Centre for Infectious Disease Research and Epidemiology, University of Cape Town, South Africa.
Lancet Infect Dis. 2012 Jan;12(1):45-55. doi: 10.1016/S1473-3099(11)70210-9. Epub 2011 Aug 16.
We aimed to assess whether interferon-γ release assays (IGRAs) can predict the development of active tuberculosis and whether the predictive ability of these tests is better than that of the tuberculin skin test (TST).
Longitudinal studies of the predictive value for active tuberculosis of in-house or commercial IGRAs were identified through searches of PubMed, Embase, Biosis, and Web of Science and complementary manual searches up to June 30, 2011. Eligible studies included adults or children, with or without HIV, who were free of active tuberculosis at study baseline. We summarised incidence rates in forest plots and pooled data with random-effects models when appropriate. We calculated incidence rate ratios (IRR) for rates of disease progression in IGRA-positive versus IGRA-negative individuals.
15 studies had a combined sample size of 26 680 participants. Incidence of tuberculosis during a median follow-up of 4 years (IQR 2-6), even in IGRA-positive individuals, was 4-48 cases per 1000 person-years. Seven studies with no possibility of incorporation bias and reporting baseline stratification on the basis of IGRA results showed a moderate association between positive results and subsequent tuberculosis (pooled unadjusted IRR 2·10, 95% CI 1·42-3·08). Compared with test-negative results, IGRA-positive and TST-positive results were much the same with regard to the risk of tuberculosis (pooled IRR in the five studies that used both was 2·11 [95% CI 1·29-3·46] for IGRA vs 1·60 [0·94-2·72] for TST at the 10 mm cutoff). However, the proportion of IGRA-positive individuals in seven of 11 studies that assessed both IGRAs and TST was generally lower than TST-positive individuals.
Neither IGRAs nor the TST have high accuracy for the prediction of active tuberculosis, although use of IGRAs in some populations might reduce the number of people considered for preventive treatment. Until more predictive biomarkers are identified, existing tests for latent tuberculosis infection should be chosen on the basis of relative specificity in different populations, logistics, cost, and patients' preferences rather than on predictive ability alone.
Special Programme for Research and Training in Tropical Diseases (WHO), Wellcome Trust, Canadian Institutes of Health Research, UK Medical Research Council, and the European and Developing Countries Clinical Trials Partnership.
我们旨在评估干扰素-γ释放试验（IGRAs）是否可预测活动性结核病的发生，以及这些试验的预测能力是否优于结核菌素皮肤试验（TST）。
通过检索 PubMed、Embase、Biosis 和 Web of Science，并辅以截至 2011 年 6 月 30 日的手工检索，我们确定了有关 IGRAs 对活动性结核病的预测价值的纵向研究。合格的研究包括成年人或儿童，无论是否感染 HIV，在研究基线时均无活动性结核病。我们通过森林图汇总发病率，并在适当情况下采用随机效应模型汇总数据。我们计算了 IGRAs 阳性与 IGRAs 阴性个体疾病进展率的发病率比值（IRR）。
15 项研究的合并样本量为 26680 名参与者。在中位数为 4 年（IQR 2-6）的随访期间，即使在 IGRAs 阳性个体中，结核发病率也为每 1000 人年 4-48 例。7 项研究没有合并偏倚的可能性，并根据 IGRAs 结果进行了基线分层报告，显示阳性结果与随后发生结核病之间存在中度关联（汇总未校正的 IRR 2·10，95%CI 1·42-3·08）。与阴性检测结果相比，IGRA 阳性和 TST 阳性结果在结核病风险方面大致相同（在使用这两种方法的 5 项研究中，IGRA 的汇总 IRR 为 2·11[95%CI 1·29-3·46]，TST 为 10mm 截点的 1·60[0·94-2·72]）。然而，在评估 IGRAs 和 TST 的 11 项研究中有 7 项中，IGRA 阳性个体的比例普遍低于 TST 阳性个体。
IGRAs 和 TST 均不能准确预测活动性结核病，尽管在某些人群中使用 IGRAs 可能会减少考虑预防性治疗的人数。在确定更具预测性的生物标志物之前，应根据不同人群中的相对特异性、后勤、成本和患者偏好来选择用于潜伏性结核感染的现有检测方法，而不仅仅是基于预测能力。
热带病研究和培训特别规划署（世卫组织）、惠康信托基金会、加拿大卫生研究院、英国医学研究理事会以及欧洲和发展中国家临床试验伙伴关系。
