Performance characteristics of seven automated CA125 assays

Author manuscript. Cancer antigen 125 (CA125) is a high molecular mass glycoprotien, which is used as tumor marker to monitor disease progression, response to therapy and in early detection of recurrence after treatment for ovarian cancer. The Access 2, ADVIA Centaur, ARCHITECT i2000, AxSYM, Elecsys 2010, IMMULITE 2000, and VITROS ECi assays for CA125 were evaluated for analytical sensitivity, dilution linearity, imprecision, correlation and reference intervals. The maximum average deviation from target recoveries for dilution linearity studies ranged from 3.7% for the ADVIA Centaur to 18.2% for the IMMULITE 2000. Imprecision studies yielded total CVs of 2.0-8.3% at CA125 concentrations of 35 kU/L and 114 kU/L. Method comparison studies revealed good agreement with VITROS ECi comparison method with slopes ranging between 0.88 to 1.19 and correlation coefficients of >0.95. All methods show acceptable performance characteristics and generally compare well.