title: The patient impact of point-of-care vs. laboratory placement of Xpert(®) MTB/RIF.
abstract: BACKGROUND
  The Xpert(®) MTB/RIF assay can diagnose tuberculosis (TB) rapidly and with great accuracy. The effect of Xpert placement at point of care (POC) vs. at an off-site laboratory on patient management remains unknown.
  
  
  METHODS
  At a primary care clinic in Johannesburg, South Africa, we compared TB diagnosis and treatment initiation among 1861 individuals evaluated for pulmonary TB using Xpert performed either at POC or offsite.
  
  
  RESULTS
  When Xpert was performed at POC, a higher proportion of Xpert-positive individuals started treatment (95% vs. 87%, P = 0.047) and time to treatment initiation was shorter (median 0 vs. 5 days, P < 0.001). In contrast, among Xpert-negative TB cases, a higher proportion (87% vs. 72%, P = 0.001) started treatment when the sample was sent to the laboratory, with a shorter time to treatment (median 9 vs. 13 days, P = 0.056). While the overall proportion of presumed TB patients starting treatment was independent of Xpert placement, the proportion started based on a bacteriologically confirmed diagnosis was higher when Xpert was performed at POC (73% vs. 58%, P = 0.006).
  
  
  CONCLUSIONS
  Placement of Xpert at POC resulted in more Xpert-positive patients receiving treatment, but did not increase the total number of presumed TB patients starting treatment. When samples were sent to a laboratory for Xpert testing, empiric decision making increased.
authors.affiliation: Department of Epidemiology, University of North Carolina Gillings School of Global Public Health, Chapel Hill, North Carolina, USA.
authors.forename: C F
authors.initials: CF
authors.lastname: Hanrahan
authors.affiliation: Vanderbilt Institute for Global Health, Vanderbilt University, Nashville, Tennessee, USA.
authors.forename: K
authors.initials: K
authors.lastname: Clouse
authors.affiliation: Witkoppen Health and Welfare Centre, Johannesburg, South Africa.
authors.forename: J
authors.initials: J
authors.lastname: Bassett
authors.affiliation: Witkoppen Health and Welfare Centre, Johannesburg, South Africa.
authors.forename: L
authors.initials: L
authors.lastname: Mutunga
authors.affiliation: Clinical HIV Research Unit, Johannesburg, South Africa.
authors.forename: K
authors.initials: K
authors.lastname: Selibas
authors.affiliation: Department of Molecular Medicine and Haematology, University of the Witwatersrand, Johannesburg, South Africa; The National Health Laboratory Service, Johannesburg, South Africa.
authors.forename: W
authors.initials: W
authors.lastname: Stevens
authors.affiliation: The National Health Laboratory Service, Johannesburg, South Africa.
authors.forename: L
authors.initials: L
authors.lastname: Scott
authors.affiliation: Clinical HIV Research Unit, Johannesburg, South Africa.
authors.forename: I
authors.initials: I
authors.lastname: Sanne
authors.affiliation: Department of Epidemiology, University of North Carolina Gillings School of Global Public Health, Chapel Hill, North Carolina, USA.
authors.forename: A
authors.initials: A
authors.lastname: Van Rie
mesh_terms: D000328:Adult; D018791:CD4 Lymphocyte Count; D005260:Female; D015658:HIV Infections / Q000150:complications*; D006801:Humans; D007753:Laboratories / Q000706:statistics & numerical data*; D008297:Male; D008875:Middle Aged; D009169:Mycobacterium tuberculosis / Q000302:isolation & purification*; D019095:Point-of-Care Systems / Q000706:statistics & numerical data*; D011320:Primary Health Care; D016016:Proportional Hazards Models; D011446:Prospective Studies; D013019:South Africa; D013183:Sputum / Q000382:microbiology*; D061665:Time-to-Treatment / Q000706:statistics & numerical data*; D014397:Tuberculosis, Pulmonary / Q000175:diagnosis*