeneXpert MTB/RIF Ultra:96%(95%CI:93%~98%)^[10];TB-LAMP:98%(95%CI:96%~99%)^[10];CPA:95%~99%^[11];SAT:48%~88%^[11];PCR:71%~99%^[11?-13]

检测技术	原理	优点	缺点	敏感度 (95%CI)	特异度 (95%CI)
结核菌素皮肤试验	一种以结核菌素纯蛋白衍生物作为免疫原的迟发型变态反应的皮肤试验^[15]	操作简单,敏感度高,无需实验室与特殊设备辅助,适用于各种环境	不能区分活动性结核病、结核分枝杆菌潜伏感染、接种卡介苗引起的致敏反应,以及非结核分枝杆菌感染引起的交叉反应;注射方式及48~72h的判读方式影响便利性	82%(72%~ 88%)^[16]	93%(90%~ 95%)^[17]
结核分枝杆菌特异抗原皮肤试验	一种以早期分泌抗原靶6和培养滤液蛋白10等结核分枝杆菌蛋白作为变态反应原用于结核分枝杆菌感染检测的新型皮肤试验^[15]	不受卡介苗接种影响,较少受到非结核分枝杆菌感染的影响	不能区分活动性结核病和结核分枝杆菌潜伏感染;注射方式及48~72h的判读方式影响便利性;价格较高	78%(70%~ 84%)^[16]	98%(94%~ 99%)^[17]
γ-干扰素释放试验	采用结核分枝杆菌蛋白质的多肽抗原刺激效应T淋巴细胞分泌γ-干扰素以检测并定量分析γ-干扰素浓度	不受卡介苗接种影响,较少受到非结核分枝杆菌感染的影响,体外检测便利性高	不能区分活动性结核病和结核分枝杆菌潜伏感染;价格较高;对实验室有一定要求	77%(66%~ 85%)^[16]	99%(80%~ 100%)^[17]