title: False elevation of serum CA-125 level caused by human anti-mouse antibodies.
abstract: 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.
authors.affiliation: Department of Pathology, University of Florida Health Science Center/Jacksonville and Shands Hospital, Jacksonville, Florida 32209, USA. roger.bertholf@jax.ufl.edu
authors.forename: Roger L
authors.initials: RL
authors.lastname: Bertholf
authors.forename: Laura
authors.initials: L
authors.lastname: Johannsen
authors.forename: Benrubi
authors.initials: B
authors.lastname: Guy
mesh_terms: D000818:Animals; D000906:Antibodies / Q000097:blood*; D016477:Artifacts; D018394:CA-125 Antigen / Q000097:blood*; D005189:False Positive Reactions; D005260:Female; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D051379:Mice / Q000276:immunology*; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000097:blood; D010051:Ovarian Neoplasms / Q000097:blood
chemical_list: D000906:Antibodies; D018394:CA-125 Antigen