False-Positive hCG Assay Results Leading to Unnecessary Surgery and Chemotherapy and Needless Occurrences of Diabetes and Coma

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Abstract
Much concern has been raised by the unraveling at the hCG Reference Service of six cases of persistent phantom human chorionic gonadotropin (hCG). These are false-positive hCG results, which are likely attributable to human anti-mouse IgG or to heterophilic antibodies (1)(2)(3). The hCG Reference Service, started in January 1998 to aid with the interpretation of irregular or discordant hCG immunoassay results, requests parallel serum and urine samples. Each is tested in four separate two-step microtiter plate ELISAs (assay 1 detects intact hCG, assay 2 detects nonnicked or bioactive hCG only, assay 3 detects the hCG free β-subunit only, and assay 4 detects the hCG β-core fragment only) at three different concentrations (undiluted, a 1:2 dilution, and a 1:5 dilution). From the data, inferences are made about the nature (nonnicked or nicked hCG, free β-subunit, and β-core fragment) and likely source (trophoblast disease, pituitary hCG, cancer, or phantom hCG) of the hCG immunoreactivity.

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