Specific detection of tuberculosis infection an interferon-γ-based assay using new antigens

Specific detection of tuberculosis infection an interferon-γ-based assay using new antigens
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DOI:
10.1164/rccm.200402-179oc
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发表时间:
2004-07-01
影响因子:
24.7
通讯作者:
Tsuyuguchi, I
Tsuyuguchi, I
中科院分区:
医学1区
文献类型:
--
作者:
Mori, T;Sakatani, M;Tsuyuguchi, I

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结核菌素皮肤试验用于结核杆菌感染的免疫学诊断有许多局限性,包括被卡介苗(BCG)接种或接触非结核分枝杆菌而混淆。卡介苗和大多数非结核分枝杆菌中不存在的结核分枝杆菌特异性抗原已被鉴定。我们在全血干扰素-伽马试验中检测了其中两种抗原CFP-10和ESAT-6作为卡介苗接种者结核病诊断试验的使用情况。由于缺乏比较结核分枝杆菌感染新检测方法的准确标准,因此,全血干扰素-γ检测的特异性是根据没有确定结核分枝杆菌暴露风险的人(216名接种了卡介苗的日本成年人)的数据估计的,敏感性是根据118名经培养确认的结核分枝杆菌感染患者的数据估计的,这些患者接受治疗不到一周。结合CFP-10和ESAT-6反应,对低风险组的特异度为98.1%,对结核分枝杆菌感染的敏感度为89.0%。结果表明,CFP-10和ESAT-6用于检测结核分枝杆菌感染具有较高的特异性和敏感性,且不受卡介苗接种状态的影响。
The tuberculin skin test for immunologic diagnosis of Mycobacterium tuberculosis infection has many limitations, including being confounded by bacillus Calmette-Guerin (BCG) vaccination or exposure to nontuberculous mycobacteria. M. tuberculosis-specific antigens that are absent from BCG and most nontuberculous mycobacteria have been identified. We examined the use of two of these antigens, CFP-10 and ESAT-6, in a whole blood IFN-gamma assay as a diagnostic test for tuberculosis in BCG-vaccinated individuals. Because of the lack of an accurate standard with which to compare new tests for M. tuberculosis infection, specificity of the whole blood IFN-gamma assay was estimated on the basis of data from people with no identified risk for M. tuberculosis exposure (216 BCG-vaccinated Japanese adults) and sensitivity was estimated on the basis of data from 118 patients with culture-confirmed M. tuberculosis infection who had received less than 1 week of treatment. Using a combination of CFP-10 and ESAT-6 responses, the specificity of the test for the low-risk group was 98.1% and the sensitivity for patients with M. tuberculosis infection was 89.0%. The results demonstrate that the whole blood IFN-gamma assay using CFP-10 and ESAT-6 was highly specific and sensitive for M. tuberculosis infection and was unaffected by BCG vaccination status.