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结核菌素皮肤试验在结核病检测中的作用有多大:通过一项大型突尼斯病例对照研究评估诊断准确性指标。

How useful is the tuberculin skin test for tuberculosis detection: Assessing diagnostic accuracy metrics through a large Tunisian case-control study.

机构信息

Faculty of Medicine of Tunis, Tunis, Tunisia.

出版信息

F1000Res. 2024 Jul 1;12:1297. doi: 10.12688/f1000research.138211.2. eCollection 2023.

Abstract

BACKGROUND AND AIM

During the past decade, the frequency of extrapulmonary forms of tuberculosis (TB) has increased. These forms are often miss-diagnosed. This statement of the TB epidemiological profile modification, conduct us to reflect about the utility of the Tuberculin Skin Test (TST) in active TB detection. This study aimed to evaluate the diagnostic accuracy performance of the TST for active tuberculosis detection.

METHODS

This was a case-control, multicenter study conducted in 11 anti-TB centers in Tunisia (June-November2014). The cases were adults aged between 18 and 55 years with newly diagnosed and confirmed tuberculosis. Controls were free from tuberculosis. A data collection sheet was filled out and a TST was performed for each participant.Diagnostic accuracy measures of TST were estimated using Receiver Operating Curve (ROC) curve and Area Under Curve (AUC) to estimate sensitivity and specificity of a determined cut-off point.

RESULTS

Overall, 1050 patients were enrolled, composed of 336 cases and 714 controls. The mean age was 38.3±11.8 years for cases and 33.6±11 years for controls.The mean diameter of the TST induration was significantly higher among cases than controls (13.7mm vs.6.2mm; p=10 ). AUC was 0.789 [95% CI: 0.758-0.819; p=0.01], corresponding to a moderate discriminating performance for this test. The most discriminative cut-off value of the TST, which was associated with the best sensitivity (73.7%) and specificity (76.6%) couple was   ≥ 11 mm with a Youden index of 0.503. Positive and Negative predictive values were 3.11% and 99.52%, respectively.

CONCLUSIONS

TST could be a useful tool used for active tuberculosis detection, with a moderate global performance and accepted sensitivity and specificity at the cut-off point of 11 mm. However, it cannot be considered as a gold standard test due to its multiple disadvantages.

摘要

背景和目的

在过去的十年中,肺外形式的结核病(TB)的频率增加。这些形式往往误诊。这一TB 流行病学特征变化的陈述,使我们反思结核菌素皮肤试验(TST)在活动性 TB 检测中的效用。本研究旨在评估 TST 对活动性肺结核检测的诊断准确性。

方法

这是一项病例对照、多中心研究,在突尼斯的 11 个抗结核中心进行(2014 年 6 月至 11 月)。病例为年龄在 18 至 55 岁之间的新诊断和确诊的结核病患者。对照组无结核病。为每个参与者填写一份数据收集表,并进行 TST。使用接收者操作曲线(ROC)曲线和曲线下面积(AUC)估计 TST 的诊断准确性指标,以估计确定截止点的敏感性和特异性。

结果

总体而言,共有 1050 名患者入组,包括 336 例病例和 714 例对照。病例的平均年龄为 38.3±11.8 岁,对照为 33.6±11 岁。病例的 TST 硬结直径明显高于对照组(13.7mm 对 6.2mm;p=10)。AUC 为 0.789 [95%CI:0.758-0.819;p=0.01],表明该试验具有中等的鉴别性能。TST 的最具鉴别性截止值与最佳敏感性(73.7%)和特异性(76.6%)相匹配,为≥11mm,其约登指数为 0.503。阳性和阴性预测值分别为 3.11%和 99.52%。

结论

TST 可能是一种有用的工具,用于活动性肺结核的检测,具有中等的总体性能和可接受的敏感性和特异性,截止值为 11mm。然而,由于其多种缺点,不能将其视为金标准试验。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9735/11274260/16b755c541d5/f1000research-12-168401-g0000.jpg

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