与健康人群中的结核素皮肤测试相比,ESAT6-CFP10皮肤测试的准确性:一种随机,盲目,并行控制的III期临床研究
Xiaoyan Ding1, Weixin Du2, Qiao Liu1
1Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, Jiangsu Province, PR China.
BMC infectious diseases
|December 30, 2024
概括
皮肤试验ESAT6-CFP10 (EC) 显示了与健康个体T-SPOT相比的诊断性能,不受BCG疫苗接种的影响. 助推效应与T-SPOT阳性或60岁以上的年龄有关.
科学领域:
- 免疫学 免疫学 免疫学
- 传染性疾病 传染性疾病
- 诊断测试 诊断测试 诊断测试
背景情况:
- 结核病 (TB) 的诊断依赖于敏感和特定的测试.
- 皮肤测试ESAT6-CFP10 (EC) 是一个新的结核病诊断工具.
- 在健康人群中评估EC皮肤测试的性能至关重要.
研究的目的:
- 在健康人群中评估EC皮肤测试的诊断性能.
- 确定影响EC皮肤测试增强效应的因素.
- 为了比较EC皮肤测试的疗效与T-SPOT和TB-PPD测试.
主要方法:
- 一个随机,双盲,并行控制的试验分两个阶段进行.
- 参与者接受了T-SPOT,TB-PPD和EC皮肤测试.
- 第二阶段评估了BCG疫苗接种对初始阴性结果的参与者皮肤测试疗效的影响.
主要成果:
- 在第一阶段,EC皮肤测试阳性率为10.37%,在第二阶段根据BCG疫苗接种而有所变化.
- 在EC和T-SPOT测试之间一致性很高 (88.97%在第一阶段,>91%在第二阶段).
- 年龄≥60岁和T-SPOT重复测试阳性是EC增强效应的重要因素.
结论:
- 在健康个体中,EC皮肤测试显示了类似于T-SPOT的诊断性能.
- 接种BCG疫苗并没有影响EC皮肤测试的有效性.
- 欧洲共同体皮肤测试是一种可靠的诊断工具,其增强效应受特定的人口和免疫学因素的影响.
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