Utility of novel diagnostic tests for tuberculosis using human urine

Master Thesis

2012

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University of Cape Town

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Two thirds of new TB cases in sub-Saharan Africa are HIV coinfected. HIV-TB co-infection increases the incidence of extra-pulmonary, sputum smear-negative and sputum-scarce TB. In these vulnerable patientgroups with high mortality rates, sputum-based diagnostic tools are unhelpful. Urine-based diagnostics offer an attractive, easily available alternative for rapid diagnosis. We evaluated the point-of-care urine LAM strip test (Determine TB LAM Ag test, Alere) and urine-based Xpert MTB/RIF for TB diagnosis in two patient cohorts with high HIV prevalence. A spot urine sample was collected from two cohorts of persons with suspected TB. The first cohort consisted of ambulatory primary care clinic patients suspected of having TB (group 1) whilst the second comprised hospitalised patients with suspected HIV co-infection (group 2). The urine LAM ELISA, LAM strip test and Xpert MTB/RIF were performed according to the manufacturer’s instructions. In addition, the effects of using an alternative ‘rulein’ cut-point for the urine LAM strip test and a pelleted (2-10ml) urine sample for Xpert MTB/RIF testing on diagnostic accuracy and inter-reader reliability was assessed. The diagnostic reference standard was M. tuberculosis culture positivity.
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