Comparison of same day diagnostic tools including Gene Xpert and unstimulated IFN-γ for the evaluation of pleural tuberculosis: a prospective cohort study

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dc.contributor.authorMeldau, Richard
dc.contributor.authorPeter, Jonny
dc.contributor.authorTheron, Grant
dc.contributor.authorCalligaro, Greg
dc.contributor.authorAllwood, Brian
dc.contributor.authorSymons, Greg
dc.contributor.authorKhalfey, Hoosain
dc.contributor.authorNtombenhle, Gina
dc.contributor.authorGovender, Ureshnie
dc.contributor.authorBinder, Anke
dc.contributor.authorvan Zyl-Smit, Richard
dc.contributor.authorDheda, Keertan
dc.date.accessioned2015-01-27T11:48:33Z
dc.date.available2015-01-27T11:48:33Z
dc.date.issued2014-04-08
dc.date.updated2015-01-15T17:55:09Z
dc.description.abstractBackground: The accuracy of currently available same-day diagnostic tools (smear microscopy and conventional nucleic acid amplification tests) for pleural tuberculosis (TB) is sub-optimal. Newer technologies may offer improved detection. Methods: Smear-microscopy, adenosine deaminase (ADA), interferon gamma (IFN-γ), and Xpert MTB/RIF [using an unprocessed (1 ml) and centrifuged (~20 ml) sample] test accuracy was evaluated in pleural fluid from 103 consecutive patients with suspected pleural TB. Culture for M.tuberculosis and/or histopathology (pleural biopsy) served as the reference standard. Patients were followed prospectively to determine their diagnostic categorisation. Results: Of 93 evaluable participants, 40 had definite-TB (reference positive), 5 probable-TB (not definite but treated for TB) and 48 non-TB (culture and histology negative, and not treated for TB). Xpert MTB/RIF sensitivity and specificity (95% CI) was 22.5% (12.4 - 37.6) and 98% (89.2 - 99.7), respectively, and centrifugation did not improve sensitivity (23.7%). The Xpert MTB/RIF internal positive control showed no evidence of inhibition. Biomarker specific sensitivity, specificity, PPV, and NPVs were: ADA (48.85 IU/L; rule-in cut-point) 55.3% (39.8 - 69.9), 95.2% (83.9 - 98.7), 91.4 (73.4 - 95.4), 69.7% (56.7 - 80.1); ADA (30 IU/L; clinically used cut-point) 79% (63.7 - 89), 92.7% (80.6 - 97.5), 91.0 (73.4 - 95.4), 82.7% (69.3 - 90.1); and IFN-γ (107.7 pg/ml; rule-in cut-point) 92.5% (80.2 - 97.5), 95.9% (86.1 - 98.9), 94.9% (83.2 - 98.6), 93.9% (83.5 - 97.9), respectively (IFN-γ sensitivity and NPV better than Xpert [p < 0.05] and rule-in ADA [p < 0.05]). Conclusion: The usefulness of Xpert MTB/RIF to diagnose pleural TB is limited by its poor sensitivity. IFN-γ is an excellent rule-in test and, compared to ADA, has significantly better sensitivity and rule-out value in a TB-endemic setting.en_ZA
dc.identifier.apacitationMeldau, R., Peter, J., Theron, G., Calligaro, G., Allwood, B., Symons, G., ... Dheda, K. (2014). Comparison of same day diagnostic tools including Gene Xpert and unstimulated IFN-γ for the evaluation of pleural tuberculosis: a prospective cohort study. <i>BMC Pulmonary Medicine</i>, http://hdl.handle.net/11427/12334en_ZA
dc.identifier.chicagocitationMeldau, Richard, Jonny Peter, Grant Theron, Greg Calligaro, Brian Allwood, Greg Symons, Hoosain Khalfey, et al "Comparison of same day diagnostic tools including Gene Xpert and unstimulated IFN-γ for the evaluation of pleural tuberculosis: a prospective cohort study." <i>BMC Pulmonary Medicine</i> (2014) http://hdl.handle.net/11427/12334en_ZA
dc.identifier.citationMeldau et al.: Comparison of same day diagnostic tools including Gene Xpert and unstimulated IFN-γ for the evaluation of pleural tuberculosis: a prospective cohort study.BMC Pulmonary Medicine. 2014 14(1):58en_ZA
dc.identifier.issn1471-2466en_ZA
