Urinary Cell Preservation via pH Buffering and Formaldehyde Release

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Solution Overview

Problem

Current flow cytometry analysis of urinary cells requires fresh urine samples within six hours, making it logistically challenging and expensive, and excludes smaller clinics and medical practices from sample submission.

Innovation Solution

A method involving the use of a buffer substance to maintain pH between 6 and 8 and a formaldehyde releasing compound in urine samples, allowing for the preservation of urinary cells for analysis by flow cytometry.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If fresh urine samples are used for flow cytometry analysis, then analysis accuracy is maintained, but logistical complexity and cost increase due to time constraints

Engineering Contradiction:
Improveanalysis accuracyVSAvoidlogistical complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The urine sample is treated with a formaldehyde releasing compound and buffer substance immediately after collection to preserve cellular morphology and markers before analysis. This preliminary preservation action allows the sample to be stored and transported without degradation, resolving the contradiction between maintaining analysis accuracy and reducing logistical complexity.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The chemical state of the urine sample is changed by adding a formaldehyde releasing compound that releases formaldehyde to fix cells, and a buffer substance that adjusts pH to neutral or slightly alkaline levels. These parameter changes stabilize the sample for long-term storage while maintaining cellular integrity for flow cytometry analysis.

Inventive Principle:
Principle #35Parameter changes

2Stability of the object's composition

If urine samples are preserved using formaldehyde, then cell stability is improved, but staining quality may be compromised

Engineering Contradiction:
Improvecell stabilityVSAvoidstaining quality
Core Design Contradiction:
Stability of the object's compositionVSManufacturing precision

Solution Approach 1:

A formaldehyde releasing compound is used as an intermediary that slowly releases formaldehyde to fix cells. This controlled release mechanism provides sufficient fixation for stability while avoiding excessive formaldehyde concentration that would compromise staining quality. The buffer substance also acts as an intermediary to control the chemical environment.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The pH of the urine sample is adjusted to neutral or slightly alkaline levels using a buffer substance, which optimizes the fixation process. This parameter change allows effective cell stabilization while maintaining antibody staining quality, as the buffered conditions prevent excessive cross-linking and preserve epitope accessibility.

Inventive Principle:
Principle #35Parameter changes

3Ease of manufacture

If pH is not adjusted in urine samples, then sample processing is simplified, but formaldehyde precipitation occurs

Engineering Contradiction:
Improvesample processing simplicityVSAvoidsample reliability
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The pH of the urine sample is adjusted to neutral or slightly alkaline levels using a buffer substance. This parameter change prevents formaldehyde precipitation by creating optimal conditions for formaldehyde release and cell fixation, while the buffering capacity maintains pH stability throughout the preservation process.

Inventive Principle:
Principle #35Parameter changes

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 method enables the stable preservation of urinary cells for more than 4 to 6 hours, allowing for delayed analysis without compromising staining quality, and facilitates the storage and transport of urine samples.

Implementation Method 1

contacting a urine sample obtained from a patient with a buffer substance suitable to create and/or maintain a pH value in the range of 6 to 8

Methodology Applied
Scientific EffectpH buffering:

Implementation Method 2

contacting a urine sample obtained from a patient with a formaldehyde releasing compound yielding a preserved urine sample

Methodology Applied
Scientific EffectFormaldehyde release:

Data Source

PatentUS12292436B2Method for preserving urinary cells
Publication Date: 2025.05.06 CHARITE UNIVS MEDIZIN BERLIN
  • US12292436B2 patent drawing
  • US12292436B2 patent drawing
  • US12292436B2 patent drawing

AI summary

The present invention relates to a method for preserving urinary cells, the method comprising the step of contacting a urine sample obtained from a patient with a buffer substance suitable to create and/or maintain a pH value in the range of 6 to 8, particularly approx. 7, within said urine sample, and a formaldehyde releasing compound.