Clinical utility of a commercial LAM-ELISA assay for TB diagnosis in HIV-infected patients using urine and sputum samples

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dc.contributor.authorDheda, Keertanen_ZA
dc.contributor.authorDavids, Virginiaen_ZA
dc.contributor.authorLenders, Lauraen_ZA
dc.contributor.authorRoberts, Terien_ZA
dc.contributor.authorMeldau, Richarden_ZA
dc.contributor.authorLing, Daphneen_ZA
dc.contributor.authorBrunet, Laurenceen_ZA
dc.contributor.authorSmit, Richard van Zylen_ZA
dc.contributor.authorPeter, Jonathanen_ZA
dc.contributor.authorGreen, Clareen_ZA
dc.contributor.authorBadri, Motasimen_ZA
dc.contributor.authorSechi, Leonardoen_ZA
dc.contributor.authorSharma, Surendraen_ZA
dc.contributor.authorHoelscher, Michaelen_ZA
dc.contributor.authorDawson, Rodneyen_ZA
dc.date.accessioned2016-01-11T06:51:41Z
dc.date.available2016-01-11T06:51:41Z
dc.date.issued2010en_ZA
dc.description.abstractBACKGROUND: The accurate diagnosis of TB in HIV-infected patients, particularly with advanced immunosuppression, is difficult. Recent studies indicate that a lipoarabinomannan (LAM) assay (Clearview-TB®-ELISA) may have some utility for the diagnosis of TB in HIV-infected patients; however, the precise subgroup that may benefit from this technology requires clarification. The utility of LAM in sputum samples has, hitherto, not been evaluated. METHODS: LAM was measured in sputum and urine samples obtained from 500 consecutively recruited ambulant patients, with suspected TB, from 2 primary care clinics in South Africa. Culture positivity for M. tuberculosis was used as the reference standard for TB diagnosis. RESULTS: Of 440 evaluable patients 120/387 (31%) were HIV-infected. Urine-LAM positivity was associated with HIV positivity (p = 0.007) and test sensitivity, although low, was significantly higher in HIV-infected compared to uninfected patients (21% versus 6%; p<0.001), and also in HIV-infected participants with a CD4 <200 versus >200 cells/mm 3 (37% versus 0%; p = 0.003). Urine-LAM remained highly specific in all 3 subgroups (95%-100%). 25% of smear-negative but culture-positive HIV-infected patients with a CD4 <200 cells/mm 3 were positive for urine-LAM. Sputum-LAM had good sensitivity (86%) but poor specificity (15%) likely due to test cross-reactivity with several mouth-residing organisms including actinomycetes and nocardia species. CONCLUSIONS: These preliminary data indicate that in a high burden primary care setting the diagnostic usefulness of urine-LAM is limited, as a rule-in test, to a specific patient subgroup i.e. smear-negative HIV-infected TB patients with a CD4 count <200 cells/mm 3 , who would otherwise have required further investigation. However, even in this group sensitivity was modest. Future and adequately powered studies in a primary care setting should now specifically target patients with suspected TB who have advanced HIV infection.en_ZA
dc.identifier.apacitationDheda, K., Davids, V., Lenders, L., Roberts, T., Meldau, R., Ling, D., ... Dawson, R. (2010). Clinical utility of a commercial LAM-ELISA assay for TB diagnosis in HIV-infected patients using urine and sputum samples. <i>PLoS One</i>, http://hdl.handle.net/11427/16255en_ZA
dc.identifier.chicagocitationDheda, Keertan, Virginia Davids, Laura Lenders, Teri Roberts, Richard Meldau, Daphne Ling, Laurence Brunet, et al "Clinical utility of a commercial LAM-ELISA assay for TB diagnosis in HIV-infected patients using urine and sputum samples." <i>PLoS One</i> (2010) http://hdl.handle.net/11427/16255en_ZA
dc.identifier.citationDheda, K., Davids, V., Lenders, L., Roberts, T., Meldau, R., Ling, D., ... & Badri, M. (2010). Clinical utility of a commercial LAM-ELISA assay for TB diagnosis in HIV-infected patients using urine and sputum samples. PloS one, 5(3), e9848-e9848. doi:10.1371/journal.pone.0009848en_ZA
