SAT-TB assay had the highest diagnostic accuracy for tuberculous pleurisy among nucleic acid tests with an AUC of 0.673 (95% CI 0.6-0.745), though all tests had low negative predictive values (<22%).
Observational (n=265)
No
Do nucleic acid tests (Xpert MTB/RIF, LAMP, SAT-TB) accurately diagnose tuberculous pleurisy in patients with exudative pleural effusions?
Nucleic acid amplification tests have low negative predictive value for diagnosing tuberculous pleurisy from pleural effusion samples, though SAT-TB is the most accurate among those tested.
Effect estimate: AUC 0.673 (95% CI 0.6-0.745)
BACKGROUND: 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. METHODS: 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. RESULTS: = 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. CONCLUSION: 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). TRIAL REGISTRATION: ClinicalTrials.gov identifier: ChiCTR1900026234 (Retrospectively registered). The registration date is September 28, 2019.
Han et al. (Tue,) conducted a observational in Tuberculous pleurisy (n=265). Nucleic acid amplification tests (Xpert MTB/RIF, LAMP, SAT-TB) vs. Non-TBP patients was evaluated on Area under ROC curve for SAT-TB assay (AUC 0.673, 95% CI 0.6-0.745). SAT-TB assay had the highest diagnostic accuracy for tuberculous pleurisy among nucleic acid tests with an AUC of 0.673 (95% CI 0.6-0.745), though all tests had low negative predictive values (<22%).