Determine TB-LAM lateral flow urine antigen assay for HIV-associated tuberculosis: recommendations on the design and reporting of clinical studies

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dc.contributor.authorLawn, Stephenen_ZA
dc.contributor.authorDheda, Keertanen_ZA
dc.contributor.authorKerkhoff, Andrewen_ZA
dc.contributor.authorPeter, Jonathanen_ZA
dc.contributor.authorDorman, Susanen_ZA
dc.contributor.authorBoehme, Catharinaen_ZA
dc.contributor.authorNicol, Marken_ZA
dc.date.accessioned2015-10-28T06:50:49Z
dc.date.available2015-10-28T06:50:49Z
dc.date.issued2013en_ZA
dc.description.abstractDetection of the Mycobacterium tuberculosis cell wall antigen lipoarabinomannan (LAM) in urine permits diagnoses of tuberculosis (TB) to be made in HIV-infected patients with advanced immunodeficiency. This can be achieved at the point-of-care within just 30 minutes using the Determine TB-LAM, which is a commercially available, lateral-flow urine 'strip test' assay. The assay has been shown to have useful diagnostic accuracy in patients enrolling in antiretroviral treatment services or in HIV-infected patients requiring admission to hospital medical wards in sub-Saharan Africa. Such patients have high mortality risk and have most to gain from rapid diagnosis of TB and immediate initiation of treatment. However, few studies using this assay have yet been reported and many questions remain concerning the correct use of the assay, interpretation of results, the role of the assay as an add-on test within existing diagnostic algorithms and the types of further studies needed. In this paper we address a series of questions with the aim of informing the design, conduct and interpretation of future studies. Specifically, we clarify which clinical populations are most likely to derive benefit from use of this assay and how patients enrolled in such studies might best be characterised. We describe the importance of employing a rigorous microbiological diagnostic reference standard in studies of diagnostic accuracy and discuss issues surrounding the specificity of the assay in different geographical areas and potential cross-reactivity with non-tuberculous mycobacteria and other organisms. We highlight the importance of careful procedures for urine collection and storage and the critical issue of how to read and interpret the test strips. Finally, we consider how the assay could be used in combination with other assays and outline the types of studies that are required to build the evidence base concerning its use.en_ZA
dc.identifier.apacitationLawn, S., Dheda, K., Kerkhoff, A., Peter, J., Dorman, S., Boehme, C., & Nicol, M. (2013). Determine TB-LAM lateral flow urine antigen assay for HIV-associated tuberculosis: recommendations on the design and reporting of clinical studies. <i>BMC Infectious Diseases</i>, http://hdl.handle.net/11427/14427en_ZA
dc.identifier.chicagocitationLawn, Stephen, Keertan Dheda, Andrew Kerkhoff, Jonathan Peter, Susan Dorman, Catharina Boehme, and Mark Nicol "Determine TB-LAM lateral flow urine antigen assay for HIV-associated tuberculosis: recommendations on the design and reporting of clinical studies." <i>BMC Infectious Diseases</i> (2013) http://hdl.handle.net/11427/14427en_ZA
dc.identifier.citationLawn, S. D., Dheda, K., Kerkhoff, A. D., Peter, J. G., Dorman, S., Boehme, C. C., & Nicol, M. P. (2013). Determine TB-LAM lateral flow urine antigen assay for HIV-associated tuberculosis: recommendations on the design and reporting of clinical studies. BMC infectious diseases, 13(1), 407.en_ZA
dc.identifier.ris TY - Journal Article AU - Lawn, Stephen AU - Dheda, Keertan AU - Kerkhoff, Andrew AU - Peter, Jonathan AU - Dorman, Susan AU - Boehme, Catharina AU - Nicol, Mark AB - Detection of the Mycobacterium tuberculosis cell wall antigen lipoarabinomannan (LAM) in urine permits diagnoses of tuberculosis (TB) to be made in HIV-infected patients with advanced immunodeficiency. This can be achieved at the point-of-care within just 30 minutes using the Determine TB-LAM, which is a commercially available, lateral-flow urine 'strip test' assay. The assay has been shown to have useful diagnostic accuracy in patients enrolling in antiretroviral treatment services or in HIV-infected patients requiring admission to hospital medical wards in sub-Saharan Africa. Such patients have high mortality risk and have most to gain from rapid diagnosis of TB and immediate initiation of treatment. However, few studies using this assay have yet been reported and many questions remain concerning the correct use of the assay, interpretation of results, the role of the assay as an add-on test within existing diagnostic algorithms and the types of further studies needed. In this paper we address a series of questions with the aim of informing the design, conduct and interpretation of future studies. Specifically, we clarify which clinical populations are most likely to derive benefit from use of this assay and how patients enrolled in such studies might best be characterised. We describe the importance of employing a rigorous microbiological diagnostic reference standard in studies of diagnostic accuracy and discuss issues surrounding the specificity of the assay in different geographical areas and potential cross-reactivity with non-tuberculous mycobacteria and other organisms. We highlight the importance of careful procedures for urine collection and storage and the critical issue of how to read and interpret the test strips. Finally, we consider how the assay could be used in combination with other assays and outline the types of studies that are required to build the evidence base concerning its use. DA - 2013 DB - OpenUCT DO - 10.1186/1471-2334-13-407 DP - University of Cape Town J1 - BMC Infectious Diseases LK - https://open.uct.ac.za PB - University of Cape Town PY - 2013 T1 - Determine TB-LAM lateral flow urine antigen assay for HIV-associated tuberculosis: recommendations on the design and reporting of clinical studies TI - Determine TB-LAM lateral flow urine antigen assay for HIV-associated tuberculosis: recommendations on the design and reporting of clinical studies UR - http://hdl.handle.net/11427/14427 ER - en_ZA
dc.identifier.urihttp://hdl.handle.net/11427/14427
dc.identifier.urihttp://dx.doi.org/10.1186/1471-2334-13-407
dc.identifier.vancouvercitationLawn S, Dheda K, Kerkhoff A, Peter J, Dorman S, Boehme C, et al. Determine TB-LAM lateral flow urine antigen assay for HIV-associated tuberculosis: recommendations on the design and reporting of clinical studies. BMC Infectious Diseases. 2013; http://hdl.handle.net/11427/14427.en_ZA
dc.language.isoengen_ZA
dc.publisherBioMed Central Ltden_ZA
dc.publisher.departmentDesmond Tutu HIV Centreen_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 Licenseen_ZA
dc.rights.holder2013 Lawn et al.; licensee BioMed Central Ltden_ZA
dc.rights.urihttp://creativecommons.org/licenses/by/2.0en_ZA
dc.sourceBMC Infectious Diseasesen_ZA
dc.source.urihttp://www.biomedcentral.com/bmcinfectdis/en_ZA
dc.subject.otherDetermine TB-LAM Agen_ZA
dc.subject.otherLipoarabinomannanen_ZA
dc.subject.otherTuberculosisen_ZA
dc.subject.otherDiagnostic accuracyen_ZA
dc.subject.otherPoint-of-careen_ZA
dc.titleDetermine TB-LAM lateral flow urine antigen assay for HIV-associated tuberculosis: recommendations on the design and reporting of clinical studiesen_ZA
dc.typeJournal Articleen_ZA
uct.type.filetypeText
uct.type.filetypeImage
uct.type.publicationResearchen_ZA
uct.type.resourceArticleen_ZA
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