title: Technical evaluation of the Beckman Coulter OV-Monitor (CA 125 antigen) immunoassay.
abstract: BACKGROUND
  The CA 125 antigen is a large (200-1000 kDa) glycoprotein, present within normal and benign ovarian tissue. We evaluated the analytical performance of the newly available Beckman Coulter OV-Monitor (CA 125 antigen) immunoassay on the Beckman Coulter UniCel DxI 800 analyzer.
  
  
  METHODS
  The evaluation was performed according to NCCLS recommendations.
  
  
  RESULTS
  The lowest level of CA 125 antigen detectable was 0.374 U/mL. Serial dilution of two pooled CA 125 antigen-rich samples provided a linear response (p<0.0001). For total CV% the following results were obtained: pool sera, 11.7 U/mL (2.70%), 56.3 U/mL (2.41%), 108.43 U/mL (2.31%); and QC sera, 29.4 U/mL (2.57%), 101.1 U/mL (3.26%). Comparison of the OV-Monitor on the UniCel DxI 800 showed linear regression values of r=0.961 vs. the Bayer ADVIA Centaur system and r=0.981 vs. the Abbott AxSYM system.
  
  
  CONCLUSIONS
  Considering the limited number of serum samples analyzed, our data indicate that the Beckman Coulter OV-Monitor immunoassay has excellent analytical performance and shows satisfactory correlation with automated immunoassays on the Abbott AxSYM and Bayer ADVIA Centaur systems. It is easy to perform, accurate and suitable for measurements in routine clinical laboratories.
authors.affiliation: Institute of Clinical Chemistry and Pathobiochemistry, RWTH-University Hospital Aachen, Germany. eyagmur@ukaachen.de
authors.forename: Eray
authors.initials: E
authors.lastname: Yagmur
authors.forename: Reinhard
authors.initials: R
authors.lastname: Driesch
authors.forename: Axel M
authors.initials: AM
authors.lastname: Gressner
authors.forename: Paul
authors.initials: P
authors.lastname: Kiefer
mesh_terms: D015295:Antigens, Tumor-Associated, Carbohydrate / Q000032:analysis; D018394:CA-125 Antigen / Q000032:analysis; D006801:Humans; D007118:Immunoassay / Q000295:instrumentation* / Q000592:standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D015295:Antigens, Tumor-Associated, Carbohydrate; D018394:CA-125 Antigen