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. 2016 Nov 14;16(1):147.
doi: 10.1186/s12890-016-0316-z.

Rapid urine lipoarabinomannan assay as a clinic-based screening test for active tuberculosis at HIV diagnosis

Paul K Drain  1   2   3   4 , Elena Losina  5   6   7 , Sharon M Coleman  8 , Janet Giddy  9 , Douglas Ross  10 , Jeffrey N Katz  7 , Ingrid V Bassett  5   11   6
Affiliations

Rapid urine lipoarabinomannan assay as a clinic-based screening test for active tuberculosis at HIV diagnosis

Paul K Drain et al. BMC Pulm Med. .

Abstract

Background: World Health Organization (WHO) recommends tuberculosis (TB) screening at HIV diagnosis. We evaluated the inclusion of rapid urine lipoarabinomannan (LAM) testing in TB screening algorithms.

Methods: We 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.

Results: Among 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.

Conclusion: Clinic-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.

Keywords: Diagnostic screening; HIV/AIDS; Lipoarabinomannan (LAM); South Africa; Tuberculosis; Urine.

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Figures

Fig. 1
Fig. 1
Pre- and post-test probabilities for various screening algorithms for HIV-infected populations with TB prevalence of 5%, 10%, and 20%
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