Clinical and technical evaluation of the ACS:OV serum assay and comparison with three other CA125-detecting assays

Background In this study the clinical and technical performance of the CA125-detecting Bayer ACS:OV immunoluminometric serum assay was compared with three other well-established CA125-detecting assays. Methods A total of 1112 serum samples was included in this evaluation: 462 from apparently healthy women, 153 from patients with benign ovarian disease, 163 from patients with malignant ovarian disease, 10 from patients with borderline ovarian malignancies and 78 samples from 12 ovarian cancer patients during monitoring of disease. Serum samples from women with malignant endometrial (n=68) and colon (n=32) diseases were also included. Moreover, serum samples from women with benign uterine disease and endometriosis (n=136) plus 10 serum samples from men (n=7) and women (n=3) with human anti-mouse antibodies (HAMA) after immunoscintigraphy were included. All samples were tested in duplicate with the Bayer ACS:OV, the Centocor CA125 II, the Abbott IMx CA125 and the Roche (formerly Boehringer Mannheim) Enzymun-Test(R) CA125 II assays. Results The clinical performance of the Bayer ACS:OV assay, assessed in various patient groups, was similar to that of the two other automated assays. In serum from patients with benign diseases the highest values were found in patients with benign ovarian tumours. In the ovarian cancer patients followed during the course of disease we found similar marker patterns with all four assays. In contrast to the Roche Enzymun-CA125 II assay and to a lesser extent the Centocor CA125 II assay, the Bayer ACS:OV assay was less sensitive to interference from HAMA. Conclusion The Bayer ACS:OV assay is a precise and reliable test for the quantification of CA125 in serum.