Diagnostic accuracy of a rapid urine lipoarabinomannan test for tuberculosis in HIV-infected adults

Lydia Nakiyingi, Vineshree Mischka Moodley, Yukari C. Manabe, Mark P. Nicol, Molly Holshouser, Derek T. Armstrong, Widaad Zemanay, Welile Sikhondze, Olive Mbabazi, Bareng A.S. Nonyane, Maunank Shah, Moses L. Joloba, David Alland, Jerrold J. Ellner, Susan E. Dorman

Research output: Contribution to journalArticle

Abstract

Objective: In settings of high HIV prevalence, tuberculosis control and patient management are hindered by lack of accurate, rapid tuberculosis diagnostic tests that can be performed at point-of-care. The Determine TB LAM Ag (TB LAM) test is a lateral flow immunochromatographic test for detection of mycobacterial lipoarabinomannan (LAM) in urine. Our objective was to determine sensitivity and specificity of the TB LAM test for tuberculosis diagnosis. Design: Prospective diagnostic accuracy study. Setting: Hospital and outpatient settings in Uganda and South Africa. Participants: HIV-infected adults with tuberculosis symptoms and/or signs. Methods: Participants provided a fresh urine specimen for TB LAM testing, blood for mycobacterial culture, and 2 respiratory specimens for smear microscopy and mycobacterial culture. Main Outcome Measures: For the TB LAM test, sensitivity in participants with culture-positive tuberculosis and specificity in participants without tuberculosis. Results: A total of 1013 participants were enrolled. Among culturepositive tuberculosis patients, the TB LAM test identified 136/367 (37.1%) overall and 116/196 (59.2%) in the group with CD4 ≤100 cells per cubic millimeter. The test was specific in 559/573 (97.6%) patients without tuberculosis. Sensitivity of the urine TB LAM test plus sputum smear microscopy was 197/367 (53.7%) overall and 133/196 (67.9%) among those with CD4 ≤100. CD4 ≤50 [adjusted odds ratio (AOR), 6.2; P<0.001] or 51-100 (AOR, 7.1; P < 0.001), mycobacteremia (AOR, 6.1; P<0.01) and hospitalization (AOR, 2.6; P = 0.03) were independently associated with a positive TB LAM test. Conclusions: In HIV-positive adults with CD4 ≤100, the TB LAM urine test detected over half of culture-positive tuberculosis patients, in <30 minutes and without the need for equipment or reagents.

Original languageEnglish (US)
Pages (from-to)270-279
Number of pages10
JournalJournal of acquired immune deficiency syndromes
Volume66
Issue number3
DOIs
StatePublished - Jul 1 2014

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Keywords

  • Diagnosis
  • HIV
  • Opportunistic infections
  • Sensitivity and specificity
  • Tuberculosis

ASJC Scopus subject areas

  • Infectious Diseases
  • Pharmacology (medical)

Cite this

Nakiyingi, L., Moodley, V. M., Manabe, Y. C., Nicol, M. P., Holshouser, M., Armstrong, D. T., Zemanay, W., Sikhondze, W., Mbabazi, O., Nonyane, B. A. S., Shah, M., Joloba, M. L., Alland, D., Ellner, J. J., & Dorman, S. E. (2014). Diagnostic accuracy of a rapid urine lipoarabinomannan test for tuberculosis in HIV-infected adults. Journal of acquired immune deficiency syndromes, 66(3), 270-279. https://doi.org/10.1097/QAI.0000000000000151