中国青少年中用于检测结核分枝杆菌感染的管内QuantiFERON-TB Gold Plus检测法的比较评估

Comparative evaluation of QuantiFERON-TB gold in-tube plus for Mycobacterium tuberculosis infection among adolescents in China.

作者信息

Lu Peng, Martinez Leonardo, Xue Hao, Liu Qiao, Ding Xiaoyan, Pan Jingjing, Ding Hui, Lu Wei, Zhu Limei, Wang Jiangming

机构信息

Department of Epidemiology, National Vaccine Innovation Platform, School of Public Health, Nanjing Medical University, Nanjing, Jiangsu Province, PR China.

Department of Chronic Communicable Disease, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, Jiangsu Province, PR China.

出版信息

BMC Public Health. 2025 Feb 25;25(1):778. doi: 10.1186/s12889-025-21954-7.

DOI:10.1186/s12889-025-21954-7

PMID:40001083

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11863680/

Abstract

BACKGROUND

No head-to-head studies have simultaneously compared the performances of QuantiFERON-TB Gold In-Tube (QFT-GIT), QuantiFERON-TB Gold Plus (QFT-Plus), ESAT6-CFP10 (EC) skin test, and Tuberculin skin test (TST) in adolescents. This study aimed to conduct a comparative assessment of QFT-GIT and QFT-Plus for detecting Mycobacterium tuberculosis(Mtb) infection in high school freshmen.

METHODS

We concurrently administered QFT-GIT, QFT-Plus, EC skin test, and TST to first-year high school students. Blood samples were obtained for the QFT-GIT and QFT-Plus assays before the administration of the EC skin test and TST. The diagnostic values were compared. Discrepancies between the tests were quantified using Cohen's kappa coefficient.

RESULTS

A total of 787 freshmen were recruited in this study. Among 787 subjects, EC was positive in 0.8%, TST in 5.3%, QFT-GIT in 1.1%, and QFT-Plus in 3.2%. Overall agreements for QFT-GIT vs. QFT-Plus, QFT-Plus TB1, and QFT-Plus TB2 were 95.7% (95% CI, 94.0-97.0), 97.3% (95% CI, 95.9-98.3), and 95.9% (95% CI, 94.3-97.2), respectively. Cohen's kappa values were 0.485 (95% CI, 0.319-0.621), 0.593 (95% CI, 0.413-0.744), and 0.451 (95% CI, 0.274-0.600). Consistency rates for QFT-GIT, QFT-Plus, EC skin test, and TST were 96.6% (95% CI, 95.0, 97.0), 92.1% (95% CI, 89.0, 94.0), 94.5% (95% CI, 92.6, 96.1), and 91.2% (95% CI, 88.8, 93.1) with Cohen's kappa values of 0.19 (95% CI, -0.01, 0.38), 0.07 (95% CI, -0.02, 0.19), 0.08 (95% CI, -0.01, 0.23), and 0.12 (95% CI, 0.01, 0.21).

CONCLUSION

The QFT-GIT and QFT-Plus assays exhibited a high level of agreement but demonstrated a moderate correlation. IFN-γ levels measured by both QFT-GIT and QFT-Plus were comparable. Notably, Our study suggests QFT-Plus may detect a higher rate of Mtb infection among high school freshmen compared to QFT-GIT, EC skin test, and TST, though this requires cautious interpretation due to the absence of a gold standard for Mtb infection diagnosis.

摘要

背景

尚无对头研究同时比较管内QuantiFERON-TB Gold（QFT-GIT）、QuantiFERON-TB Gold Plus（QFT-Plus）、ESAT6-CFP10（EC）皮肤试验和结核菌素皮肤试验（TST）在青少年中的表现。本研究旨在对QFT-GIT和QFT-Plus在检测高中新生结核分枝杆菌（Mtb）感染方面进行比较评估。

方法

我们同时对高中一年级学生进行QFT-GIT、QFT-Plus、EC皮肤试验和TST。在进行EC皮肤试验和TST之前采集血样用于QFT-GIT和QFT-Plus检测。比较诊断价值。使用科恩kappa系数对检测之间的差异进行量化。

结果

本研究共招募了787名新生。在787名受试者中，EC阳性率为0.8%，TST为5.3%，QFT-GIT为1.1%，QFT-Plus为3.2%。QFT-GIT与QFT-Plus、QFT-Plus TB1和QFT-Plus TB2的总体一致性分别为95.7%（95%CI，94.0 - 97.0）、97.3%（95%CI，95.9 - 98.3）和95.9%（95%CI，94.3 - 97.2）。科恩kappa值分别为0.485（95%CI，0.319 - 0.621）、0.593（95%CI，0.413 - 0.744）和0.451（95%CI，