Lateral Flow Test Receptacle for Controlled Fluid Volume

Solution Overview

Problem

Current lateral flow tests for peritonitis in peritoneal dialysis patients face challenges such as variable result times, high culture-negative rates, and issues with analyte volume application, leading to potential false positives and hazards due to oversaturation.

Innovation Solution

Devices and methods for lateral flow testing that include a first receptacle for receiving bodily fluids and a second receptacle with a predetermined volume for applying an appropriate amount to the test strip, featuring a transfer mechanism to ensure accurate and controlled application, preventing oversaturation and enabling efficient testing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If sufficient analyte is applied to the strip, then the test can detect target substance, but too much analyte causes false positives and oversaturation hazards

Engineering Contradiction:

Improvedetection accuracyVSAvoidfalse positives and hazards

Core Design Contradiction:

Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The device pre-measures and pre-applies a predetermined, optimal volume of analyte to the test strip using a controlled dispensing mechanism. This preliminary action ensures that the correct amount of analyte is applied without requiring manual measurement by the user, thereby preventing both insufficient analyte (which would fail to reach the control line) and excessive analyte (which would cause false positives or oversaturation hazards).

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The device automatically performs the analyte application step without requiring user intervention for measurement and dispensing. The predetermined volume is applied autonomously by the device's dispensing mechanism, eliminating the need for the user to manually control the amount of analyte applied, thus preventing false positives and oversaturation while ensuring adequate detection.

Inventive Principle:

Principle #25Self-service

2Quantity of substance

If too much analyte is applied, then the test strip becomes oversaturated, but this causes false positives and spills

Engineering Contradiction:

Improveanalyte volumeVSAvoidtest accuracy

Core Design Contradiction:

Quantity of substanceVSReliability

Solution Approach 1:

The device pre-measures and pre-applies a predetermined, optimal volume of analyte to the test strip using a controlled dispensing mechanism. This preliminary action ensures that the correct amount of analyte is applied without requiring manual measurement by the user, thereby preventing both insufficient analyte (which would fail to reach the control line) and excessive analyte (which would cause false positives or oversaturation hazards).

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The device incorporates a control mechanism that monitors or indicates when the predetermined volume of analyte has been applied. This feedback mechanism ensures that the user knows when the optimal amount has been dispensed, preventing both under-application (which would prevent the control line from appearing) and over-application (which would cause false positives or spills).

Inventive Principle:

Principle #23Feedback

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

These devices allow for precise and safe application of bodily fluids to lateral flow test strips, reducing false positives and hazards, while ensuring effective detection of target substances, thereby improving diagnostic efficiency and accuracy in peritonitis testing.

Implementation Method 1

allowing the analyte to wick across the test strip via capillary action

Methodology Applied

Scientific EffectCapillary action: Capillary Action

Data Source

PatentUS11567071B2Devices and methods for lateral flow tests of bodily fluids

Publication Date: 2023.01.31 FRESENIUS MEDICAL CARE HOLDINGS INC

AI summary

The disclosed devices for lateral flow testing may include a receptacle for receiving bodily fluids from a patient that has a predetermined fluid volume for application to one or more lateral flow test strips. A test strip holder may be positioned to receive the predetermined fluid volume of the bodily fluids from the receptacle. Various other components, devices, and methods are also disclosed.