Tuberculous pleurisy (TBP) is the most common form of extrapulmonary tuberculosis (TB). However, rapid diagnostic methods with high accuracy for tuberculous pleurisy are urgently needed. In the present study, we evaluated the diagnostic accuracy of Xpert MTB/RIF, LAMP and SAT-TB assay with pleural fluids from culture-positive TBP patients. We prospectively enrolled 300 patients with exudative pleural effusions used as the samples for Xpert MTB/RIF, LAMP and SAT-TB assay. Of these, 265 including 223 patients diagnosed with TBP and 42 non-TBP patients used as controls were analyzed. The sensitivities of Xpert MTB/RIF (27.4%), LAMP (26.5%) and SAT-TB assay (32.3%) were significantly higher than that of pleural effusion smear (14.3%, X2 = 20.65, P < 0.001), whereas they were much lower than expected for the analysis of pleural effusion samples. Both SAT-TB assay and Xpert MTB/RIF demonstrated high specificities (100%) and PPVs (100%), but the NPVs of all of the tests were < 22%. The area under ROC curve of pleural effusion smear, LAMP, Xpert MTB/RIF and SAT-TB assays was 0.524 (95% CI 0.431–0.617), 0.632 (95% CI 0.553–0.71), 0.637 (95% CI 0.56–0.714) and 0.673 (95% CI 0.6–0.745). SAT-TB assays had the highest AUC. Nucleic acid amplification tests are not the first choice in the diagnosis of tuberculous pleurisy. In this type of test, SAT-TB is recommended because of its low cost, relatively more accurate compared with the other two tests. This prospective study was approved by The Ethics Committee of the Shanghai Pulmonary Hospital (approval number: K19–148). ClinicalTrials.gov identifier: ChiCTR1900026234 (Retrospectively registered). The registration date is September 28, 2019.

中文翻译：

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核酸测试在结核性胸膜炎中的诊断性能。

结核性胸膜炎（TBP）是肺外结核（TB）的最常见形式。然而，迫切需要针对结核性胸膜炎的高精度的快速诊断方法。在本研究中，我们评估了Xpert MTB / RIF，LAMP和SAT-TB检测对培养阳性TBP患者的胸膜液的诊断准确性。我们前瞻性地招募了300例渗出性胸腔积液患者，作为Xpert MTB / RIF，LAMP和SAT-TB分析的样本。其中，分析了265例患者，包括223名被诊断为TBP的患者和42例非TBP患者作为对照。Xpert MTB / RIF（27.4％），LAMP（26.5％）和SAT-TB分析（32.3％）的敏感性显着高于胸腔积液涂片（14.3％，X2 = 20.65，P <0.001）。远低于对胸腔积液分析的预期。SAT-TB分析和Xpert MTB / RIF均显示出高特异性（100％）和PPV（100％），但所有测试的NPV均<22％。胸腔积液涂片，LAMP，Xpert MTB / RIF和SAT-TB测定的ROC曲线下面积分别为0.524（95％CI 0.431-0.617），0.632（95％CI 0.553-0.71），0.637（95％CI 0.56-0.714） ）和0.673（95％CI 0.6-0.745）。SAT-TB检测的AUC最高。核酸扩增测试不是诊断结核性胸膜炎的首选。在这种类型的测试中，推荐使用SAT-TB，因为它的成本较低，与其他两种测试相比，其准确性更高。这项前瞻性研究得到了上海肺科医院伦理委员会的批准（批准文号：K19–148）。ClinicalTrials.gov标识符：ChiCTR1900026234（已追溯注册）。注册日期为2019年9月28日。