Biosensor Analytical Zone Wash Fluid for Reduced Sample Precision

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Solution Overview

Problem

Diagnostic testing with reduced sample volumes faces challenges in precision, accuracy, and consistency due to reagent carryover and the limited aqueous components in whole blood samples, leading to inaccurate analyte detection.

Innovation Solution

Introducing a fluid containing the target analyte into the analytical zone of a biosensor before the sample, which acts as a wash fluid to clear pre-existing fluids and enhance precision, particularly in assays with reduced sample volumes.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If reduced sample volumes are used, then sample volume is reduced, but measurement precision deteriorates due to reagent carryover and insufficient aqueous components

Engineering Contradiction:

Improvesample volumeVSAvoidanalyte detection precision

Core Design Contradiction:

Quantity of substanceVSMeasurement precision

Solution Approach 1:

The patent applies preliminary action by introducing a wash fluid containing the target analyte into the analytical zone before the actual sample analysis. This pre-rinsing step removes pre-existing reagents and fluids from the sensor surface, preventing carryover effects that would otherwise contaminate the reduced sample volume and compromise measurement precision.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The wash fluid serves as an intermediary substance between the previous measurement and the current reduced sample volume analysis. It mediates the transition by clearing residual reagents from the analytical zone while maintaining appropriate ionic strength and pH conditions, thereby enabling accurate measurements even with minimal sample volumes.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Quantity of substance

If reduced sample volumes are used, then sample volume is reduced, but measurement accuracy deteriorates due to carryover effects

Engineering Contradiction:

Improvesample volumeVSAvoidanalyte detection accuracy

Core Design Contradiction:

Quantity of substanceVSManufacturing precision

Solution Approach 1:

The patent converts the potentially harmful carryover effect into a beneficial calibration step by using a wash fluid containing the target analyte. The known concentration of analyte in the wash fluid allows the system to account for and correct any carryover effects during the measurement of the actual sample, thereby improving accuracy despite reduced sample volumes.

Inventive Principle:

Principle #22Blessing in disguise (Convert harm into benefit)

3Quantity of substance

If reduced sample volumes are used, then sample volume is reduced, but consistency deteriorates due to limited aqueous components

Engineering Contradiction:

Improvesample volumeVSAvoidmeasurement consistency

Core Design Contradiction:

Quantity of substanceVSStability of the object's composition

Solution Approach 1:

The patent changes the chemical parameters of the analytical zone by introducing a wash fluid with controlled ionic strength, pH, and composition. This creates a stable chemical environment that compensates for the limited aqueous components in reduced sample volumes, ensuring consistent and reproducible measurements across multiple analyses.

Inventive Principle:

Principle #35Parameter changes

Data Source

PatentUS10473638B2Methods and systems for improving precision of measurements for reduced sample volumes

Publication Date: 2019.11.12 SIEMENS HEALTHCARE DIAGNOSTICS INC

AI summary

There is described a process for improving precision in an analytical test for a target analyte in a sample. The process includes prior to analyzing the sample for a target analyte via a biosensor, introducing to an analytical zone defined by the biosensor a fluid comprising an effective amount of the target analyte.