QuantiFERON-TB Gold Plus试验中TB1和TB2之间的一致性和干扰素γ反应变异性:跨临床亚组的见解

IF 1.5 Q4 INFECTIOUS DISEASES
International Journal of Mycobacteriology Pub Date : 2025-07-01 Epub Date: 2025-09-15 DOI:10.4103/ijmy.ijmy_80_25
Zied Gaifer, Sarah A Alharbi, Lina Alharbi, Hammam Khaled Jafar, Montaha Waleed Demyati, Basmah H Aljehani, Amer Alshengeti
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引用次数: 0

摘要

背景:QuantiFERON-TB Gold Plus (QFT-Plus)检测广泛用于潜伏性结核感染(LTBI)筛查,包括两个抗原管:TB1,刺激表达CD4的T辅助细胞(CD4 + T细胞),TB2,刺激表达CD8的细胞毒性T细胞(CD8 + T细胞)。然而,CD8 +刺激TB2的附加诊断价值仍不确定。本研究旨在评估QFT-Plus检测中TB1和TB2反应的诊断一致性,并评估TB2在检测人口统计学和临床亚组中是否比TB1提供了显著的增量益处。方法:这是一项回顾性研究,纳入了年龄≥14岁的接受QFT-Plus测试的个体。使用Wilcoxon符号秩检验比较TB1和TB2管中干扰素-γ (IFN-γ)的反应。采用Cohen’s kappa系数评价定性一致性。亚组分析按年龄、性别、糖尿病和免疫抑制治疗进行分层。结果:在761名参与者中,TB2组中位IFN-γ反应略高于TB1组(0.21 vs 0.19 IU/mL;中位δ 0.02 IU/mL; P = 0.0002)。这种差异在大多数亚组中是一致的,但很小。TB1与TB2定性结果总体一致性为94.3% (Cohen’s kappa = 0.868)。尽管在肿瘤坏死因子抑制剂的使用者中一致性较低(kappa = 0.582),但在性别、年龄和糖尿病组中一致性仍然很强。没有亚组显示TB2比TB1有临床显著的额外益处。结论:TB2引起的IFN-γ反应略高于TB1,但较小的δ值和高一致性表明在大多数人群中的附加诊断价值有限。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Concordance and Interferon-gamma Response Variability between TB1 and TB2 in the QuantiFERON-TB Gold Plus Assay: Insights Across Clinical Subgroups.

Background: The QuantiFERON-TB Gold Plus (QFT-Plus) assay, widely used for latent tuberculosis infection (LTBI) screening, includes two antigen tubes: TB1, which stimulates T-helper cells expressing CD4 (CD4⁺ T cells), and TB2, which additionally stimulates cytotoxic T cells expressing CD8 (CD8⁺ T cells). However, the added diagnostic value of CD8⁺ stimulation in TB2 remains uncertain. This study aimed to evaluate the diagnostic agreement between TB1 and TB2 responses in the QFT-Plus assay and assess whether TB2 provides a significant incremental benefit over TB1 in detecting tuberculosis infection across demographic and clinical subgroups.

Methods: This was a retrospective study that included individuals aged ≥14 years who underwent QFT-Plus testing. Interferon-gamma (IFN-γ) responses in TB1 and TB2 tubes were compared using the Wilcoxon signed-rank test. Qualitative concordance was assessed using Cohen's kappa coefficient. Subgroup analyses were stratified by age, sex, diabetes, and immunosuppressive therapy.

Results: Among 761 participants, median IFN-γ responses were slightly higher in TB2 than TB1 (0.21 vs. 0.19 IU/mL; median delta 0.02 IU/mL; P = 0.0002). This difference was consistent but small across most subgroups. Overall concordance between TB1 and TB2 qualitative results was 94.3% (Cohen's kappa = 0.868). Agreement remained strong across sex, age, and diabetes groups, though it was lower among users of tumor necrosis factor inhibitors (kappa = 0.582). No subgroup demonstrated a clinically significant added benefit of TB2 over TB1.

Conclusion: TB2 elicited slightly higher IFN-γ responses than TB1, but the small delta values and high concordance suggest limited additional diagnostic value in most populations.

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来源期刊
CiteScore
2.20
自引率
25.00%
发文量
62
审稿时长
7 weeks
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