dc.identifier.ris TY - Journal Article AU - Meldau, Richard AU - Peter, Jonny AU - Theron, Grant AU - Calligaro, Greg AU - Allwood, Brian AU - Symons, Greg AU - Khalfey, Hoosain AU - Ntombenhle, Gina AU - Govender, Ureshnie AU - Binder, Anke AU - van Zyl-Smit, Richard AU - Dheda, Keertan AB - Background: The accuracy of currently available same-day diagnostic tools (smear microscopy and conventional nucleic acid amplification tests) for pleural tuberculosis (TB) is sub-optimal. Newer technologies may offer improved detection. Methods: Smear-microscopy, adenosine deaminase (ADA), interferon gamma (IFN-γ), and Xpert MTB/RIF [using an unprocessed (1 ml) and centrifuged (~20 ml) sample] test accuracy was evaluated in pleural fluid from 103 consecutive patients with suspected pleural TB. Culture for M.tuberculosis and/or histopathology (pleural biopsy) served as the reference standard. Patients were followed prospectively to determine their diagnostic categorisation. Results: Of 93 evaluable participants, 40 had definite-TB (reference positive), 5 probable-TB (not definite but treated for TB) and 48 non-TB (culture and histology negative, and not treated for TB). Xpert MTB/RIF sensitivity and specificity (95% CI) was 22.5% (12.4 - 37.6) and 98% (89.2 - 99.7), respectively, and centrifugation did not improve sensitivity (23.7%). The Xpert MTB/RIF internal positive control showed no evidence of inhibition. Biomarker specific sensitivity, specificity, PPV, and NPVs were: ADA (48.85 IU/L; rule-in cut-point) 55.3% (39.8 - 69.9), 95.2% (83.9 - 98.7), 91.4 (73.4 - 95.4), 69.7% (56.7 - 80.1); ADA (30 IU/L; clinically used cut-point) 79% (63.7 - 89), 92.7% (80.6 - 97.5), 91.0 (73.4 - 95.4), 82.7% (69.3 - 90.1); and IFN-γ (107.7 pg/ml; rule-in cut-point) 92.5% (80.2 - 97.5), 95.9% (86.1 - 98.9), 94.9% (83.2 - 98.6), 93.9% (83.5 - 97.9), respectively (IFN-γ sensitivity and NPV better than Xpert [p < 0.05] and rule-in ADA [p < 0.05]). Conclusion: The usefulness of Xpert MTB/RIF to diagnose pleural TB is limited by its poor sensitivity. IFN-γ is an excellent rule-in test and, compared to ADA, has significantly better sensitivity and rule-out value in a TB-endemic setting. DA - 2014-04-08 DB - OpenUCT DO - 10.1186/1471-2466-14-58 DP - University of Cape Town J1 - BMC Pulmonary Medicine LK - https://open.uct.ac.za PB - University of Cape Town PY - 2014 SM - 1471-2466 T1 - Comparison of same day diagnostic tools including Gene Xpert and unstimulated IFN-γ for the evaluation of pleural tuberculosis: a prospective cohort study TI - Comparison of same day diagnostic tools including Gene Xpert and unstimulated IFN-γ for the evaluation of pleural tuberculosis: a prospective cohort study UR - http://hdl.handle.net/11427/12334 ER - en_ZA
dc.identifier.urihttp://hdl.handle.net/11427/12334
dc.identifier.urihttp://dx.doi.org/10.1186/1471-2466-14-58
dc.identifier.vancouvercitationMeldau R, Peter J, Theron G, Calligaro G, Allwood B, Symons G, et al. Comparison of same day diagnostic tools including Gene Xpert and unstimulated IFN-γ for the evaluation of pleural tuberculosis: a prospective cohort study. BMC Pulmonary Medicine. 2014; http://hdl.handle.net/11427/12334.en_ZA
dc.languageengen_ZA
dc.language.rfc3066en
dc.publisherBioMed Centralen_ZA
dc.publisher.departmentDivision of Pulmonologyen_ZA
dc.publisher.facultyFaculty of Health Sciencesen_ZA
dc.publisher.institutionUniversity of Cape Town
dc.rightsAttribution 2.0 Generic (CC BY 2.0)*
dc.rights.holderMeldau et al.; licensee BioMed Central Ltd.
dc.rights.urihttp://creativecommons.org/licenses/by/2.0/en_ZA
dc.sourceBMC Pulmonary Medicineen_ZA
dc.source.urihttp://www.biomedcentral.com/1471-2466
dc.subject.otherTuberculosisen_ZA
dc.subject.otherXpert MTB/RIFen_ZA
dc.subject.otherInterferon gammaen_ZA
dc.subject.otherAdenosine deaminaseen_ZA
dc.subject.otherPleural fluiden_ZA
dc.titleComparison of same day diagnostic tools including Gene Xpert and unstimulated IFN-γ for the evaluation of pleural tuberculosis: a prospective cohort studyen_ZA
dc.typeJournal Articleen_ZA
uct.type.filetypeText
uct.type.filetypeImage
uct.type.publicationResearchen_ZA
uct.type.resourceArticleen_ZA
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