Single-Sample Cholate Test for Portal Blood Flow Assessment
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Solution Overview
Problem
Current methods for monitoring hepatic function and portal blood flow in patients with liver disease, such as chronic hepatitis C, nonalcoholic fatty liver disease, and primary sclerosing cholangitis, are invasive, inaccurate, or impractical, lacking a simple and effective non-invasive screening test for early detection and monitoring of disease progression.
Innovation Solution
A non-invasive STAT test that estimates portal blood flow and hepatic function by orally administering isotopically labeled cholic acid and analyzing a single blood sample taken 60 minutes later, correlating the cholate concentration with established cutoff values to assess liver disease severity and progression.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If multiple blood samples are taken over 90 minutes (FLOW test) or simultaneous oral and intravenous doses are administered (SHUNT test), then measurement precision of portal blood flow is improved, but device complexity and ease of operation deteriorate
Solution Approach 1:
The patent extracts only the essential measurement element from the complex FLOW and SHUNT test procedures. By identifying that a single blood sample at a specific time point (60 minutes) after oral administration contains sufficient information to estimate portal blood flow, the invention removes the need for multiple blood draws and complex dual-route administration, thereby simplifying the procedure while maintaining clinical utility
Solution Approach 2:
The patent applies partial action by using only a single blood sample rather than the full multiple-sample protocol of the FLOW test. This partial sampling approach, combined with the specific 60-minute time point selection, provides sufficient data to estimate portal blood flow without requiring complete pharmacokinetic profiling, thus reducing procedural complexity while preserving measurement value
2Measurement precision
If multiple blood samples are taken over 90 minutes, then measurement precision is improved, but loss of time increases
Solution Approach 1:
The patent employs preliminary action by selecting and validating a specific time point (60 minutes) in advance where the cholate concentration provides optimal information about portal blood flow. This pre-determined timing eliminates the need for prolonged monitoring and multiple subsequent blood draws, reducing test duration from 90 minutes to a single time point while maintaining measurement precision
Solution Approach 2:
The invention extracts the critical measurement moment from the extended 90-minute monitoring period. By identifying that the 60-minute time point contains the essential information needed for accurate portal blood flow estimation, the patent removes the need for continued monitoring beyond this point, thereby significantly reducing the time investment required
3Measurement precision
If multiple blood samples are taken, then measurement precision is improved, but ease of operation deteriorates
Solution Approach 1:
The patent removes the burdensome aspects of the original protocol by extracting only the essential elements: oral administration of cholate and a single blood draw at 60 minutes. This eliminates the need for intravenous access, multiple blood draws, and complex coordination, making the test much easier to administer in routine clinical practice
Solution Approach 2:
The patent enables self-service by using oral administration of cholate, which patients can take themselves without requiring intravenous access or complex medical intervention. Combined with a single blood draw, this creates a patient-friendly protocol that is easy to administer and requires minimal clinical infrastructure
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The STAT test provides a reliable, single-point assessment of portal blood flow, enabling early detection and monitoring of chronic liver diseases, superior to existing methods in detecting early-stage conditions and tracking disease progression.
Implementation Method 1
Cholic acid is extracted from the portal circulation by the liver during a 'first pass'
Implementation Method 2
The labeled cholic acid compounds can be differentiated, for example, by their distinct mass spectra in mass spectrometry
Data Source
AI summary
A method for estimating portal blood flow and hepatic function in a subject is provided. In one example, the STAT test is an in vitro simplified, convenient test intended for screening purposes that can reasonably estimate the portal blood flow from a single blood sample taken 60 minutes after orally administered deuterated-cholate. The test can be administered to a patient having, or suspected of having, Chronic Hepatitis C, Primary Sclerosing Cholangitis (PSC), Non-Alcoholic Fatty Liver Disease (NAFLD), or any chronic liver disease.