Methods of predicting estrogen-dependent osteopenia
AssigneeImmuna Care Corporation
InventorThomas L. Klug
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Abstract
Diagnostic/prognostic methods are provided for screening for pathologies wherein an alteration in estrogen metabolism is indicative of a pathology or a susceptibility thereto which comprise detecting and/or quantifying directly in tissues and body fluids of mammals abnormal levels of estrone metabolites and their glucuronide conjugates. Particularly preferred methods involve the use of the 16OHE1-glucuronide fraction, i.e., the fraction which contains 16.alpha.-hydroxyestrone (16OHE1) and its conjugates, 16OHE1-3-glucuronide. Methods of preparing reagents to detect said 16OHE1-glucuronide fraction in tissues and body fluids are disclosed as well as test kits for performing the disclosed assays.
Claims44
A method of screening for an osteopenic pathology affecting estrogen-sensitive tissues of a human wherein an altered level of a metabolite of estrone and its respective 3-glucuronide is indicative of the pathology, or a susceptibility thereto, in said human which comprises:
- A. obtaining a urine, serum or tissue sample from said human in which said pathology is suspected;
- B. detecting the level of a particular metabolite of estrone and its respective 3-glucuronide from said sample;
- C. comparing this said level with the level derived from the testing of healthy humans to detect differences therefrom of said particular metabolite of estrone and its respective 3-glucuronide.
A test kit for the screening of an osteopenic pathology wherein an altered level of a metabolite of estrone and its respective 3-glucuronide is indicative of the pathology or a susceptibility thereto, using the serum, tissue or body fluid medium of a human under test, comprising:
- (a) a predetermined amount of at least one detectably labeled immunochemically reactive estrone metabolite and its 3-glucoronide, or an antibody binding epitope thereof and;
- (b) directions for use of said kit.
Dependencies are inferred from the claim text.