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. 2009 Oct;13(10):1253-9.

Diagnostic accuracy of commercial urinary lipoarabinomannan detection in African tuberculosis suspects and patients

R Mutetwa  1 , C Boehme, M Dimairo, T Bandason, S S Munyati, D Mangwanya, S Mungofa, A E Butterworth, P R Mason, E L Corbett
Affiliations

Diagnostic accuracy of commercial urinary lipoarabinomannan detection in African tuberculosis suspects and patients

R Mutetwa et al. Int J Tuberc Lung Dis. 2009 Oct.

Abstract

Objective: To evaluate a commercially available antigen capture enzyme-linked immunosorbent assay (ELISA) based on detecting lipoarabinomannan (LAM) in urine for the diagnosis of tuberculosis (TB).

Design: Consenting TB suspects and registering TB patients prospectively recruited from three hospitals were asked for two sputum specimens for microscopy and culture, urine for LAM testing and blood for human immunodeficiency virus (HIV) testing, with radiological and clinical follow-up for 2 months.

Results: Of 427 participants, complete data were available from 397 (307 adult and 23 adolescent TB suspects, and 67 registering TB patients). HIV prevalence was 77%. TB was diagnosed in 195 (49%), including 161 culture-positive patients, and confidently excluded in 114 (29%) participants. LAM ELISA sensitivity was 44% (95%CI 36-52) for culture-confirmed TB (52% in smear-positive patients). Specificity was 89% (95%CI 81-94). Sensitivity was significantly higher in HIV-related TB (52%, 95%CI 43-62, P < 0.001) compared to HIV-negative TB (21%, 95%CI 9-37). Sensitivity in smear-negative patients was low (28%, 95%CI 13-43) for combined HIV-positive and -negative patients.

Conclusion: Our findings confirm greater sensitivity of urine LAM detection for HIV-related TB. However, both sensitivity and specificity were suboptimal, suggesting that this version cannot confirm or exclude TB in either HIV-infected or non-infected patients.

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Figures

FIGURE 1
FIGURE 1. Participant flow chart
Of 427 recruited TB patients and suspects, 30 were excluded and 397 patients were tested with chemogen, and 88 patients were TB indeterminate by smear, culture and clinical follow-up. The Chemogen sensitivity and specificity is given for the TB and non-TB patient groups with the corresponding 95%CI. Where: S+ve: Sputum smear positive for acid fast bacilli; S-ve: Sputum smear negative for acid fast bacilli; C+ve: Sputum culture positive for Mycobacterium tuberculosis; C-ve: Sputum culture negative for Mycobacterium tuberculosis
FIGURE 2
FIGURE 2. Chemogen LAM sensitivity in TB patients by smear and culture status
Chemogen test sensitivity shown by the box and the corresponding 95%CI in the culture confirmed TB group by smear status and in the clinical TB patient group diagnosed through radiograph and clinical follow-up with response to TB treatment at 1 month.
See this image and copyright information in PMC

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