结核潜伏感染检测方法的研究进展

Progress in the detection of latent tuberculosis infection

  • 摘要:
    目的 分析我国目前主要的3种结核病筛查技术并系统评价其在诊断结核潜伏感染(LTBI)中的准确性,以期为我国的结核病筛查策略制定提供科学的依据和建议。
    方法 通过计算机检索PubMed、中国知网、万方数据库,检索时间为2010年1月1日—2024年8月22日,全面检索结核菌素皮肤试验(TST)、γ⁃干扰素释放试验(IGRA)与重组结核杆菌融合蛋白(EC)皮肤试验诊断LTBI的文献,按照诊断试验的纳入标准筛选文献,提取文献的特征信息。采用Stata 17.0软件进行meta分析,运用随机效应模型对纳入文献予以加权定量合并,计算汇总敏感度、特异度、阳性似然比、阴性似然比及其95%CI。
    结果 共检索到相关文献543篇,最终纳入105篇。其中33篇文献报道了TST的诊断数据,汇总敏感度为0.68(95%CI:0.62~0.73)、特异度为0.67(95%CI:0.60~0.73)、阳性似然比为2.0(95%CI:1.7~2.5)、阴性似然比为0.48(95%CI:0.40~0.58)。94篇文献报道了IGRAs试验的诊断价值,汇总敏感度为0.88(95%CI:0.87~0.89)、特异度为0.82(95%CI:0.79~0.84)、阳性似然比为4.8(95%CI:4.2~5.6)、阴性似然比为0.15(95%CI:0.13~0.17)。EC皮肤试验收集数据较少,但初步分析显示其具有较高的敏感度和特异度。
    结论 IGRA在诊断LTBI方面具有明显的优势。尽管相关数据较少,EC皮肤试验也表现出良好的诊断性能。TST仍然适用于大规模的筛查。

     

    Abstract:
    Objective To introduce the three main techniques for tuberculosis screening currently used in China, to systematically evaluate their accuracy in diagnosing latent tuberculosis infection (LTBI), so as to provide scientific basis and recommendations for the formulation of China’s tuberculosis screening strategy.
    Methods Literature on the diagnosis of tuberculosis by tuberculin skin test (TST), interferon-γ release assay (IGRA), and recombinant Mycobacterium tuberculosis fusion protein (EC) skin test from January 1, 2010 to August 22, 2024 was comprehensively retrieved from PubMed, China National Knowledge Infrastructure (CNKI), and Wanfang Database through computerized search. Besides, all the literature was screened in accordance to the inclusion criteria for diagnostic tests, and characteristic information of the literature selected was extracted simultaneously. Meta-analysis was performed using Stata 17.0 software, with a random-effects model used for weighted quantitative synthesis of included literature, calculating pooled sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, and their 95% confidence intervals (CI).
    Results A total of 543 relevant articles were retrieved, with 105 ultimately included. Among them, 33 articles reported diagnostic data for TST, with a pooled sensitivity of 0.68 (95%CI: 0.62‒0.73), specificity of 0.67 (95%CI: 0.60‒0.73), positive likelihood ratio of 2.0 (95%CI: 1.7‒2.5), and negative likelihood ratio of 0.48 (95%CI: 0.40‒0.58). Ninety-four articles reported the diagnostic value of IGRAs test, with a pooled sensitivity of 0.88 (95%CI: 0.87‒0.89), specificity of 0.82 (95%CI: 0.79‒0.84), positive likelihood ratio of 4.8 (95%CI: 4.2‒5.6), and negative likelihood ratio of 0.15 (95%CI: 0.13‒0.17). Data on EC skin test was limited, but preliminary analysis showed that it had high sensitivity and specificity.
    Conclusion IGRA has a significant advantage in diagnosing LTBI, and EC skin test also shows good diagnostic performance, although relevant data is limited. TST remains suitable for large-scale screening due to its cost-effectiveness.

     

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