Urinalysis Interference Flagging for Morphology-Based False Results

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Solution Overview

Problem

Current urinalysis systems face interference issues due to morphologically similar analytes leading to false-positive or false-negative results, which are not effectively addressed by existing automated sediment analyzers without manual inspection or additional analyses.

Innovation Solution

An automated urinalysis system generates interfering flags based on detection results of morphologically similar analytes, comparing their concentrations to user-configurable thresholds, alerting users to potential interference and optionally blocking result reporting, with manual confirmation possible.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If automated sediment analyzers are used for urinalysis, then productivity is improved, but reliability deteriorates due to false-positive or false-negative results from morphologically similar analytes

Engineering Contradiction:
Improveautomated urinalysis throughputVSAvoidaccuracy of analyte detection
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The system performs preliminary detection of multiple analytes including morphologically similar ones (e.g., yeast, calcium oxalate crystals, red blood cells) before final result reporting. By proactively identifying the presence of interferents in the urine sample, the system can flag potential interference issues before they lead to incorrect diagnostic conclusions, thus maintaining both automated throughput and result reliability

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system implements a feedback mechanism where detection results of morphologically similar analytes are used to validate or challenge the primary analyte detection. When interferents are detected above threshold levels, the system generates interfering flags that alert users to potential false results, allowing for manual verification while maintaining automated processing for clear cases

Inventive Principle:
Principle #23Feedback

2Reliability

If manual inspection and supporting analyses are performed to detect interference, then reliability is improved, but loss of time increases

Engineering Contradiction:
Improvedetection of interfering conditionsVSAvoidtime for manual verification
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The system applies partial manual intervention only when necessary - specifically when interferents are detected above predetermined thresholds. For samples without interference flags, the automated results are reported directly without manual review. This selective approach ensures reliability when needed while minimizing time loss by avoiding routine manual inspection of all samples

Inventive Principle:
Principle #16Partial or excessive action

Solution Approach 2:

The automated analyzer performs self-verification by detecting multiple analyte types simultaneously and using this information to identify potential interference issues. The system generates interfering flags automatically based on its own detection data, reducing the need for external manual verification and supporting analyses

Inventive Principle:
Principle #25Self-service

3Productivity

If automated sediment analyzers report results directly without interference detection, then productivity is improved, but measurement precision deteriorates

Engineering Contradiction:
Improvespeed of result reportingVSAvoidaccuracy of analyte concentration measurement
Core Design Contradiction:
ProductivityVSMeasurement precision

Solution Approach 1:

The system performs preliminary detection of interferents and generates interfering flags before final result reporting. By proactively identifying potential interference conditions (such as presence of yeast, calcium oxalate crystals, or other morphologically similar analytes), the system can alert users to exercise caution in interpreting results, thereby maintaining both rapid reporting and measurement precision through informed judgment

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentEP4142943B1Interfering flag to reduce falses diagnosis due to interfering conditions in microscopic morphology based sediment urinalysis
Publication Date: 2025.09.03 SIEMENS HEALTHCARE DIAGNOSTICS INC

AI summary

Non-limiting embodiments of a system(s) of generating interfering flags to reduce false diagnosis due to interfering conditions present in urinalysis results, and method(s) related thereto.