台湾地区疑似肺结核患者核酸扩增检测的表现

Performance of Nucleic Acid Amplification Tests in Patients with Presumptive Pulmonary Tuberculosis in Taiwan.

作者信息

Huang Wei-Chang, Lin Chih-Bin, Chien Shun-Tien, Wang Jann-Yuan, Lin Chou-Jui, Feng Jia-Yih, Lee Chih-Hsin, Shu Chin-Chung, Yu Ming-Chih, Lee Jen-Jyh, Chiang Chen-Yuan

机构信息

Division of Chest Medicine, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, 407, Taiwan.

Department of Post-Baccalaureate Medicine, College of Medicine, National Chung Hsing University, Taichung, 402, Taiwan.

出版信息

Infect Dis Ther. 2022 Apr;11(2):871-885. doi: 10.1007/s40121-022-00610-2. Epub 2022 Mar 7.

DOI:10.1007/s40121-022-00610-2

PMID:35254635

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8900096/

Abstract

INTRODUCTION

Several nucleic acid amplification tests (NAATs) for detection of Mycobacterium tuberculosis (TB) complex (MTBC) are available in Taiwan; however, their performances may differ and have not been extensively evaluated. Therefore, we aimed to explore the accuracy of NAATs overall followed by comparison between platforms commonly used in Taiwan.

METHODS

This study enrolled presumptive pulmonary TB patients with NAATs throughout Taiwan. The diagnostic performance of smear microscopy and NAATs was assessed using sputum culture as a reference standard. To investigate the performance of NAATs in excluding non-tuberculous mycobacteria (NTM), we quantified the false-positive proportion of NAATs in patients infected with NTM.

RESULTS

Of the 4126 enrollees, 860 (20.8%) had positive NAATs. The sensitivity and specificity of NAATs were 83.2% and 96.7%, respectively, compared to 81.5% and 55.3% for smear. There was no significant difference in sensitivity between the NAATs and smear; however, the specificity of smear was significantly lower than that of the NAATs [difference 41.4%, 95% confidence interval (CI) 39.6-43.2%]. There was no significant difference in sensitivity among Roche Cobas Amplicor Mycobacterium tuberculosis assay (Amplicor), Xpert MTB/RIF assay (Xpert) and in-house polymerase chain reaction (in-house PCR) (82.2% versus 83.8% versus 82.4%); however, in-house PCR was significantly less specific than Amplicor (difference 5.3%, 95% CI 2.4-8.2%) and Xpert (difference 5.8%, 95% CI 3.1-8.5%). The sensitivity of NAATs among smear-negative cases was 33.1% (95% CI 26.0-40.3%). In-house PCR had a significantly higher false-positive rate among specimens that were culture positive for NTM than Amplicor (7.7% versus 0.3%; difference 7.4%, 95% CI 3.4-11.5%) and Xpert (7.7% versus 0.7%; difference 7.0%, 95% CI 2.9-11.0%).

CONCLUSION

The NAATs overall had a relatively high sensitivity and specificity in detecting MTBC while Amplicor and Xpert performed better than in-house PCR in excluding NTM. Our findings will be useful for the development of national policy.

摘要

引言

台湾有几种用于检测结核分枝杆菌复合群（MTBC）的核酸扩增试验（NAATs）；然而，它们的性能可能有所不同，且尚未得到广泛评估。因此，我们旨在总体探索NAATs的准确性，随后比较台湾常用平台之间的差异。

方法

本研究纳入了全台湾疑似肺结核且接受NAATs检测的患者。以痰培养作为参考标准，评估涂片显微镜检查和NAATs的诊断性能。为了研究NAATs在排除非结核分枝杆菌（NTM）方面的性能，我们对NTM感染患者中NAATs的假阳性比例进行了量化。

结果

在4126名受试者中，860人（20.8%）的NAATs呈阳性。与涂片检查的敏感性81.5%和特异性55.3%相比，NAATs的敏感性和特异性分别为83.2%和96.7%。NAATs与涂片检查的敏感性无显著差异；然而，涂片检查的特异性显著低于NAATs[差异41.4%，95%置信区间（CI）39.6 - 43.2%]。罗氏Cobas Amplicor结核分枝杆菌检测（Amplicor）、Xpert MTB/RIF检测（Xpert）和内部聚合酶链反应（内部PCR）之间的敏感性无显著差异（82.2%对83.8%对82.4%）；然而，内部PCR的特异性显著低于Amplicor（差异5.3%，95% CI 2.4 - 8.2%）和Xpert（差异5.8%，95% CI 3.1 - 8.5%）。涂片阴性病例中NAATs的敏感性为33.1%（95% CI 26.0 - 40.3%）。在NTM培养阳性的标本中，内部PCR的假阳性率显著高于Amplicor（7.7%对0.3%；差异7.4%，95% CI 3.4 - 11.5%）和Xpert（7.7%对0.7%；差异7.0%，95% CI 2.9 - 11.0%）。