Validation of an enzyme immunoassay for human choriogonadotropin as a tumor marker test

✍ Scribed by Bailey A. Birdsong; Herbert A. Fritsche; Frank J. Liu

• Publisher: John Wiley and Sons
• Year: 1987
• Tongue: English
• Weight: 304 KB
• Volume: 1
• Category: Article
• ISSN: 0887-8013
• DOI: 10.1002/jcla.1860010115

✦ Synopsis

We have evaluated a commercially available enzyme immunoassay for the determination of human choriogonadotropin (HCG) in human serum. The polyclonal antiserum to the p subunit of HCG was found to have less than 1.0% cross-reaction with lutropin (LH). The sensitivity of the assay was 1 .O mlU/ml, and the precision of the method, as measured by the coefficient of variation, was 3.8% at 57 = 12.8 mlu/ml and 5.4% at 57 = 66.3 mlulrnl. The upper limit of normal for the method, based on the 95th percentile, was as follows: men: 4 . 0 mlU/ml; premenopausal women: <1.7 mlU/ml; postmenopausal women: <3.9 mlU/ml. A method comparison study of 132 patient samples (radioimmunoassay vs enzyme immunoassay) gave a correlation coefficient of 0.959, with a slope of 0.963 and a y intercept of -0.683. A total of 422 enzyme immunoassays were performed on serial serum specimens collected from 42 patients with various clinical conditions associated with serum HCG abnormality. Excellent correlation was observed between the serial HCG pattern and the clinical course of the patients. The clinical correlations demonstrated the accuracy of the enzyme immunoassay for HCG and validate its use as a tumor marker test.