Abstract
BackgroundWorld Health Organization (WHO) recommends tuberculosis (TB) screening at HIV diagnosis. We evaluated the inclusion of rapid urine lipoarabinomannan (LAM) testing in TB screening algorithms.MethodsWe enrolled ART-naïve adults who screened HIV-infected in KwaZulu-Natal, assessed TB-related symptoms (cough, fever, night sweats, weight loss), and obtained sputum specimens for mycobacterial culture. Trained nurses performed clinic-based urine LAM testing using a rapid assay. We used diagnostic accuracy, negative predictive value (NPV), and negative likelihood ratio, stratified by CD4 count, to evaluate screening for culture-positive TB.ResultsAmong 675 HIV-infected adults with median CD4 of 213/mm3 (interquartile range 85-360/mm3), 123 (18%) had culture-confirmed pulmonary TB. The WHO-recommended algorithm of any TB-related symptom had a sensitivity of 77% [95% confidence interval (CI) 69-84%] and NPV of 89% (95% CI 84-92%) for identifying active pulmonary TB. Including the LAM assay improved sensitivity (83%; 95% CI 75-89%) and NPV (91%; 95% CI 86-94%), while decreasing the negative likelihood ratio (0.45 versus 0.57). Among participants with CD4 < 100/mm3, including urine LAM testing improved the negative predictive value of symptom based screening from 83% to 87%. All screening algorithms with urine LAM performed better among participants with CD4 < 100/mm3, compared to those with CD4 ≥ 100/mm3.ConclusionClinic-based urine LAM screening increased the sensitivity of symptom-based screening by 6% among ART-naïve HIV-infected adults in a TB-endemic setting, thereby providing marginal benefit.
Highlights
World Health Organization (WHO) recommends tuberculosis (TB) screening at HIV diagnosis
In two clinic-based studies, we demonstrated that the rapid urine LAM assay had poor overall diagnostic sensitivity (28-41%) to be used as a stand-alone TB screening test at HIV diagnosis [13, 14]
[17] since the rapid LAM assay can be performed by nurses in a clinic [13, 14], we sought to determine if urine LAM testing might augment symptom-based TB screening at HIV diagnosis in a high TB-endemic region of South Africa
Summary
World Health Organization (WHO) recommends tuberculosis (TB) screening at HIV diagnosis. In 2006, the World Health Organization (WHO) suggested systematic screening for active TB in HIV-infected adults by assessing the presence of a cough for at least two weeks [3]. In two clinic-based studies, we demonstrated that the rapid urine LAM assay had poor overall diagnostic sensitivity (28-41%) to be used as a stand-alone TB screening test at HIV diagnosis [13, 14]. [17] since the rapid LAM assay can be performed by nurses in a clinic [13, 14], we sought to determine if urine LAM testing might augment symptom-based TB screening at HIV diagnosis in a high TB-endemic region of South Africa With similar results from another outpatient screening study [15, 16], the WHO recently recommended against using the urine LAM assay as a TB screening test. [17] since the rapid LAM assay can be performed by nurses in a clinic [13, 14], we sought to determine if urine LAM testing might augment symptom-based TB screening at HIV diagnosis in a high TB-endemic region of South Africa
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