Meta-analysis: New tests for the diagnosis of latent tuberculosis infection: Areas of uncertainty and recommendations for research
Meta-analysis: New tests for the diagnosis of latent tuberculosis infection: Areas of uncertainty and recommendations for research
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DOI：
10.7326/0003-4819-146-5-200703060-00006
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发表时间：
2007-03-06
影响因子：
39.2
通讯作者：
Comstock, George
中科院分区：
文献类型：
--
作者：
Menzies, Dick;Pai, Madhukar;Comstock, George
背景资料：直到最近，结核菌素皮肤试验是检测潜伏性结核病（TB）感染的唯一试验，但2种离体干扰素-γ释放试验（IGRA）现已获得商业许可。（QuantiFERON [QFT]和Elispot的商业或研究版本）用于诊断健康和免疫抑制人群中的潜伏性TB感染。作者检索了MEDLINE，并回顾了所有原始文章的引文和英文发表的研究综述。研究选择：研究使用结核分枝杆菌特异性抗原（RD1抗原）和过夜（16至24小时）孵育时间评价了IGRA。数据提取和质量评估：针对灵敏度、特异性和重现性制定了质量评估的具体标准。数据综合：当新诊断的活动性结核病被用作潜伏性结核病感染的替代物时，所有测试的灵敏度都不理想，尽管Elispot的灵敏度更高。没有一种检测方法能区分活动性结核病和潜伏性结核病。结核菌素皮肤试验和IGRA的敏感性在被归类为临床暴露梯度的人中是相似的。QFT和Elispot的合并特异性分别为97.7%（95% CI，96%至99%）和92.5%（CI，86%至99%）。在接种卡介苗的样本中，这两种检测方法的特异性均高于结核菌素皮肤试验。在3项免疫受损样本的研究中，Elispot比结核菌素皮肤试验更敏感。不一致的结核菌素皮肤试验和IGRA反应是频繁的，很大程度上无法解释，虽然有些可能与不同的定义阳性试验结果。IGRA结果从阳性到阴性的逆转是常见的2项研究中，它是assessed.Limitations：大多数研究采用了横截面设计的固有限制，没有金标准的潜伏性结核感染，大多数涉及小样本的真阳性和假阳性的测试结果的可能性相差很大。有足够的证据IGRA的性能在儿童，免疫功能低下的人，和elderized.Conclusions：新的IGRAs显示相当大的承诺，并具有良好的特异性。需要更多的研究来更好地确定它们在高风险人群和系列测试中的性能。需要进行纵向研究来确定IGRA的预测价值。
Background: Until recently, the tuberculin skin test was the only test for detecting latent tuberculosis (TB) infection, but 2 ex vivo interferon-gamma release assays (IGRAs) are now commercially licensed.Purpose: To estimate sensitivity, specificity, and reproducibility of IGRAs (commercial or research versions of QuantiFERON [QFT] and Elispot) for diagnosing latent TB infection in healthy and immune-suppressed persons.Data Sources: The authors searched MEDLINE and reviewed citations of all original articles and reviews for studies published in English.Study Selection: Studies had evaluated IGRAs using Mycobacterium tuberculosis-specific antigens (RD1 antigens) and overnight (16- to 24-h) incubation times. Reference standards had to be clearly defined without knowledge of test results.Data Extraction and Quality Assessment: Specific criteria for quality assessment were developed for sensitivity, specificity, and reproducibility.Data Synthesis: When newly diagnosed active TB was used as a surrogate for latent TB infection, sensitivity of all tests was suboptimal, although it was higher with Elispot. No test distinguishes active TB from latent TB. Sensitivity of the tuberculin skin test and IGRAs was similar in persons who were categorized into clinical gradients of exposure. Pooled specificity was 97.7% (95% CI, 96% to 99%) and 92.5% (CI, 86% to 99%) for QFT and for Elispot, respectively. Both assays were more specific than the tuberculin skin test in samples vaccinated with bacille Calmette-Guerin. Elispot was more sensitive than the tuberculin skin test in 3 studies of immune-compromised samples. Discordant tuberculin skin test and IGRA reactions were frequent and largely unexplained, although some may be related to varied definitions of positive test results. Reversion of IGRA results from positive to negative was common in 2 studies in which it was assessed.Limitations: Most studies used cross-sectional designs with the inherent limitation of no gold standard for latent TB infection, and most involved small samples with a widely varying likelihood of true-positive and false-positive test results. There is insufficient evidence on IGRA performance in children, immune-compromised persons, and the elderly.Conclusions: New IGRAs show considerable promise and have excellent specificity. Additional studies are needed to better define their performance in high-risk populations and in serial testing. Longitudinal studies are needed to define the predictive value of IGRAs.