Diagnostic Accuracy of a Point-of-Care Urine Test for Tuberculosis Screening Among Newly-Diagnosed HIV-Infected Adults: A Prospective, Clinic-Based Study
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Author
Drain, Paul K.
Coleman, Sharon M.
Giddy, Janet
Ross, Douglas
Published Version
https://doi.org/10.1186/1471-2334-14-110Metadata
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Drain, Paul K., Elena Losina, Sharon M. Coleman, Janet Giddy, Douglas Ross, Jeffrey Katz, Rochelle Walensky et al. "Diagnostic Accuracy of a Point-of-Care Urine Test for Tuberculosis Screening Among Newly-Diagnosed HIV-Infected Adults: A Prospective, Clinic-Based Study." BMC Infectious Diseases 14, no. 1 (2014): 110. DOI: 10.1186/1471-2334-14-110Abstract
BackgroundA rapid diagnostic test for active tuberculosis (TB) at the clinical point-of-care could expedite case detection and accelerate TB treatment initiation. We assessed the diagnostic accuracy of a rapid urine lipoarabinomannan (LAM) test for TB screening among HIV-infected adults in a TB-endemic setting.
Methods
We prospectively enrolled newly-diagnosed HIV-infected adults (≥18 years) at 4 outpatient clinics in Durban from Oct 2011-May 2012, excluding those on TB therapy. A physician evaluated all participants and offered CD4 cell count testing. Trained study nurses collected a sputum sample for acid-fast bacilli smear microscopy (AFB) and mycobacterial culture, and performed urine LAM testing using Determine™ TB LAM in the clinic. The presence of a band regardless of intensity on the urine LAM test was considered positive. We defined as the gold standard for active pulmonary TB a positive sputum culture for Mycobacterium tuberculosis. Diagnostic accuracy of urine LAM was assessed, alone and in combination with smear microscopy, and stratified by CD4 cell count.
Results
Among 342 newly-diagnosed HIV-infected participants, 190 (56%) were male, mean age was 35.6 years, and median CD4 was 182/mm3. Sixty participants had culture-positive pulmonary TB, resulting in an estimated prevalence of 17.5% (95% CI 13.7-22.0%). Forty-five (13.2%) participants were urine LAM positive. Mean time from urine specimen collection to LAM test result was 40 minutes (95% CI 34–46 minutes). Urine LAM test sensitivity was 28.3% (95% CI 17.5-41.4) overall, and 37.5% (95% CI 21.1-56.3) for those with CD4 count <100/mm3, while specificity was 90.1% (95% CI 86.0-93.3) overall, and 86.9% (95% CI 75.8-94.2) for those with CD4 < 100/mm3. When combined with sputum AFB (either test positive), sensitivity increased to 38.3% (95% CI 26.0-51.8), but specificity decreased to 85.8% (95% CI 81.1-89.7).
Conclusions
In this prospective, clinic-based study with trained nurses, a rapid urine LAM test had low sensitivity for TB screening among newly-diagnosed HIV-infected adults, but improved sensitivity when combined with sputum smear microscopy.
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https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3944827/Terms of Use
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https://nrs.harvard.edu/URN-3:HUL.INSTREPOS:37372855
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