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The Performance of Pleural Fluid T-SPOT.TB Assay for Diagnosing Tuberculous Pleurisy in China: A Two-Center Prospective Cohort Study.

ABSTRACT: The performance of T-SPOT.TB (T-SPOT) assay in diagnosing pleural tuberculosis (plTB) is inconsistent. In this study, we compared the performance of peripheral blood (PB) and pleural fluid (PF) T-SPOT assay in diagnosing plTB. Between July 2017 and March 2018, 218 and 210 suspected plTB patients were prospectively enrolled from Wuhan (training) and Guangzhou (validation) cohort, respectively. PB T-SPOT, PF T-SPOT, and other conventional tests were simultaneously performed. Our data showed the performance of PB T-SPOT in diagnosing plTB was limited, especially with low sensitivity. However, the results of early secreted antigenic target 6 (ESAT-6) and culture filtrate protein 10 (CFP-10) in PF T-SPOT were significantly increased compared with those in PB T-SPOT in plTB patients. If using 76 as the cutoff value of MAX (the larger of ESAT-6 and CFP-10) in Wuhan cohort, the sensitivity and specificity of PF T-SPOT to diagnose plTB were 89.76 and 96.70%, respectively. The diagnostic accuracy of PF T-SPOT was better than other routine tests such as pathogen detection methods and biochemical markers. The diagnostic accuracy of PF T-SPOT in Guangzhou cohort was similar to that in Wuhan cohort, with a sensitivity and specificity of 91.07 and 94.90%, respectively. Furthermore, CD4+ T cells were more activated in PF compared with PB, and the frequency of mycobacterium tuberculosis-specific CD4+ T cells in PF was significantly higher than that in PB in plTB patients. In conclusion, the performance of PF T-SPOT is obviously better than PB T-SPOT or other laboratory tests, which suggests that PF T-SPOT assay has been of great value in the diagnosis of pleural tuberculosis.

SUBMITTER: Luo Y

PROVIDER: S-EPMC6363671 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Project description:BACKGROUND Traditional diagnostic methods for tuberculosis (TB) cannot be reliably applied to tuberculous pleurisy. Therefore, this prospective, randomized, controlled trial was performed to compare the diagnostic sensitivity and safety of ultrasound-guided cutting-needle pleural biopsy versus thoracoscopic pleural biopsy in patients suspected of tuberculous pleurisy following inconclusive thoracentesis. MATERIAL AND METHODS A total of 196 adult patients with acid-fast bacillus (AFB)-negative exudative pleural effusions clinically suspected of tuberculous pleurisy were recruited. Enrollees were randomized into 2 cohorts: ultrasound-guided cutting-needle pleural biopsy (n=96) or thoracoscopic pleural biopsy (n=96). The overall diagnostic yields, diagnostic sensitivities for tuberculous pleurisy, and post-procedural complications for both cohorts were statistically compared. RESULTS Ultrasound-guided pleural biopsy displayed an overall diagnostic yield of 83%, while thorascopic pleural biopsy displayed a similar overall diagnostic yield of 86% (χ²=1.88, df=1, p=0.17). There were 127 patients conclusively diagnosed with tuberculous pleurisy, resulting in a tuberculous pleurisy prevalence of 65% in this patient population (66% in the ultrasound cohort vs. 63% in the thoracoscopy cohort; p>0.05). Ultrasound-guided pleural biopsy displayed a sensitivity of 82% in detecting tuberculous pleurisy, while thorascopic pleural biopsy displayed a similar sensitivity of 90% (χ²=1.05, df=1, p=0.30). The sensitivities of these 2 modalities did not significantly differ based on the degree of pleural thickening (p>0.05). Post-procedural complications were minor. CONCLUSIONS Ultrasound-guided and thoracoscopic pleural biopsy both display strong (>80%) but statistically similar overall diagnostic yields for diagnosing pleural effusions following inconclusive thoracentesis. Both modalities also display strong (>80%) but statistically similar sensitivities in detecting tuberculous pleurisy.

Project description:Background: The role of T-SPOT.TB (T-SPOT) assay for tuberculous meningitis (TBM) diagnosis has not been fully assessed. Here, we conducted an updated meta-analysis to evaluate the diagnostic accuracy of peripheral blood (PB) T-SPOT and cerebrospinal fluid (CSF) T-SPOT for diagnosing TBM. Methods: Relevant studies in the PubMed database, EmBase database, Cochrane database, Scopus database, Google Scholar, China National Knowledge Internet, and Wan-Fang database were retrieved from August 1, 2005, to June 22, 2020. Statistical analysis was performed using Stata, Revman, and Meta-Disc software. The pooled sensitivity, specificity, positive likelihood ratio (PLR), negative likelihood ratio (NLR), diagnostic odds ratio (DOR), summary receiver operating characteristic curves, and the area under the curve were determined and analyzed. Results: A total of 27 studies were eligible for inclusion within the meta-analysis. The pooled sensitivity and specificity of PB T-SPOT for TBM diagnosis were 0.78 (95% CI, 0.76–0.81) and 0.68 (95% CI, 0.66–0.71), respectively, whereas the pooled PLR, NLR, and DOR were 2.80 (95% CI, 2.29–3.42), 0.32 (95% CI, 0.27–0.38), and 10.08 (95% CI, 7.21–14.08), respectively. On the other hand, the pooled sensitivity and specificity of CSF T-SPOT on diagnosing TBM were 0.76 (95% CI, 0.72–0.80) and 0.88 (95% CI, 0.85–0.90), respectively, whereas the pooled PLR, NLR, and DOR were 5.92 (95% CI, 4.25–8.25), 0.28 (95% CI, 0.21–0.39), and 29.05 (95% CI, 16.40–51.45), respectively. The area under the summary receiver operating characteristic curve values of PB T-SPOT and CSF T-SPOT for TBM diagnosis were 0.83 (95% CI, 0.80–0.86) and 0.92 (95% CI, 0.89–0.94), respectively. Conclusions: CSF T-SPOT showed a higher specificity compared with PB T-SPOT for diagnosing TBM. Both two T-SPOT assays have considerable potential in improving the diagnosis of TBM. Furthermore, the standardization of the operating procedure is further needed when performing CSF T-SPOT.

Dataset Information

The Performance of Pleural Fluid T-SPOT.TB Assay for Diagnosing Tuberculous Pleurisy in China: A Two-Center Prospective Cohort Study.

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