title: Prospective Aspergillus galactomannan antigen testing in pediatric hematopoietic stem cell transplant recipients.
abstract: BACKGROUND
  The galactomannan (GM) assay is an approved noninvasive test for detection of invasive aspergillosis (IA) that has been validated in adult patients with hematologic malignancies who are undergoing bone marrow transplantation. There have been few studies with this assay in pediatric patients, but early reports suggest that there may be differences in the performance such that false-positive GM tests in pediatric patients are more common than in adult patients.
  
  
  METHODS
  We performed a prospective study in pediatric hematopoietic stem cell transplant recipients with twice-weekly sampling for GM detection during the highest risk periods of neutropenia and graft-versus-host disease. We analyzed 826 serum samples from 64 patients, including 15 serum samples from one patient diagnosed with probable IA according to defined criteria.
  
  
  RESULTS
  Twenty of 811 samples tested positive on repeat testing (specificity, 97.5%; 95% CI: 96.2-98.4%) including samples from 8 of 63 patients without clinical evidence of IA according to study criteria (specificity, 87.3%; 95% CI: 76.9-93.4%). Eleven patients received piperacillin/tazobactam therapy, and 4 of the 11 patients had a positive assay result coinciding with the dates of piperacillin/tazobactam administration. When samples from these patients were excluded, specificity increased to 98.4% (95% CI: 97.2-99.1%) by sample and to 91.5% (95% CI: 81.6-96.3%) by patient.
  
  
  CONCLUSIONS
  The GM assay holds promise for early, noninvasive diagnosis of IA in high-risk children and false-positive results were not common or unexplainable. This study supports further validation of this assay in a large-scale, pediatric-dedicated format.
authors.affiliation: Department of Pediatrics, Duke University Medical Center, Durham, NC 27710, USA. stein022@mc.duke.edu
authors.forename: William J
authors.initials: WJ
authors.lastname: Steinbach
authors.forename: Rachel M
authors.initials: RM
authors.lastname: Addison
authors.forename: Lisa
authors.initials: L
authors.lastname: McLaughlin
authors.forename: Quincy
authors.initials: Q
authors.lastname: Gerrald
authors.forename: Paul L
authors.initials: PL
authors.lastname: Martin
authors.forename: Timothy
authors.initials: T
authors.lastname: Driscoll
authors.forename: Christopher
authors.initials: C
authors.lastname: Bentsen
authors.forename: John R
authors.initials: JR
authors.lastname: Perfect
authors.forename: Barbara D
authors.initials: BD
authors.lastname: Alexander
mesh_terms: D000946:Antigens, Fungal / Q000276:immunology*; D001228:Aspergillosis / Q000175:diagnosis; D001230:Aspergillus / Q000302:isolation & purification*; D002648:Child; D004797:Enzyme-Linked Immunosorbent Assay; D005690:Galactose / Q000031:analogs & derivatives; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D008351:Mannans / Q000302:isolation & purification*; D011237:Predictive Value of Tests; D012680:Sensitivity and Specificity
chemical_list: D000946:Antigens, Fungal; D008351:Mannans; C012990:galactomannan; D005690:Galactose