American Metabolic Testing Laboratories are using the modified IRMA method, and Bioluminescent method that tests for all molecular species of the HCG hormone. Unfortunately, however, there is NO TEST for the ALPHA subunit of HCG, at this point in time. This may be the reason for a negative test result in an established cancer patient.
HCG is the pregnancy hormone, and according to Dr. Schandl, the "malignancy hormone". Two different, super-sensitive tests are used, where one will confirm the other. No other laboratory performs these tests at the sensitivity level that we do. Therefore, do-it yourself pregnancy tests, commercial lab reports, and the Navarro test do not accurately report normals below 5.0mIU/mL. Most cancer patients have HCG levels between 1 - 5. Our cut-off point is less than 1.0 and the sensitivity of our immunoradiometric assay (IRMA) is 0.03 mIU/mL!
Normal levels are <1.0, i.e. less than 1.0 for the super-sensitive IRMA test, and less than 1.1 for the second Bioluminescent test (HCG IMM). The gray zone for both HCG test methods, IRMA & IMM is 1.0 - 3.0.
It is a rather broad-spectrum tumor marker that can be elevated in all malignancies regardless of site. This hormone can be present in men and women in developing cancers several years prior to diagnosis. American Metabolic Testing Laboratories are using an ultra-sensitive, in-house modified method for HCG determination. Our technology utilizes radioimmunoassay or RIA. Self-test pregnancy kits, nor regular clinical laboratory methods can equal the sensitivity developed by Dr. Schandl.
Traditionally, the test is used for detection of pregnancy, ectopic pregnancy, threatened abortions, and miscarriages. It is also useful in patients with gestational trophoblastic disease, and evaluating and monitoring patients with testicular tumors and molar pregnancy.
HCG levels are extremely useful in following those germ cell neoplasms which produce HCG, particularly trophoblastic neoplasms. Following evacuation of a trophoblastic lesion, HCG should fall to normal in 6-8 weeks and stay there. Oral contraceptive use may delay this fall. Any other delay in the fall, or subsequent rise, is an indication for other further evaluation.
In germ cell neoplasms in the male, HCG and alpha fetoprotein are both useful tumor markers. They can be demonstrated histochemically in tissue to confirm diagnosis, and can be followed in serum to evaluate recurrence.
Values obtained with different assay methods should not be used interchangeably.