PMID- 24416336 OWN - NLM STAT- MEDLINE DCOM- 20140902 LR - 20240313 IS - 1932-6203 (Electronic) IS - 1932-6203 (Linking) VI - 9 IP - 1 DP - 2014 TI - Utility of T-cell interferon-gamma release assays for diagnosing tuberculous serositis: a prospective study in Beijing, China. PG - e85030 LID - 10.1371/journal.pone.0085030 [doi] LID - e85030 AB - BACKGROUND: Diagnosis of tuberculous serositis remains a challenge. The aim of this study was to evaluate the diagnostic efficiency of T-SPOT.TB on serous effusion mononuclear cells (SEMC) for diagnosing tuberculous serositis in a high TB burden area. METHODS: The present prospective study enrolled patients with suspected tuberculous serositis in a tertiary referral hospital in Beijing, China, to investigate the diagnostic sensitivity, specificity, predictive value (PV), and likelihood ratio(LR) of these tests. Clinical assessment, T-SPOT.TB on SEMC, and T-SPOT.TB on PBMC were performed. Test results were compared with the final confirmed diagnosis. RESULTS: Of the 187 participants, 74 (39.6%) were microbiologically or clinically diagnosed as tuberculous serositis and 93(49.7%) were ruled out. The remaining 20 (10.7%) patients were clinically indeterminate and excluded from the final analysis. Compared to that on PBMC, T-SPOT.TB on SEMC showed higher sensitivity (91.9%vs73.0%, P = 0.002), specificity (87.1%vs.73.1%, P = 0.017), PPV (85.0%vs.68.4%, P = 0.013), NPV (93.1%vs.77.3%, P = 0.003), LR+ (7.12vs.2.72) and LR- (0.09vs.0.37), respectively. The frequencies of spot forming cells (SFCs) for T-SPOT.TB on SEMC were 636 per million SEMC (IQR, 143-3443) in patients with tuberculous serositis, which were 4.6-fold (IQR, 1.3-14.3) higher than those of PBMC. By ROC curve analysis, a cut-off value of 56 SFCs per million SEMC for T-SPOT.TB on SEMC showed a sensitivity of 90.5% and specificity of 89.2% for the diagnosis of tuberculous serositis. CONCLUSIONS: T-SPOT.TB on SEMC could be an accurate diagnostic method for tuberculous serositis in TB endemic settings. And 56 SFCs per million SEMC might be the optimal cut-off value to diagnose tuberculous serositis. FAU - Zhang, Lifan AU - Zhang L AD - Department of Infectious Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China ; Clinical Epidemiology Unit, Peking Union Medical College, International Clinical Epidemiology Network, Beijing, China. FAU - Zhang, Yueqiu AU - Zhang Y AD - Department of Infectious Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China. FAU - Shi, Xiaochun AU - Shi X AD - Department of Infectious Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China. FAU - Zhang, Yao AU - Zhang Y AD - Clinical Epidemiology Unit, Peking Union Medical College, International Clinical Epidemiology Network, Beijing, China. FAU - Deng, Guohua AU - Deng G AD - Department of Infectious Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China. FAU - Lalvani, Ajit AU - Lalvani A AD - Department of Respiratory Medicine, National Heart and Lung Institute, Imperial College London, London, United Kingdom. FAU - Liu, Xiaoqing AU - Liu X AD - Department of Infectious Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China ; Clinical Epidemiology Unit, Peking Union Medical College, International Clinical Epidemiology Network, Beijing, China. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20140109 PL - United States TA - PLoS One JT - PloS one JID - 101285081 RN - 0 (Reagent Kits, Diagnostic) RN - 82115-62-6 (Interferon-gamma) SB - IM MH - Adult MH - Aged MH - Ascites/*diagnosis/immunology/pathology MH - Cell Count MH - China MH - Female MH - Humans MH - Interferon-gamma/*analysis/metabolism MH - Male MH - Middle Aged MH - Pericardial Effusion/*diagnosis/immunology/pathology MH - Pleural Effusion/*diagnosis/immunology/pathology MH - Predictive Value of Tests MH - Prospective Studies MH - ROC Curve MH - Reagent Kits, Diagnostic MH - Serositis/complications/*diagnosis/immunology/pathology MH - T-Lymphocytes/immunology/pathology MH - Tertiary Care Centers MH - Tuberculosis/complications/*diagnosis/immunology/pathology PMC - PMC3887014 COIS- Competing Interests: Professor Lalvani is inventor for patents underpinning T cell-based diagnosis. The ESAT-6/CFP-10 IFN-gamma ELISpot assay was commercialised by an Oxford University spin-out company (T-SPOT.TBA(R), Oxford Immunotec Ltd, Abingdon, UK) in which the University of Oxford and Professor Lalvani have minority shares of equity and royalty entitlements. EDAT- 2014/01/15 06:00 MHDA- 2014/09/03 06:00 PMCR- 2014/01/09 CRDT- 2014/01/14 06:00 PHST- 2013/08/25 00:00 [received] PHST- 2013/11/21 00:00 [accepted] PHST- 2014/01/14 06:00 [entrez] PHST- 2014/01/15 06:00 [pubmed] PHST- 2014/09/03 06:00 [medline] PHST- 2014/01/09 00:00 [pmc-release] AID - PONE-D-13-35037 [pii] AID - 10.1371/journal.pone.0085030 [doi] PST - epublish SO - PLoS One. 2014 Jan 9;9(1):e85030. doi: 10.1371/journal.pone.0085030. eCollection 2014.