title: Development of a new ARCHITECT automated periostin immunoassay.
abstract: BACKGROUND
  Periostin is being investigated as a potential biomarker for T-helper-2 (Th2)-driven asthma or eosinophilic inflammation and may help to identify patients more likely to benefit from interleukin-13-targeted treatments. We report the development and analytic performance of the investigational use only ARCHITECT Periostin Immunoassay, a new automated assay developed to detect serum periostin concentrations.
  
  
  METHODS
  We assessed assay performance in terms of precision, sensitivity, linearity, interference from classical immunoassay interferents and representatives of common asthma medications, specimen handling, and isoform reactivity. The assay was also used to assess the biological variability of serum periostin concentrations in samples from healthy volunteers and from subjects with uncontrolled asthma (the intended use population).
  
  
  RESULTS
  The percentage CVs for 5-day total precision, assessed using two instruments, was <6% across 2 controls and one serum-based panel. Limit of quantitation was 4ng/mL (dilution adjusted concentration), suiting the needs for this application. Dilution analysis yielded linear results and no endogenous sample or drug interferences were observed. All known periostin isoforms expressed in the mature human lung were detected by the assay.
  
  
  CONCLUSIONS
  Our studies provide support that the ARCHITECT Periostin Immunoassay is a reliable and robust test for measuring serum periostin concentrations.
authors.affiliation: Diagnostics Division, Abbott Laboratories, 100 Abbott Park Road, Abbott Park, IL 60064, United States.
authors.forename: Nicolette M
authors.initials: NM
authors.lastname: Jeanblanc
authors.affiliation: Diagnostics Division, Abbott Laboratories, 100 Abbott Park Road, Abbott Park, IL 60064, United States.
authors.forename: Philip M
authors.initials: PM
authors.lastname: Hemken
authors.affiliation: Diagnostics Division, Abbott Laboratories, 100 Abbott Park Road, Abbott Park, IL 60064, United States.
authors.forename: Maria J
authors.initials: MJ
authors.lastname: Datwyler
authors.affiliation: Diagnostics Division, Abbott Laboratories, 100 Abbott Park Road, Abbott Park, IL 60064, United States.
authors.forename: Susan E
authors.initials: SE
authors.lastname: Brophy
authors.affiliation: Translational Sciences, MedImmune, One MedImmune Way, Gaithersburg, MD 20878, United States.
authors.forename: T Scott
authors.initials: TS
authors.lastname: Manetz
authors.affiliation: Clinical Pharmacology and DMPK, MedImmune, 319 N Bernardo Ave, Mountain View, CA 94043, United States.
authors.forename: Rozanne
authors.initials: R
authors.lastname: Lee
authors.affiliation: Clinical Pharmacology and DMPK, MedImmune, 319 N Bernardo Ave, Mountain View, CA 94043, United States.
authors.forename: Meina
authors.initials: M
authors.lastname: Liang
authors.affiliation: Antibody Discovery and Protein Engineering, MedImmune, One MedImmune Way, Gaithersburg, MD 20878, United States.
authors.forename: Partha S
authors.initials: PS
authors.lastname: Chowdhury
authors.affiliation: Antibody Discovery and Protein Engineering, MedImmune, One MedImmune Way, Gaithersburg, MD 20878, United States.
authors.forename: Reena
authors.initials: R
authors.lastname: Varkey
authors.affiliation: Translational Medicine, MedImmune, One MedImmune Way, Gaithersburg, MD 20878, United States.
authors.forename: Ethan P
authors.initials: EP
authors.lastname: Grant
authors.affiliation: Translational Medicine, MedImmune, One MedImmune Way, Gaithersburg, MD 20878, United States.
authors.forename: Katie
authors.initials: K
authors.lastname: Streicher
authors.affiliation: Translational Medicine, MedImmune, One MedImmune Way, Gaithersburg, MD 20878, United States.
authors.forename: Lydia
authors.initials: L
authors.lastname: Greenlees
authors.affiliation: Translational Medicine, MedImmune, One MedImmune Way, Gaithersburg, MD 20878, United States.
authors.forename: Koustubh
authors.initials: K
authors.lastname: Ranade
authors.affiliation: Diagnostics Division, Abbott Laboratories, 100 Abbott Park Road, Abbott Park, IL 60064, United States. Electronic address: gerard.davis@abbott.com.
authors.forename: Gerard J
authors.initials: GJ
authors.lastname: Davis
mesh_terms: D000293:Adolescent; D001249:Asthma / Q000097:blood; D001331:Automation; D015415:Biomarkers / Q000097:blood; D001774:Blood Chemical Analysis / Q000379:methods*; D001800:Blood Specimen Collection; D016022:Case-Control Studies; D015815:Cell Adhesion Molecules / Q000097:blood*; D005260:Female; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D057230:Limit of Detection; D016014:Linear Models; D008297:Male; D013696:Temperature
chemical_list: D015415:Biomarkers; D015815:Cell Adhesion Molecules; C512835:POSTN protein, human
keywords: Automated immunoassay; Biomarker; Periostin; Respiratory