评估 EC-Test 在 HIV 门诊患者中潜伏性结核感染的诊断效果。

Evaluation of the diagnostic efficacy of EC-Test for latent tuberculosis infection in ambulatory people with HIV.

机构信息

Guangxi Key Laboratory of Major Infectious Disease Prevention and Control and Biosafety Emergency Response, Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention, Nanning.

Division of Infectious Diseases, Department of Internal Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing.

出版信息

AIDS. 2023 Oct 1;37(12):1791-1797. doi: 10.1097/QAD.0000000000003573. Epub 2023 Apr 19.

DOI:10.1097/QAD.0000000000003573

PMID:37074384

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10481920/

Abstract

BACKGROUND

Latent tuberculosis infection (LTBI) co-infected with human immunodeficiency virus (HIV) is more likely to develop into active tuberculosis (ATB), recombinant Mycobacterium tuberculosis fusion protein ESAT6/CFP10 (EC-Test) is a latest developed method for LTBI. Compared with the interferon γ release test assays (IGRAs), the diagnostic performance of EC-Test to LTBI screening in HIV needs to be evaluated.

METHODS

A population-based multicenter prospective study was conducted in Guangxi Province, China. The baseline data was collected and LTBI were measured by QuantiFERON-TB Gold In-Tube (QFT-GIT), EC-Test and T-cell spot of the TB assay (T-SPOT.TB).

RESULTS

A total of 1478 patients were enrolled. when taking T-SPOT.TB as reference, the value of sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and consistency that EC-Test to diagnosis LTBI in HIV was 40.42, 97.98, 85.26, 85.04 and 85.06% respectively; when taking QFT-GIT as reference, the value was 36.00, 92.57, 55.10, 85.09 and 81.13%, respectively. When the CD4 + cell count was <200 cells/μl, the accuracies of EC-Test to T-SPOT.TB and QFT-GIT were 87.12 and 88.89%, respectively; when it was 200 ≤ CD4 + ≤ 500 cells/μl, the accuracies of EC-Test was 86.20 and 83.18%, respectively; when the CD4 + cell count >500 cells/μl, the accuracies of EC-Test were 84.29 and 77.94%, respectively. The incidence of adverse reactions in EC-Test was 34.23% and the serious adverse reactions were 1.15%.

CONCLUSION

EC-Test has good consistency compared with IGRAs in detecting LTBI in HIV no matter in different immunosuppression status or different regions, and the safety of EC-Test is also well, suitable for LTBI screening in HIV in high prevalence settings.

摘要

背景

潜伏性结核感染（LTBI）合并人类免疫缺陷病毒（HIV）感染更容易发展为活动性肺结核（ATB），结核分枝杆菌融合蛋白 ESAT6/CFP10（EC-Test）是最新开发的 LTBI 检测方法。与干扰素γ释放试验（IGRAs）相比，EC-Test 对 HIV 人群 LTBI 筛查的诊断性能需要进行评估。

方法

在中国广西进行了一项基于人群的多中心前瞻性研究。收集基线数据，并使用 QuantiFERON-TB Gold In-Tube（QFT-GIT）、EC-Test 和结核感染 T 细胞斑点检测（T-SPOT.TB）测量 LTBI。

结果

共纳入 1478 例患者。以 T-SPOT.TB 为参照，EC-Test 诊断 HIV 人群 LTBI 的灵敏度、特异度、阳性预测值（PPV）、阴性预测值（NPV）和一致性分别为 40.42%、97.98%、85.26%、85.04%和 85.06%；以 QFT-GIT 为参照，分别为 36.00%、92.57%、55.10%、85.09%和 81.13%。当 CD4 + 细胞计数<200 个/μl 时，EC-Test 对 T-SPOT.TB 和 QFT-GIT 的准确度分别为 87.12%和 88.89%；当 200≤CD4 + ≤500 个/μl 时，EC-Test 的准确度分别为 86.20%和 83.18%；当 CD4 + 细胞计数>500 个/μl 时，EC-Test 的准确度分别为 84.29%和 77.94%。EC-Test 的不良反应发生率为 34.23%，严重不良反应发生率为 1.15%。