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

 

Show simple item record

dc.contributor.author Lawn, Stephen en_ZA
dc.contributor.author Dheda, Keertan en_ZA
dc.contributor.author Kerkhoff, Andrew en_ZA
dc.contributor.author Peter, Jonathan en_ZA
dc.contributor.author Dorman, Susan en_ZA
dc.contributor.author Boehme, Catharina en_ZA
dc.contributor.author Nicol, Mark en_ZA
dc.date.accessioned 2015-10-28T06:50:49Z
dc.date.available 2015-10-28T06:50:49Z
dc.date.issued 2013 en_ZA
dc.identifier.citation Lawn, 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.uri http://hdl.handle.net/11427/14427
dc.identifier.uri http://dx.doi.org/10.1186/1471-2334-13-407
dc.description.abstract 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. en_ZA
dc.language.iso eng en_ZA
dc.publisher BioMed Central Ltd en_ZA
dc.rights This is an open access article distributed under the terms of the Creative Commons Attribution License en_ZA
dc.rights.uri http://creativecommons.org/licenses/by/2.0 en_ZA
dc.source BMC Infectious Diseases en_ZA
dc.source.uri http://www.biomedcentral.com/bmcinfectdis/ en_ZA
dc.subject.other Determine TB-LAM Ag en_ZA
dc.subject.other Lipoarabinomannan en_ZA
dc.subject.other Tuberculosis en_ZA
dc.subject.other Diagnostic accuracy en_ZA
dc.subject.other Point-of-care en_ZA
dc.title Determine TB-LAM lateral flow urine antigen assay for HIV-associated tuberculosis: recommendations on the design and reporting of clinical studies en_ZA
dc.type Journal Article en_ZA
dc.rights.holder 2013 Lawn et al.; licensee BioMed Central Ltd en_ZA
uct.type.publication Research en_ZA
uct.type.resource Article en_ZA
dc.publisher.institution University of Cape Town
dc.publisher.faculty Faculty of Health Sciences en_ZA
dc.publisher.department Desmond Tutu HIV Centre en_ZA
uct.type.filetype Text
uct.type.filetype Image


Files in this item

This item appears in the following Collection(s)

Show simple item record

This is an open access article distributed under the terms of the Creative Commons Attribution License Except where otherwise noted, this item's license is described as This is an open access article distributed under the terms of the Creative Commons Attribution License