CEA Measurement Accuracy in Viscous Pancreatic Cyst Fluid

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Solution Overview

Problem

Current methods for measuring carcinoembryonic antigen (CEA) in pancreatic cyst fluid often face challenges due to low sample volume, high viscosity, and elevated CEA levels exceeding instrument capabilities, leading to inaccurate measurements.

Innovation Solution

Diluting the biological sample with a diluent, such as saline or Diluent Universal, at a ratio of 1:10 to 1:50, and applying a correction factor of 0.7 when amylase levels exceed 15,000 units to accurately measure CEA levels, thereby overcoming the limitations of low volume and high viscosity.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If the biological sample is diluted with a diluent, then the measurement accuracy of CEA is improved, but the sample volume required increases

Engineering Contradiction:

ImproveCEA measurement accuracyVSAvoidsample volume

Core Design Contradiction:

Measurement precisionVSQuantity of substance

Solution Approach 1:

The patent applies parameter changes by adjusting the dilution ratio based on amylase levels. When amylase exceeds 15,000 units, a specific dilution ratio (1:10 to 1:50) is used along with a correction factor of 0.7 to account for the dilution effect. This dynamic adjustment of dilution parameters resolves the contradiction by optimizing measurement accuracy while managing sample volume requirements.

Inventive Principle:

Principle #35Parameter changes

2Ease of operation

If the biological sample is diluted with a diluent, then the viscosity problem is reduced, but the measurement process complexity increases

Engineering Contradiction:

Improvemeasurement processVSAvoiddilution process

Core Design Contradiction:

Ease of operationVSDevice complexity

Solution Approach 1:

The patent implements preliminary action by measuring amylase levels before performing CEA measurement. This preliminary step allows the system to determine the appropriate dilution strategy in advance, reducing viscosity issues before they interfere with the main measurement process. The correction factor application is also a preliminary calculation that simplifies the overall measurement process.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The diluent acts as an intermediary substance that mediates between the high-viscosity biological sample and the measurement instrument. By introducing this intermediate medium, the patent reduces sample viscosity to acceptable levels while the correction factor serves as a mathematical intermediary to account for the dilution effect, maintaining measurement accuracy.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Reliability

If the CEA level in the biological sample exceeds the instrument capability, then the measurement range is extended, but the measurement accuracy may be compromised

Engineering Contradiction:

Improvemeasurement capabilityVSAvoidCEA level accuracy

Core Design Contradiction:

ReliabilityVSMeasurement precision

Solution Approach 1:

The patent applies partial action by using a correction factor (0.7) that partially compensates for the dilution effect rather than attempting to fully reverse it. This approach extends the measurement capability to handle high CEA levels that would otherwise exceed instrument range, while maintaining acceptable accuracy through the corrective calculation.

Inventive Principle:

Principle #16Partial or excessive action

Data Source

PatentUS10444239B2Methods for measuring carcinoembryonic antigen

Publication Date: 2019.10.15 INTERPACE DIAGNOSTICS CORPORATION

AI summary

Disclosed herein are methods of accurately measuring carcinoembryonic antigen in a biological sample and methods of identifying and treating a mucinous cyst in a subject.