title: Diagnostic accuracy of a rapid urine lipoarabinomannan test for tuberculosis in HIV-infected adults.
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.
  
  
  METHODS
  Prospective diagnostic accuracy study.
  
  
  METHODS
  Hospital and outpatient settings in Uganda and South Africa.
  
  
  METHODS
  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.
  
  
  METHODS
  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 culture-positive 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.
authors.affiliation: *Department of Medicine, Infectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda; †Division of Medical Microbiology, University of Cape Town, Cape Town, South Africa and National Health Laboratory Service, South Africa; ‡Johns Hopkins University School of Medicine, Baltimore, MD; §Department of Medicine, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD; ‖Department of Medical Microbiology, College of Health Sciences, Makerere University, Kampala, Uganda; ¶Division of Infectious Diseases, Department of Medicine, New Jersey Medical School, Newark, NJ; and #Department of Medicine, Boston Medical Center, Boston University, Boston, MA.
authors.forename: Lydia
authors.initials: L
authors.lastname: Nakiyingi
authors.forename: Vineshree Mischka
authors.initials: VM
authors.lastname: Moodley
authors.forename: Yukari C
authors.initials: YC
authors.lastname: Manabe
authors.forename: Mark P
authors.initials: MP
authors.lastname: Nicol
authors.forename: Molly
authors.initials: M
authors.lastname: Holshouser
authors.forename: Derek T
authors.initials: DT
authors.lastname: Armstrong
authors.forename: Widaad
authors.initials: W
authors.lastname: Zemanay
authors.forename: Welile
authors.initials: W
authors.lastname: Sikhondze
authors.forename: Olive
authors.initials: O
authors.lastname: Mbabazi
authors.forename: Bareng A S
authors.initials: BA
authors.lastname: Nonyane
authors.forename: Maunank
authors.initials: M
authors.lastname: Shah
authors.forename: Moses L
authors.initials: ML
authors.lastname: Joloba
authors.forename: David
authors.initials: D
authors.lastname: Alland
authors.forename: Jerrold J
authors.initials: JJ
authors.lastname: Ellner
authors.forename: Susan E
authors.initials: SE
authors.lastname: Dorman
mesh_terms: D017088:AIDS-Related Opportunistic Infections / Q000175:diagnosis*; D000328:Adult; D001431:Bacteriological Techniques / Q000379:methods; D003955:Diagnostic Tests, Routine / Q000592:standards*; D005260:Female; D015658:HIV Infections / Q000150:complications* / Q000382:microbiology; D006801:Humans; D008070:Lipopolysaccharides / Q000652:urine*; D008297:Male; D008875:Middle Aged; D019095:Point-of-Care Systems / Q000592:standards; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D014376:Tuberculosis / Q000652:urine*
chemical_list: D008070:Lipopolysaccharides; C050016:lipoarabinomannan