The Second Generation CA125 Assays

Abstract

Optimal management of ovarian cancer patients can only be provided using the CA 125 serum test for treatment monitoring, early prediction of outcome and early detection of recurrence. The newly introduced second generation CA 125 assays, the Centocor CA 125 II IRMA, the Boehringer Mannheim Enzymun CA 125 II and the BYK Liamat CA 125 II are one-step heterologous double-determinant solid phase assays that utilize the M11 as capture antibody and the original OC 125 as tracer. The CA 125 II assays will probably replace the original CA 125 assays within a short period of time. For comparison reasons the Abbott IMx CA 125 assay was also included in this study. Highly similar CA 125 distribution patterns were obtained with these new CA 125 II assays. Linear regression analysis in ovarian cancer patients showed the following: Centocor CA 125 II = 0.98×CA 125 IRMA+ 10.7 (r = 0.8717, P<0.0001), Sy|x = 89.9; Enzymun CA 125 II = 1.03×CA 125 IRMA + 9.0 (r=0.8988, P<0.0001), Sy|x = 81.8; BYK Liamat CA 125 II = 1.17×CA 125 IRMA + 0.6 (r = 0.8930, P<0.0001), Sy|x = 96.8. Our first technical and clinical evaluation of these three new CA 125 II assays shows their superior analytical performance, in addition to a high qualitative and quantitative correlation with the original CA 125 IRMA.