用于诊断印度幼儿结核病的新型干扰素-γ检测方法。
Novel interferon-gamma assays for diagnosing tuberculosis in young children in India.
作者信息
Shaikh N, Gupte A, Dharmshale S, Pokkali S, Thakar M, Upadhye V J, Ordonez A A, Kinikar A, Gupte N, Mave V, Kagal A, Gupta A, Lalvani A, Paranjpe R, Bharadwaj R, Jain S K
机构信息
National AIDS Research Institute, Pune, India.
Johns Hopkins Bloomberg School of Public Health, Baltimore, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
出版信息
Int J Tuberc Lung Dis. 2017 Apr 1;21(4):412-419. doi: 10.5588/ijtld.16.0428.
SETTING
The tuberculin skin test (TST) and interferon-gamma release assays (IGRAs) are used as supportive evidence to diagnose active tuberculosis (TB). Novel IGRAs could improve diagnosis, but data are lacking in young children.
DESIGN
Children (age 5 years) with suspected TB were prospectively screened at a tertiary hospital in Pune, India; the children underwent TST, and standard (early secretory antigenic target 6 and culture filtrate protein 10) and enhanced (five additional novel antigens) enzyme-linked immunospot (ELISpot) assays.
RESULTS
Of 313 children (median age 30 months) enrolled, 92% had received bacille Calmette-Guérin vaccination, 53% were malnourished and 9% were coinfected with the human immunodeficiency virus (HIV); 48 (15%) had TB, 128 (41%) did not, and TB could not be ruled out in 137 (44%). The sensitivity of enhanced (45%) and standard (42%) ELISpot assays for diagnosing TB was better than that of TST (20%) (P 0.03); however, enhanced ELISpot was not more sensitive than the standard ELISpot assay (P = 0.50). The specificity of enhanced ELISpot, standard ELISpot and TST was respectively 82% (95%CI 74-89), 88% (95%CI 81-94) and 98% (95%CI 93-100). Rv3879c and Rv3615c, previously reported to be promising antigens, failed to improve the diagnostic performance of the ELISpot assay.
CONCLUSION
The TST and the standard and novel ELISpot assays performed poorly in diagnosing active TB among young children in India.
背景
结核菌素皮肤试验（TST）和干扰素-γ释放试验（IGRAs）被用作诊断活动性结核病（TB）的辅助证据。新型IGRAs可能会改善诊断，但在幼儿中缺乏相关数据。
设计
在印度浦那的一家三级医院对疑似结核病的儿童（年龄≤5岁）进行前瞻性筛查；这些儿童接受了TST以及标准（早期分泌性抗原靶标6和培养滤液蛋白10）和增强型（另外五种新型抗原）酶联免疫斑点（ELISpot）试验。
结果
在纳入的313名儿童（中位年龄30个月）中，92%接受过卡介苗接种，53%营养不良，9%合并感染人类免疫缺陷病毒（HIV）；48名（15%）患有结核病，128名（41%）未患结核病，137名（44%）不能排除结核病。增强型（45%）和标准型（42%）ELISpot试验诊断结核病的敏感性优于TST（20%）（P≤0.03）；然而，增强型ELISpot并不比标准型ELISpot试验更敏感（P = 0.50）。增强型ELISpot、标准型ELISpot和TST的特异性分别为82%（95%CI 74 - 89）、88%（95%CI 81 - 94）和98%（95%CI 93 - 100）。先前报道有前景的抗原Rv3879c和Rv3615c未能提高ELISpot试验的诊断性能。
结论
在印度幼儿中，TST以及标准型和新型ELISpot试验在诊断活动性结核病方面表现不佳。
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