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基于C反应蛋白的结核病分类测试:一个多国诊断准确性研究
Brigitta Derendinger1, Tessa K Mochizuki2,3, Danaida Marcelo4
1DSI-NRF Centre of Excellence for Biomedical Tuberculosis Research, SAMRC Centre for Tuberculosis Research, Division of Molecular Biology and Human Genetics, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
概括
结核病 (TB) 的C-反应蛋白 (CRP) 测试在一个多国研究中没有达到准确性目标. 性能因地理区域和参与者小组而异,影响了其作为可靠的结核病选试验的使用.
科学领域:
- 传染性疾病 传染性疾病
- 公共卫生 公共卫生
- 生物标志物 生物标志物
背景情况:
- 推使用C反应蛋白 (CRP) 进行艾滋病毒感染者的结核病 (TB) 查.
- 在没有艾滋病毒的人群中以及在全球不同环境中,CRP对结核病的诊断准确性在很大程度上是未知的.
- 有效的结核病分拣测试对于及时诊断和管理至关重要,特别是在高负担地区.
研究的目的:
- 评估C反应蛋白 (CRP) 对于结核病 (TB) 查的诊断准确性.
- 确定CRP是否符合有效的结核病选试验的最低准确性目标 (灵敏度≥90%,特异性≥70%).
- 评估不同国家,性别和艾滋病毒/糖尿病状况的CRP性能差异.
主要方法:
- 一项涉及多个国家的研究,涉及来自非洲和亚洲五个结核病流行国家的2904名咳 (≥2周) 的门诊患者.
- 使用Xpert MTB/RIF Ultra和培养物进行临床CRP检测,艾滋病毒/糖尿病查和唾液分析.
- 计算了CRP (5 mg/L切割点) 的灵敏度和特异性,并使用ROC回归来对各个子组进行了比较.
主要成果:
- 整体CRP敏感度为84%,特异性为61%,低于目标值.
- 观察到显著的地理差异:非洲 (≥91%) 与亚洲 (64-82%) 国家的敏感性更高.
- 与没有艾滋病毒的人相比,艾滋病毒感染者 (45%) 的特异性较低 (64%);男性对女性的敏感性更高.
结论:
- 在这项多国研究中,CRP没有达到结核病选的最低准确性目标.
- 根据地理位置和参与者小组,包括艾滋病毒状况,表现有很大差异.
- 观察到的变化可能反映了菌根菌群和种群特征的差异.
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