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Immunofluorometric assay of pepsinogen C and preliminary clinical applications

¹ Department of Pathology and Laboratory Medicine, Mount Sinai Hospital, 600 University Ave., Toronto, ON M5G 1X5, Canada.

² Department of Clinical Biochemistry, University of Toronto, 100 College St., Toronto, ON M5G 1L5, Canada.

³ Servicio de Citometria, Universidad de Oviedo 33006, Oviedo, Spain.

⁴ Departamento de Bioquimica y Biologia Molecular, Facultad de Medicina, Universidad de Oviedo 33006, Oviedo, Spain.
^a Address correspondence to this author at: Depts. of Pathology and Clinical Biochemistry, Mount Sinai Hospital, 600 University Avenue, Toronto, ON M5G 1X5, Canada. Fax 416-586-8628; e-mail epd{at}eric.on.ca

We developed mouse monoclonal antibodies (Abs) against pepsinogen C with highly purified antigen isolated from gastric mucosa. The Abs were used to construct a two-site sandwich-type assay for pepsinogen C with time-resolved fluorometry as a detection technique. The assay has a detection limit of 0.1 µg/L and is precise (within-run and day-to-day CVs <11%). We used this assay to measure pepsinogen C in seminal plasma, breast cyst fluid, amniotic fluid, male and female serum, serum from patients with prostate cancer, urine, breast tumor cytosolic extracts, breast milk, and cerebrospinal fluid. Highest pepsinogen C concentrations were in seminal plasma, followed by breast cyst fluid and amniotic fluid. We found no correlation between prostate-specific antigen concentrations and concentrations of pepsinogen C in serum of prostate cancer patients, and concluded that this marker is not useful for either diagnosing or monitoring prostatic carcinoma. The availability of a highly sensitive, reliable, and convenient method for quantifying pepsinogen C will allow investigations into the possible diagnostic value of this analyte in various clinical conditions, including benign breast diseases, breast cancer, fertility, and pregnancy.

Key Words: indexing terms: proteases • breast cancer • amniotic fluid • prognostic markers • androgen-regulated genes

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