title: Factors affecting urine reagent strip blood results in dogs and nonhuman primates and interpretation of urinalysis in preclinical toxicology studies: a Multi-Institution Contract Research Organization and BioPharmaceutical Company Perspective.
abstract: BACKGROUND
  Urinalysis data in preclinical toxicology studies can be influenced by preanalytic and analytic factors which have the potential to confound interpretation. There is a paucity of information regarding positive reagent strip urinary blood reactions in healthy nonhuman primates (NHP) and Beagle dogs used in preclinical toxicology studies.
  
  
  OBJECTIVE
  The objectives were (1) to establish historical control data for reagent strip urinary blood reactions in healthy NHP and Beagle dogs, (2) to determine the incidence of positive urinary blood reactions during predose and dosing phases, and (3) to determine if collection practice was a relevant parameter.
  
  
  METHODS
  Historical control data from 2 institutions in the biopharmaceutical industry were retrospectively analyzed for reagent strip urinary blood reactions in healthy NHP and Beagles. The incidence of positive results between the 2 institutions with different urine collection practices and between males and females was compared.
  
  
  RESULTS
  The incidence of positive urinary blood reactions in NHP was comparable between institutions (≤ 14% in males; ≤ 33% in females), while the incidence of positive urinary blood reactions in Beagles was more variable (≤ 77% in males; ≤ 69% in females), and higher in females during the dosing phase.
  
  
  CONCLUSIONS
  Positive urinary blood results that could potentially be misinterpreted as toxicologically relevant were identified in healthy NHP and Beagles during predose and dosing phases. Different incidences of positive results between the 2 institutions were likely related to collection practices. Strategies to reduce feces and food contamination of collected urine samples should help minimize false-positive urinary blood reactions.
authors.affiliation: MPI Research, Mattawan, MI, USA.
authors.forename: Adam D
authors.initials: AD
authors.lastname: Aulbach
authors.affiliation: Department of Pathology, Lilly Research Laboratories, A Division of Eli Lilly and Company, Indianapolis, IN, USA.
authors.forename: Eric
authors.initials: E
authors.lastname: Schultze
authors.affiliation: Covance Laboratories Inc., Madison, WI, USA.
authors.forename: Niraj K
authors.initials: NK
authors.lastname: Tripathi
authors.affiliation: Covance Laboratories Inc., Madison, WI, USA.
authors.forename: Robert L
authors.initials: RL
authors.lastname: Hall
authors.affiliation: Covance Laboratories Inc., Madison, WI, USA.
authors.forename: Michael R
authors.initials: MR
authors.lastname: Logan
authors.affiliation: Charles River Laboratories, Reno, NV, USA.
authors.forename: Denny J
authors.initials: DJ
authors.lastname: Meyer
mesh_terms: D000818:Animals; D004283:Dog Diseases / Q000175:diagnosis / Q000652:urine*; D004285:Dogs / Q000652:urine*; D005260:Female; D006417:Hematuria / Q000175:diagnosis / Q000662:veterinary*; D008297:Male; D011323:Primates / Q000652:urine*; D011934:Reagent Strips; D016482:Urinalysis / Q000379:methods / Q000662:veterinary*; D014556:Urine
chemical_list: D011934:Reagent Strips
keywords: False-positive test results; preanalytic factors; urinalysis