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

Ann Clin Biochem 2003;40:663-673
doi:10.1258/000456303770367270
© 2003 Association for Clinical Biochemistry

 

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Original Articles


Elvira M Davelaar,
Eltjo MJ Schutter,
Silvia von Mensdorff-Pouilly,
Gerard J van Kamp,
Rob A Verstraeten and
Peter Kenemans


Department of Obstetrics and Gynaecology, Vrije Universiteit Medical Center, 1081 HV Amsterdam, The Netherlands;
Department of Obstetrics and Gynaecology, Medisch Spectrum Twente, 7511 JX Enschede, The Netherlands;
Department of Obstetrics and Gynaecology, Vrije Universiteit Medical Center, 1081 HV Amsterdam, The Netherlands;
Department of Clinical Chemistry, Vrije Universiteit Medical Center, 1081 HV Amsterdam, The Netherlands;
Department of Obstetrics and Gynaecology, Vrije Universiteit Medical Center, 1081 HV Amsterdam, The Netherlands;
Department of Obstetrics and Gynaecology, Vrije Universiteit Medical Center, 1081 HV Amsterdam, The Netherlands


Background: In this study the clinical and technical performanceof the CA125- detecting Bayer ACS:OV immunoluminometric serumassay was compared with three other well-established CA125-detectingassays.

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® CA125II assays.

Results: The clinical performance of the Bayer ACS:OV assay,assessed in various patient groups, was similar to that of thetwo other automated assays. In serum from patients with benigndiseases the highest values were found in patients with benignovarian tumours. In the ovarian cancer patients followed duringthe course of disease we found similar marker patterns withall four assays. In contrast to the Roche Enzymun-CA125 II assayand to a lesser extent the Centocor CA125 II assay, the BayerACS:OV assay was less sensitive to interference from HAMA.

Conclusion: The Bayer ACS:OV assay is a precise and reliabletest for the quantification of CA125 in serum.


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