γ干扰素释放试验在基层门诊肺结核筛查中的应用及评价

doi:10.19871/j.cnki.xfcrbzz.2023.06.012

摘要/Abstract

摘要： 目的通过对γ干扰素释放试验（interferon γ release assay,IGRA）在基层门诊肺结核筛查中的临床应用,评价其应用效果和影响因素,为临床正确合理的使用提供参考意见。方法选取2021年1月至2022年12月深圳市龙华区慢性病防治中心接诊的3073例疑似初诊肺结核患者,收集患者痰液标本采用痰涂片抗酸染色（acid-fast stain,AFS）、BACTEC-MGIT 960液体培养法、交叉引物恒温扩增技术（crossing-primer amplification,CPA）对抗结核治疗前痰液标本进行结核分枝杆菌（mycobacterium tuberculosis,MTB）检测, 采集患者外周血进行IGRA,以临床诊断作为确诊依据,评价IGRA与其他方法对结核感染的检测效能。结果不同年龄患者IGRA阳性检出率存在明显统计学差异,30~40岁组阳性检出率最高,0~10岁组最低,且男性高于女性（P<0.01）。痰培养和CPA的总体诊断准确率分别为77.62%和66.88%,明显优于IGRA。IGRA的敏感度和特异度分别为72.89%和40.96%,总体诊断准确率仅为59.04%。IGRA与痰培养或CPA联用可显著提高检测敏感度（86.89%和84.22%）,但总体诊断效率无明显提升（67.39%比77.62%,65.86%比66.88%）。IGRA对确诊肺结核患者的临床诊断符合率为72.89%,假阴性率为27.11%,对非肺结核患者的临床诊断符合率为40.96%（136/332）,假阳性率为59.34%,对肺结核诊断的阳性预测值和阴性预测值都明显低于液体培养法。IGRA对菌阴肺结核和菌阳肺结核的检出率无明显差异（χ²=0.147,P=0.7014）。结论尽管IGRA有较好的敏感度,但实际应用中存在一定的假阳性率和假阴性率,相较于病原学检测,其对目标患病或密接人群的肺结核筛查有一定优势,但排除非结核病的效能不足,期望与其他方法联用提高其检测效能。

关键词: 结核分枝杆菌, 痰培养, 交叉引物恒温扩增技术, γ干扰素释放试验, 对比分析

Abstract: Objective Through the clinical application of γ interferon release Assay(IGRA) in primary outpatient tuberculosis screening, the application effect and influencing factors can be evaluated to provide reference opinions for correct and reasonable clinical use. Method 3073 suspected newly diagnosed pulmonary tuberculosis patients who were treated at the Longhua District Chronic Disease Prevention and Control Center in Shenzhen from January 2021 to December 2022 were selected, and sputum samples were collected using acid-fast stain（AFS), BACTEC-MGIT 960 liquid culture method, and other methods crossing-primer amplification (CPA) technology was used to detect Mycobacterium tuberculosis (MTB) in sputum samples before treatment. Peripheral blood samples were collected for IGRA, and positive MGIT 960 liquid culture was used as the reference standard for tuberculosis infection. Clinical diagnosis was used as the diagnostic criterion to evaluate the detection efficiency of IGRA and other methods for tuberculosis infection. Result There is a significant statistical difference in the positive detection rate of IGRA among patients of different ages, with the highest positive detection rate in the 30-40 year old group and the lowest in the 0-10 year old group, with males being higher than females (P<0.01). Among several methods, the overall diagnostic accuracy of culture and CPA were 77.62% and 66.88%, respectively, which were significantly better than IGRA. The sensitivity and specificity of IGRA were 72.89% and 40.96%, respectively, with an overall diagnostic accuracy of only 59.04%. IGRA combined with culture or CPA can significantly improve detection sensitivity (86.89% and 84.22%), but there is no significant improvement in overall diagnostic efficiency (67.39% vs 77.62%, 65.86% vs 66.88%). The clinical diagnostic accuracy of IGRA for confirmed tuberculosis patients was 72.89%, with a false negative rate of 27.11%. The clinical diagnostic accuracy with non tuberculosis patients was 40.96% (136/332), with a false positive rate of 59.34%. The positive and negative predictive values for tuberculosis diagnosis were significantly lower than those of culture. There was no significant difference in the detection rate of IGRA for bacterial negative tuberculosis and bacterial positive tuberculosis (χ²=0.147, P=0.7014). Conclusion Although IGRA has good sensitivity, there are certain false positive and false negative rates in practical applications. Compared to pathogen detection, it has advantages in early screening of target disease or close contacts. However, its effectiveness in eliminating tuberculosis is insufficient, and it can be combined with other methods to improve its detection efficiency.

Key words: Mycobacterium tuberculosis, Phlegm culture, Crossing-primer amplification, Interferon gamma release assay, Comparative analysis

中图分类号:

R521
R446.5

刘昌伟, 马玲娣, 魏振华, 蒋淑萍, 李斌, 王艳, 黄敏聪. γ干扰素释放试验在基层门诊肺结核筛查中的应用及评价[J]. 新发传染病电子杂志, 2023, 8(6): 63-68.

Liu Changwei, Ma Lingdi, Wei Zhenhua, Jiang Shuping, Li Bin, Wang Yan, Huang Mincong. Application and evaluation of γ-interferon releasing test in tuberculosis screening in general practice outpatients[J]. Electronic Journal of Emerging Infectious Diseases, 2023, 8(6): 63-68.

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