title: Rapid urine lipoarabinomannan assay as a clinic-based screening test for active tuberculosis at HIV diagnosis.
abstract: World Health Organization (WHO) recommends tuberculosis (TB) screening at HIV diagnosis. We evaluated the inclusion of rapid urine lipoarabinomannan (LAM) testing in TB screening algorithms.
  
  
  
  We enrolled ART-naïve adults who screened HIV-infected in KwaZulu-Natal, assessed TB-related symptoms (cough, fever, night sweats, weight loss), and obtained sputum specimens for mycobacterial culture. Trained nurses performed clinic-based urine LAM testing using a rapid assay. We used diagnostic accuracy, negative predictive value (NPV), and negative likelihood ratio, stratified by CD4 count, to evaluate screening for culture-positive TB.
  
  
  
  Among 675 HIV-infected adults with median CD4 of 213/mm3(interquartile range 85-360/mm3), 123 (18%) had culture-confirmed pulmonary TB. The WHO-recommended algorithm of any TB-related symptom had a sensitivity of 77% [95% confidence interval (CI) 69-84%] and NPV of 89% (95% CI 84-92%) for identifying active pulmonary TB. Including the LAM assay improved sensitivity (83%; 95% CI 75-89%) and NPV (91%; 95% CI 86-94%), while decreasing the negative likelihood ratio (0.45 versus 0.57). Among participants with CD4 < 100/mm3, including urine LAM testing improved the negative predictive value of symptom based screening from 83% to 87%. All screening algorithms with urine LAM performed better among participants with CD4 < 100/mm3, compared to those with CD4 ≥ 100/mm3.
  
  
  
  Clinic-based urine LAM screening increased the sensitivity of symptom-based screening by 6% among ART-naïve HIV-infected adults in a TB-endemic setting, thereby providing marginal benefit.
authors.affiliation: Department of Global Health, University of Washington, 325 Ninth Ave, UW Box 359927, Seattle, WA, 98104-2420, USA. pkdrain@uw.edu.|Department of Medicine, University of Washington, Seattle, WA, USA. pkdrain@uw.edu.|Department of Epidemiology, University of Washington, Seattle, WA, USA. pkdrain@uw.edu.|Department of Surgery, Massachusetts General Hospital, Harvard Medical School, Boston, USA. pkdrain@uw.edu.
authors.forename: Paul K
authors.initials: PK
authors.lastname: Drain
authors.affiliation: Medical Practice Evaluation Center, Harvard Medical School, Boston, USA.|Division of General Internal Medicine, Harvard Medical School, Boston, USA.|Department of Orthopedic Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, USA.
authors.forename: Elena
authors.initials: E
authors.lastname: Losina
authors.affiliation: Boston University School of Public Health, Boston, USA.
authors.forename: Sharon M
authors.initials: SM
authors.lastname: Coleman
authors.affiliation: Department of Medicine, McCord Hospital, Durban, South Africa.
authors.forename: Janet
authors.initials: J
authors.lastname: Giddy
authors.affiliation: Department of Medicine, St. Mary's Hospital, Durban, South Africa.
authors.forename: Douglas
authors.initials: D
authors.lastname: Ross
authors.affiliation: Department of Orthopedic Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, USA.
authors.forename: Jeffrey N
authors.initials: JN
authors.lastname: Katz
authors.affiliation: Medical Practice Evaluation Center, Harvard Medical School, Boston, USA.|Division of Infectious Diseases, Harvard Medical School, Boston, USA.|Division of General Internal Medicine, Harvard Medical School, Boston, USA.
authors.forename: Ingrid V
authors.initials: IV
authors.lastname: Bassett
mesh_terms: D000328:Adult; D000465:Algorithms; D018791:CD4 Lymphocyte Count; D005260:Female; D015658:HIV Infections / Q000150:complications*; D006801:Humans; D008070:Lipopolysaccharides / Q000652:urine*; D008297:Male; D008403:Mass Screening / Q000379:methods*; D009169:Mycobacterium tuberculosis / Q000302:isolation & purification*; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D013019:South Africa; D013183:Sputum / Q000382:microbiology; D014397:Tuberculosis, Pulmonary / Q000175:diagnosis*; D055815:Young Adult
chemical_list: D008070:Lipopolysaccharides; C050016:lipoarabinomannan
keywords: Diagnostic screening; HIV/AIDS; Lipoarabinomannan (LAM); South Africa; Tuberculosis; Urine