title: Comparison of chemiluminescence enzyme immunoassay (CLEIA) with ELISA for the determination of anti-cyclic citrullinated peptide antibodies.
abstract: BACKGROUND
  Autoantibodies against cyclic citrullinated peptide (anti-CCP) are sensitive and highly specific markers for rheumatoid arthritis (RA). We evaluated the analytical and diagnostic accuracy of chemiluminescence enzyme immunoassay (CLEIA) for anti-CCP antibodies, and compared it with that of ELISA.
  
  
  METHODS
  Ninety-nine RA patients who were diagnosed according to the American College of Rheumatology criteria, 16 patients with osteoarthritis, and 94 healthy subjects were included. Sera were used to assess the precision, functional sensitivity, and linearity of anti-CCP antibody determination by CLEIA and the correlation of anti-CCP antibody values between CLEIA and ELISA.
  
  
  RESULTS
  For anti-CCP antibodies by CLEIA, the total CV was 4.0 and 5.3% at 21.17 and 90 U/ml, respectively, and the lower limit of detection was 0.1 U/ml. The correlation of CLEIA (x) with ELISA (y) for anti-CCP was: y=1.08x+4.171, r=0.9178 (p<0.0001). No difference was observed in the sensitivity and specificity between CLEIA and ELISA.
  
  
  CONCLUSIONS
  The automated CLEIA processing system for determining anti-CCP antibodies showed a good analytical performance, and suggested that the CLEIA system has a potential to provide clinically useful data within a short time.
authors.affiliation: The Department of Orthopedic Surgery, Gifu University Graduate School of Medicine, 1-1 Yanagido, Gifu City, Japan. l2111509@edu.gifu-u.ac.jp
authors.forename: Ryo
authors.initials: R
authors.lastname: Tanaka
authors.forename: Masao
authors.initials: M
authors.lastname: Takemura
authors.forename: Masao
authors.initials: M
authors.lastname: Sato
authors.forename: Yasunori
authors.initials: Y
authors.lastname: Yamada
authors.forename: Takahito
authors.initials: T
authors.lastname: Nakagawa
authors.forename: Takuro
authors.initials: T
authors.lastname: Horibe
authors.forename: Masato
authors.initials: M
authors.lastname: Hoshi
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Otaki
authors.forename: Hiroyasu
authors.initials: H
authors.lastname: Ito
authors.forename: Mitsuru
authors.initials: M
authors.lastname: Seishima
authors.forename: Katsuji
authors.initials: K
authors.lastname: Shimizu
mesh_terms: D000906:Antibodies / Q000276:immunology*; D001172:Arthritis, Rheumatoid / Q000175:diagnosis*; D002956:Citrulline / Q000737:chemistry*; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D006801:Humans; D007124:Immunoenzyme Techniques / Q000379:methods*; D049449:Luminescence; D010456:Peptides, Cyclic / Q000737:chemistry / Q000276:immunology*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D000906:Antibodies; D010456:Peptides, Cyclic; D002956:Citrulline