title: Clinical evaluation of a novel chemiluminescent immunoassay for the detection of anti-citrullinated peptide antibodies.
abstract: BACKGROUND
  We evaluated the analytical and clinical performances of a novel, automated chemiluminescent immunoassay in comparison with several anti-citrullinated protein antibody (ACPA) assays (2nd and 3rd generations) based on various platforms and technologies.
  
  
  METHODS
  Samples from rheumatoid arthritis (RA) patients (n=141) and controls (n=153) were collected based on an ordered ACPA test. All samples were tested with QUANTA Flash® CCP3, QUANTA Lite® CCP3, QUANTA Lite® CCP3.1, CCPlus and EliA® CCP assays. Rheumatoid factor (RF) was determined using Quantex RF(II). An additional cohort consisting of RA patients from three different sources (116, 79 and 50 samples), 61 juvenile idiopathic arthritis (JIA) patients and 233 controls were used in an extended evaluation on QUANTA Flash® CCP3 only. Precision and linearity of the QUANTA Flash® CCP3 were assessed according to CLSI guidelines.
  
  
  RESULTS
  All ACPA assays showed good qualitative and quantitative agreements. The Quanta Flash CCP3 assay showed good analytical and clinical performance. Based on the extended cohort, the sensitivity, specificity and likelihood ratios of the novel Quanta Flash® CCP3 were defined as 70.2%, 97.4% and 27.3/0.31, respectively.
  
  
  CONCLUSIONS
  Good agreements between different ACPA assays based on diverse platforms were found. Quanta Flash CCP3 is a reliable test for the fully automated and rapid detection of ACPA.
authors.affiliation: INOVA Diagnostics, Inc., San Diego, CA, United States.
authors.forename: Tyler
authors.initials: T
authors.lastname: Webb
authors.affiliation: INOVA Diagnostics, Inc., San Diego, CA, United States.
authors.forename: Gabriella
authors.initials: G
authors.lastname: Lakos
authors.affiliation: Center for Rheumatic Diseases, Neuss, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Swart
authors.affiliation: Center for Rheumatic Diseases, Neuss, Germany.
authors.forename: Irmgard
authors.initials: I
authors.lastname: Gürtler
authors.affiliation: Division of Rheumatologoy, Istituto G. Pini, Milano, Italy.
authors.forename: Ennio Giulio
authors.initials: EG
authors.lastname: Favalli
authors.affiliation: Division of Rheumatologoy, Istituto G. Pini, Milano, Italy.
authors.forename: Tommaso
authors.initials: T
authors.lastname: Schioppo
authors.affiliation: Center for Rheumatic Diseases, Neuss, Germany. Electronic address: mmahler@inovadx.com.
authors.forename: Michael
authors.initials: M
authors.lastname: Mahler
mesh_terms: D000368:Aged; D001172:Arthritis, Rheumatoid / Q000097:blood* / Q000175:diagnosis; D001323:Autoantibodies / Q000097:blood*; D015415:Biomarkers / Q000097:blood; D015331:Cohort Studies; D005260:Female; D006801:Humans; D008163:Luminescent Measurements / Q000379:methods / Q000592:standards*; D008297:Male; D008875:Middle Aged; D010456:Peptides, Cyclic / Q000097:blood*
chemical_list: D001323:Autoantibodies; D015415:Biomarkers; D010456:Peptides, Cyclic; C487763:cyclic citrullinated peptide
keywords: Autoantibodies; CCP; Citrullinated cyclic peptide; RA; Rheumatoid arthritis