Prostate Cancer Diagnosis Using Combined PSA and Urinary AAT Markers
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Solution Overview
Problem
Current methods for determining prostate cancer, such as the PSA test and α1-antitrypsin level in urine, suffer from low specificity, leading to many false positives.
Innovation Solution
A method that combines the determination of prostate-specific antigen (PSA) levels in serum with α1-antitrypsin (AAT) levels in urine, standardized with creatinine, to achieve high sensitivity and specificity for prostate cancer diagnosis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If PSA test is used for prostate cancer determination, then sensitivity is high, but specificity is low leading to many false positives
Solution Approach 1:
The patent combines PSA level determination in serum with AAT level determination in urine into a single diagnostic method. By requiring both markers to be elevated simultaneously for a positive diagnosis, the method maintains the high sensitivity of PSA testing while dramatically improving specificity through the additional urinary AAT marker, thereby resolving the contradiction between sensitivity and specificity.
2Reliability
If α1-antitrypsin level in urine is used for cancer determination, then sensitivity is high, but specificity is low leading to many false positives
Solution Approach 1:
The patent integrates urinary AAT level determination with PSA level determination in a combined diagnostic approach. While urinary AAT alone provides high sensitivity, its low specificity is compensated by requiring concurrent elevation of PSA levels, thus maintaining sensitivity while improving specificity through the dual-marker requirement.
3Measurement precision
If combined determination of PSA level in serum and AAT level in urine is performed, then specificity is improved, but device complexity increases
Solution Approach 1:
The patent divides the diagnostic process into two separate but complementary examinations: one for measuring PSA levels in serum and another for measuring AAT levels in urine. This segmentation allows each test to be performed using standard, well-established methodologies, thereby improving specificity through combination while minimizing the increase in overall examination complexity by relying on routine testing procedures.
Data Source
AI summary
There is provide a method for determining whether a subject has developed or is suspected to have developed prostate cancer is provided, the method including: comparing a prostate-specific antigen (PSA) level in serum with a first threshold value; comparing an α1-antitrypsin (AAT) level in urine with a second threshold value; and determining whether a subject in which the PSA level in serum is the first threshold value or more and the AAT level in urine is the second threshold value or more has developed or is suspected to have developed prostate cancer.