title: Assessment of DBS technology for the detection of therapeutic antibodies.
abstract: BACKGROUND
  Quantitating levels of therapeutic proteins in serum or plasma is critical for determining exposure levels and establishing pharmacokinetic parameters. Traditionally, whole blood is not used, mostly due to its inability to be frozen and potential issues with assay interference. To investigate the ability to reproducibly quantitate therapeutic antibodies present in dried blood spots (DBS) compared with a typical serum sample-based method, we used ELISA and electrochemiluminescence immunoassays to measure therapeutic drug levels present in DBS samples.
  
  
  RESULTS
  Measurements of antibody therapeutics in DBS were reproducible, yielding methods that are precise, accurate and met expected sensitivity requirements compared with plasma-based methods.
  
  
  CONCLUSIONS
  DBS are a viable alternative to the use of conventional serum or plasma samples for quantitative therapeutic antibody measures.
authors.affiliation: Pharmacokinetics and Drug Metabolism (PKDM), Amgen Inc., 1201 Amgen Court West, Seattle, Washington, USA. princep@amgen.com
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Prince
authors.forename: Katherine C
authors.initials: KC
authors.lastname: Matsuda
authors.forename: Mw
authors.initials: M
authors.lastname: Retter
authors.forename: G
authors.initials: G
authors.lastname: Scott
mesh_terms: D000818:Animals; D000906:Antibodies / Q000097:blood* / Q000276:immunology / Q000627:therapeutic use*; D001774:Blood Chemical Analysis / Q000379:methods*; D001800:Blood Specimen Collection / Q000379:methods*; D003890:Desiccation; D004797:Enzyme-Linked Immunosorbent Assay; D005240:Feasibility Studies; D006801:Humans; D016014:Linear Models; D051381:Rats; D017207:Rats, Sprague-Dawley; D015203:Reproducibility of Results
chemical_list: D000906:Antibodies