Methods for diagnosing benign prostatic diseases

Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving antigen-antibody binding – specific binding protein...

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435 794, 436 64, 436 86, G01N 33573

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active

061000493

ABSTRACT:
The present invention relates to novel methods for diagnosing benign prostatic diseases (BPD), such as benign prostatic hyperplasia, prostatitis, or glandular atrophy, in a male human patient without requiring a biopsy. The total prostate specific antigen (PSA) level in the blood or serum of the patient is measured. If the patient has a total PSA level of between about 2.5 ng/ml and 10.0 ng/ml, then the free PSA level in the blood or serum of the patient is measured. The proportion of free PSA to total PSA is calculated. If this proportion is equal to or greater than about 25%, then the patient is diagnosed as having BPD. Optionally, if the patient has a total PSA level of between 10.1 ng/ml and 20.0 ng/ml, then the free PSA level in the blood or serum of the patient can also be measured. The proportion of free PSA to total PSA is calculated. If this proportion is equal to or greater than about 25%, then the patient is diagnosed as having BPD.

REFERENCES:
patent: 5912135 (1999-06-01), Luderer et al.
Jacobsen, Steven J. et alia: "Comparability of the Tandem-R and IMx assays for the Measurement of Serum Prostate-Specific Antigen": vol. 44, No. 4: 512-518, 1994.
Leinonen, Jari et alia: "Double Label Time-Resolved Immunofluorometric Assay of Prostate-Specific Antigen and of its Complex with .beta..sub.1 -antichymotrypsin": Clin. Chem.; vol. 39, No. 10: 2098-2103, 1993.
Tillyer, Colin R. et alia: "Disagreement between the Roche Cobas Core and Hybritech TANDEM-E PSA assays when measuring free, complexed and total serum prostate specific antigen": Ann. Clin. Biochem.: 31:501-505, 1994.

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