The Diagnostic Value of Interleukin-2 and Interferon-γ Induced by Fusion Protein (ESAT-6/CFP-10/Rv1985c) for Active Mycobacterium tuberculosis Infection

IF 2.6 4区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Journal of Clinical Laboratory Analysis Pub Date : 2025-02-28 DOI:10.1002/jcla.70010

Zhipeng Zhao, Runqing Li, Xiuying Zhao, Yujie Wang, Minggui Lin, Qian Wei, Xiaochen Li, Pan Xiong

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Abstract

Objective

This study aimed to evaluate the diagnostic ability of interleukin 2 (IL-2) and interferon gamma (IFN-γ) release assay induced by the fusion protein (ESAT-6/CFP-10/Rv1985c) for detecting active tuberculosis (ATB) in clinically visiting patients.

Methods

A total of 970 subjects (215 in ATB group and 755 in non-ATB group) underwent both an interferon-γ release assay (IGRA) and a TB-DNA PCR assay. Using clinical diagnosis as the gold standard, both qualitative and quantitative test results for IL-2 and IFN-γ were analyzed. Subsequently, the diagnostic ability of IL-2 and IFN-γ to screen for ATB among the high-risk population was then evaluated.

Results

IL-2 exhibited higher specificity, while IFN-γ demonstrated higher sensitivity in distinguishing between ATB and non-ATB subjects. The sensitivity of the serial application of IL-2 and IFN-γ had no significant difference (p = 1.000) compared with IFN-γ; the specificity of the serial application of IL-2 and IFN-γ had no significant difference (p = 0.708) compared with IL-2. Quantitative analysis of the results revealed that the IL-2 and IFN-γ values were significantly higher in the ATB group compared with the non-ATB group. Additionally, the combined predictors of IL-2 and IFN-γ did not show a significant difference compared with IL-2 alone (p = 0.324) or IFN-γ alone (p = 0.405).

Conclusions

This study demonstrated that IL-2 and IFN-γ release assays induced by the fusion protein (ESAT-6/CFP-10/Rv1985c) were valuable for distinguishing ATB from non-ATB subjects, with IL-2 exhibiting higher specificity and IFN-γ demonstrating higher sensitivity.

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研究目的本研究旨在评估由融合蛋白（ESAT-6/CFP-10/Rv1985c）诱导的白细胞介素2（IL-2）和γ干扰素（IFN-γ）释放检测对临床就诊患者活动性结核病（ATB）的诊断能力：共有 970 名受试者（ATB 组 215 人，非 ATB 组 755 人）接受了干扰素-γ 释放检测（IGRA）和 TB-DNA PCR 检测。以临床诊断为金标准，对 IL-2 和 IFN-γ 的定性和定量检测结果进行了分析。随后，对 IL-2 和 IFN-γ 在高危人群中筛查 ATB 的诊断能力进行了评估：结果：IL-2表现出更高的特异性，而IFN-γ在区分ATB和非ATB受试者方面表现出更高的灵敏度。连续应用 IL-2 和 IFN-γ 与 IFN-γ 相比，敏感性无显著差异（p = 1.000）；连续应用 IL-2 和 IFN-γ 与 IL-2 相比，特异性无显著差异（p = 0.708）。定量分析结果显示，ATB 组的 IL-2 和 IFN-γ 值明显高于非 ATB 组。此外，IL-2和IFN-γ的综合预测值与单独的IL-2（P = 0.324）或单独的IFN-γ（P = 0.405）相比没有显著差异：本研究表明，融合蛋白（ESAT-6/CFP-10/Rv1985c）诱导的IL-2和IFN-γ释放测定对区分ATB和非ATB受试者很有价值，其中IL-2表现出更高的特异性，IFN-γ表现出更高的敏感性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Clinical Laboratory Analysis 医学-医学实验技术

CiteScore

5.60

自引率

7.40%

发文量

584

审稿时长

6-12 weeks

期刊介绍： Journal of Clinical Laboratory Analysis publishes original articles on newly developing modes of technology and laboratory assays, with emphasis on their application in current and future clinical laboratory testing. This includes reports from the following fields: immunochemistry and toxicology, hematology and hematopathology, immunopathology, molecular diagnostics, microbiology, genetic testing, immunohematology, and clinical chemistry.