Jo Yong Suk, Park Ju-Hee, Lee Jung Kyu, Heo Eun Young, Chung Hee Soon, Kim Deog Kyeom
Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.
Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul National University College of Medicine, Seoul, Republic of Korea.
PLoS One. 2016 Oct 19;11(10):e0164923. doi: 10.1371/journal.pone.0164923. eCollection 2016.
The prevalence and clinical implications of discordance between Xpert MTB/RIF assays and the AdvanSure TB/NTM real-time polymerase chain reaction (PCR) for bronchial washing specimens have not been studied in pulmonary TB (PTB) patients. The discordant proportion and its clinical impact were evaluated in 320 patients from the bronchoscopy registry whose bronchial washing specimens were tested simultaneously with Xpert MTB/RIF and the TB/NTM PCR assay for three years, and the accuracy of the assays, including the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), were studied. The clinical risk factors for discordance and false positivity of assays were also studied. Among 130 patients who were clinically diagnosed with PTB, 64 patients showed positive acid-fast bacilli culture results, 56 patients showed positive results in molecular methods and clinician diagnosed PTB without results of microbiology in 10 patients. The sensitivity, specificity, PPV, and NPV were 80.0%, 98.95%, 98.1%, and 87.9%, respectively, for Xpert MTB/RIF and 81.5%, 92.6%, 88.3%, and 88.0%, respectively, for TB/NTM PCR. The discordant proportion was 16.9% and was higher in culture-negative PTB compared to culture-confirmed PTB (24.3% vs. 9.4%, p = 0.024). However, there were no significant differences in the clinical characteristics, regardless of the discordance. The diagnostic yield increased with an additional assay (7.7% for Xpert MTB/RIF and 9.2% for TB/NTM PCR). False positivity was less common in patients tested with Xpert MTB/RIF (1.05% vs. 7.37%, p = 0.0035). No host-related risk factor for false positivity was identified. The Xpert MTB/RIF and TB/NTM PCR assay in bronchial washing specimens can improve the diagnostic yields for PTB, although there were considerable discordant results without any patient-related risk factors.
对于肺结核(PTB)患者,尚未研究Xpert MTB/RIF检测与AdvanSure TB/NTM实时聚合酶链反应(PCR)在支气管灌洗标本检测结果不一致的患病率及其临床意义。对支气管镜登记处的320例患者进行了评估,这些患者的支气管灌洗标本同时进行了Xpert MTB/RIF和TB/NTM PCR检测,为期三年,研究了检测的准确性,包括敏感性、特异性、阳性预测值(PPV)和阴性预测值(NPV)。还研究了检测结果不一致和假阳性的临床危险因素。在130例临床诊断为PTB的患者中,64例患者抗酸杆菌培养结果为阳性,56例患者分子检测结果为阳性,10例患者临床诊断为PTB但微生物学检测无结果。Xpert MTB/RIF的敏感性、特异性、PPV和NPV分别为80.0%、98.95%、98.1%和87.9%,TB/NTM PCR的敏感性、特异性、PPV和NPV分别为81.5%、92.6%、88.3%和88.0%。不一致比例为16.9%,培养阴性的PTB患者高于培养确诊的PTB患者(24.3%对9.4%,p = 0.024)。然而,无论检测结果是否一致,临床特征均无显著差异。额外检测可提高诊断率(Xpert MTB/RIF为7.7%,TB/NTM PCR为9.2%)。Xpert MTB/RIF检测的患者假阳性较少见(1.05%对7.37%,p = 0.0035)。未发现与宿主相关的假阳性危险因素。支气管灌洗标本中的Xpert MTB/RIF和TB/NTM PCR检测可提高PTB的诊断率,尽管存在相当多的不一致结果,且无任何与患者相关的危险因素。