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Annals of Clinical & Laboratory Science 32:414-418 (2002)
© 2002 Association of Clinical Scientists

False Elevation of Serum CA-125 Level Caused by Human Anti-Mouse Antibodies

Roger L. Bertholf1, Laura Johannsen2 and Guy Benrubi3
1 Department of Pathology, 2 Clinical Laboratories, and 3 Department of Obstetrics and Gynecology, University of Florida Health Science Center/Jacksonville and Shands Hospital, Jacksonville, Florida

Address correspondence to Roger L. Bertholf, Ph.D., Department of Pathology, University of Florida Health Science Center/Jacksonville, 655 West 8th St, Jacksonville, FL 32209, USA; tel 904 2445076; fax 904 244 4290; e-mail roger.bertholf{at}jax.ufl.edu.

Discordant results were observed for serum CA-125 (carbohydrate antigen-125) assays in a patient who was monitored for recurrence of ovarian cancer. Serum CA-125 levels in this patient were normal when measured in one laboratory, but >5-times the upper limit of normal (35 U/mL) when measured in another laboratory. Both laboratories used dual antibody heterogeneous immunoassays, but from different manufacturers. Cross-linking heterophilic antibodies were suspected as a cause of the discrepancy, but the interference was not alleviated after 10-fold dilution. Assay of the patient’s serum for human anti-mouse antibodies was positive, but only slightly above the reference range. Addition of blocking antibodies eliminated the interference, showing that human anti-mouse antibodies were the cause of the discrepant CA-125 results. These findings indicate that relatively low concentrations of human anti-mouse antibodies can cause significant interference in two-site immunoassays.

Keywords: ovarian cancer, carbohydrate antigen-125, immunoassay interference




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