dc.identifier.ris TY - Journal Article AU - Dheda, Keertan AU - Davids, Virginia AU - Lenders, Laura AU - Roberts, Teri AU - Meldau, Richard AU - Ling, Daphne AU - Brunet, Laurence AU - Smit, Richard van Zyl AU - Peter, Jonathan AU - Green, Clare AU - Badri, Motasim AU - Sechi, Leonardo AU - Sharma, Surendra AU - Hoelscher, Michael AU - Dawson, Rodney AB - BACKGROUND: The accurate diagnosis of TB in HIV-infected patients, particularly with advanced immunosuppression, is difficult. Recent studies indicate that a lipoarabinomannan (LAM) assay (Clearview-TB®-ELISA) may have some utility for the diagnosis of TB in HIV-infected patients; however, the precise subgroup that may benefit from this technology requires clarification. The utility of LAM in sputum samples has, hitherto, not been evaluated. METHODS: LAM was measured in sputum and urine samples obtained from 500 consecutively recruited ambulant patients, with suspected TB, from 2 primary care clinics in South Africa. Culture positivity for M. tuberculosis was used as the reference standard for TB diagnosis. RESULTS: Of 440 evaluable patients 120/387 (31%) were HIV-infected. Urine-LAM positivity was associated with HIV positivity (p = 0.007) and test sensitivity, although low, was significantly higher in HIV-infected compared to uninfected patients (21% versus 6%; p<0.001), and also in HIV-infected participants with a CD4 <200 versus >200 cells/mm 3 (37% versus 0%; p = 0.003). Urine-LAM remained highly specific in all 3 subgroups (95%-100%). 25% of smear-negative but culture-positive HIV-infected patients with a CD4 <200 cells/mm 3 were positive for urine-LAM. Sputum-LAM had good sensitivity (86%) but poor specificity (15%) likely due to test cross-reactivity with several mouth-residing organisms including actinomycetes and nocardia species. CONCLUSIONS: These preliminary data indicate that in a high burden primary care setting the diagnostic usefulness of urine-LAM is limited, as a rule-in test, to a specific patient subgroup i.e. smear-negative HIV-infected TB patients with a CD4 count <200 cells/mm 3 , who would otherwise have required further investigation. However, even in this group sensitivity was modest. Future and adequately powered studies in a primary care setting should now specifically target patients with suspected TB who have advanced HIV infection. DA - 2010 DB - OpenUCT DO - 10.1371/journal.pone.0009848 DP - University of Cape Town J1 - PLoS One LK - https://open.uct.ac.za PB - University of Cape Town PY - 2010 T1 - Clinical utility of a commercial LAM-ELISA assay for TB diagnosis in HIV-infected patients using urine and sputum samples TI - Clinical utility of a commercial LAM-ELISA assay for TB diagnosis in HIV-infected patients using urine and sputum samples UR - http://hdl.handle.net/11427/16255 ER - en_ZA
dc.identifier.urihttp://hdl.handle.net/11427/16255
dc.identifier.urihttp://dx.doi.org/10.1371/journal.pone.0009848
dc.identifier.vancouvercitationDheda K, Davids V, Lenders L, Roberts T, Meldau R, Ling D, et al. Clinical utility of a commercial LAM-ELISA assay for TB diagnosis in HIV-infected patients using urine and sputum samples. PLoS One. 2010; http://hdl.handle.net/11427/16255.en_ZA
dc.language.isoengen_ZA
dc.publisherPublic Library of Scienceen_ZA
dc.publisher.departmentDivision of Pulmonologyen_ZA
dc.publisher.facultyFaculty of Health Sciencesen_ZA
dc.publisher.institutionUniversity of Cape Town
dc.rightsThis is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.en_ZA
dc.rights.holder© 2010 Dheda et alen_ZA
dc.rights.urihttp://creativecommons.org/licenses/by/4.0en_ZA
dc.sourcePLoS Oneen_ZA
dc.source.urihttp://journals.plos.org/plosoneen_ZA
dc.subject.otherUrineen_ZA
dc.subject.otherTuberculosisen_ZA
dc.subject.otherSputumen_ZA
dc.subject.otherHIVen_ZA
dc.subject.otherTuberculosis diagnosis and managementen_ZA
dc.subject.otherDiagnostic medicineen_ZA
dc.subject.otherPrimary careen_ZA
dc.subject.otherMycobacterium tuberculosisen_ZA
dc.titleClinical utility of a commercial LAM-ELISA assay for TB diagnosis in HIV-infected patients using urine and sputum samplesen_ZA
dc.typeJournal Articleen_ZA
uct.type.filetypeText
uct.type.filetypeImage
uct.type.publicationResearchen_ZA
uct.type.resourceArticleen_ZA
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