title: Adding value to antiretroviral proficiency testing.
abstract: BACKGROUND
  Clinical trial specimens tested for antiretroviral (ARV) concentrations often require compliance with Clinical Laboratory Improvement Act and/or the Food and Drug Administration bioanalytical guidance.
  
  
  METHODS
  The Clinical Pharmacology Quality Assurance Program (CPQA) designed 8 proficiency testing (PT) rounds over 4 years to assess precision, specificity and stability.
  
  
  RESULTS
  Ten laboratories provided blinded proficiency data to support continued acceptable precision of ARV methods. Specificity samples identified little bias for individual methods; hemolyzed (87%) and lipemic (86%) results were ≤ 10% of their control results. Stability was established for ARVs in plasma at -70°C for 2.5-3.6 years.
  
  
  CONCLUSIONS
  PT provided by the CPQA assured continued acceptability of individual laboratory assay performances for precision and specificity, and obtained ARV stability during long term storage.
authors.affiliation: HIV Clinical Pharmacology Research Program, Translational Pharmacology Research Core, New York State Center of Excellence in Bioinformatics & Life Sciences; School of Pharmacy & Pharmaceutical Sciences, University at Buffalo, Buffalo, NY USA.
authors.forename: Robin
authors.initials: R
authors.lastname: DiFrancesco
authors.forename: Charlene R
authors.initials: CR
authors.lastname: Taylor
authors.forename: Susan L
authors.initials: SL
authors.lastname: Rosenkranz
authors.forename: Kelly M
authors.initials: KM
authors.lastname: Tooley
authors.forename: Poonam G
authors.initials: PG
authors.lastname: Pande
authors.forename: Suzanne M
authors.initials: SM
authors.lastname: Siminski
authors.forename: Richard W
authors.initials: RW
authors.lastname: Jenny
authors.forename: Gene D
authors.initials: GD
authors.lastname: Morse
mesh_terms: D006801:Humans; D059021:Laboratory Proficiency Testing / Q000379:methods*; D011786:Quality Control