Expert consensus on the application of Mycobacterium tuberculosis infection detection technologies

doi:10.19982/j.issn.1000-6621.20250231

Abstract

Abstract:

Mycobacterium tuberculosis infection test is an essential method for identifying latent tuberculosis infection and clinically diagnosing tuberculosis. To better guide clinical practice, this consensus was jointly organized by the Tuberculosis Control Branch, Standardization Professional Branch and Elderly Tuberculosis Control Branch of Chinese Antituberculosis Association. Based on domestic and international research progress and clinical practice experiences, and taking into account the specific situations in different scenarios, recommendations on the application of Mycobacterium tuberculosis infection detection technologies are proposed. The consensus provides a detailed introduction to the characteristics and applications of various Mycobacterium tuberculosis infection tests and offers specific suggestions for the selection and application of detection technologies in different application scenarios, such as high-risk populations, key venue populations, and clinical tuberculosis diagnosis. In addition, the application of infection test results in tuberculosis treatment efficacy evaluation is discussed. This consensus aims to provide references for professionals related to tuberculosis prevention and control, diagnosis and treatment in medical and health institutions at all levels and types, in order to help achieve the goal of “ending the TB epidemic”.

Key words: Mycobacterium tuberculosis, Infection, Diagnostic techniques and procedures, Consensus development conferences as topic

CLC Number:

R446
R52

Tuberculosis Control Branch of Chinese Antituberculosis Association, Standardization Professional Branch of Chinese Antituberculosis Association, Elderly Tuberculosis Control Branch of Chinese Antituberculosis Association. Expert consensus on the application of Mycobacterium tuberculosis infection detection technologies[J]. Chinese Journal of Antituberculosis, 2025, 47(7): 813-829. doi: 10.19982/j.issn.1000-6621.20250231

Figures/Tables 1

检测项目检测技术	标本类型	标本量	标本运输	标本保存	检测周期 (h)	安全性	技术特色	是否需要访视检测对象获得检测结果	禁忌证
皮肤试验
结核菌素皮肤试验	-	-	-	-	48~72	安全性良好,常见局部不良反应为注射部位瘙痒和皮疹等,有结核病史或过敏体质者局部可出现水疱或溃疡。通常可自行消退,无需特殊处理,偶有严重者可做局部消炎或退热处理	操作简便、不需要特殊仪器设备;出生一次卡介苗接种史对检测结果影响有限^[26-27];卡介苗加强免疫策略对检测结果存在显著影响	是	患有急性传染病(如麻疹、百日咳、流行性感冒、肺炎等)、急性眼结膜炎、急性中耳炎、广泛性皮肤病患者及过敏体质者
MTB特异抗原皮肤试验	-	-	-	-	48~72	安全性良好,常见局部不良反应为注射部位的瘙痒、肿痛,局部出现水疱、坏死,淋巴管炎者属于强阳性反应,较少见,通常可自行消退,无需特殊处理	操作简单、不需要特殊仪器设备,不受卡介苗接种和多数非结核分枝杆菌感染影响	是	患有急性传染病(如麻疹、百日咳、流行性感冒、肺炎等)、急性眼结膜炎、急性中耳炎、广泛性皮肤病患者及过敏体质者
γ-干扰素释放试验
酶联免疫斑点法	外周静脉血	3.5~ 8ml	短期室温 (18~25℃) 保存与运输	无延长试剂6h内处理完,有延长试剂54h内处理完	16~24	体外检测,风险不大于日常体检造成的风险	不受卡介苗接种和多数非结核分枝杆菌感染影响;标本经洗涤和标化后,检测分析误差较小,在免疫低下、免疫抑制人群中受益明显	否	无
酶联免疫吸附法	外周静脉血	4~ 8ml	短期室温 (18~25℃) 或冷藏 (2~8℃) 保存与运输均可	采血后室温16h内处理样本或采血后2~8℃存放并在48~56h内处理。孵育后的血浆样本4~27℃可放置3d,2~8℃可保存28d。血浆吸出后在-20℃以下能保存更长时间	16~24	体外检测,风险不大于日常体检造成的风险	不受卡介苗接种和多数非结核分枝杆菌感染影响;无需任何细胞提取,全血孵育,可实现样本直接上机到报告的全自动化;软件读取结果	否	无
荧光免疫层析法	外周静脉血	>3ml	短期冷藏 (2~8℃) 保存与运输	采血后16h内处理。孵育后的上清液2~8℃保存24h,-20℃以下可长期保存	24	体外检测,风险不大于日常体检造成的风险	不受卡介苗接种和多数非结核分枝杆菌感染影响;通过搭载荧光扫描分析仪,操作简单,适合基层开展使用	否	无
化学发光法	外周静脉血	>3ml	短期冷藏 (2~8℃) 保存与运输	采血后16h内处理。孵育后的上清液2~8℃保存24h,-20℃以下可长期保存	24	体外检测,风险不大于日常体检造成的风险	不受卡介苗接种和多数非结核分枝杆菌感染影响;不确定样本占比低,自动化操作简便、快捷	否	无
γ-干扰素/白细胞介素2双因子检测
酶联免疫吸附法	外周静脉血	>4ml	短期室温 (18~25℃) 保存与运输	采血后8h内处理。孵育后的上清液室温不超过4h,-20℃以下保存不应超过30d	24	体外检测,风险不大于日常体检造成的风险	不受卡介苗接种和多数非结核分枝杆菌感染影响;无需任何细胞提取,全血孵育,双因子联合检测可提高结核分枝杆菌感染检测敏感度^[22]	否	无
γ-干扰素诱导蛋白10 mRNA表达量检测
PCR荧光探针法	外周静脉血	>3.5ml	短期室温 (18~25℃) 保存与运输	采血后16h内处理,孵育4~6h(或者过夜孵育)后进行核酸提取和扩增。核酸模板可根据需要在2~8℃保存24h或-80℃以下长期保存	6~24	体外检测,风险不大于日常体检造成的风险	不受卡介苗接种和多数非结核分枝杆菌感染影响;检测周期短,结果不易受炎症等本底干扰	否	无

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