Blinded evaluation of commercial urinary lipoarabinomannan for active tuberculosis: a pilot study
Abstract:SETTING: Urine antigen testing is an attractive strategy for the diagnosis of active tuberculosis (TB), but accuracy data are scarce.
OBJECTIVE: To prospectively evaluate the diagnostic performance of commercial urinary lipoarabinomannan (LAM) antigen testing for active TB among pulmonary and extra-pulmonary TB suspects.
DESIGN: Prospective blinded evaluation of 200 adult TB suspects at a tertiary referral hospital in India. Reference standards included culture and clinical diagnosis.
RESULTS: Patients were 61% male (mean age 40.4 years): 8.5% were human immunodeficiency virus (HIV) infected and 47 of 200 (23.5%) were culture-positive for TB. Compared to positivity on either Löwenstein-Jensen (LJ) or BACTEC cultures, LAM sensitivity was 17.8% (95%CI 8.5–32.6), while specificity was 87.7% (95%CI 81.3–92.3). Compared to positivity on both LJ and BACTEC, LAM sensitivity was 5.8% (95%CI 12.5–44.9), with a specificity of 88.8% (95%CI 82.7–92.9). Compared to the clinical diagnosis, LAM sensitivity was 20.0% (95%CI 1.1–70.1), with a specificity of 83.3% (95%CI 50.9–97.0). HIV and smear status did not influence test accuracy.
CONCLUSION: In its current form, LAM is insensitive for the diagnosis of active TB, although its specificity is adequate.
Document Type: Regular Paper
Affiliations: 1: Department of Medicine, Christian Medical College, Vellore, India 2: Department of Microbiology, Christian Medical College, Vellore, India 3: Department of Community Health, Christian Medical College, Vellore, India 4: Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Canada
Publication date: August 1, 2009
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