Partial Lysis Method for Cervical Screening

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Solution Overview

Problem

Current cervical screening methods require separate processes for cell morphology and molecular diagnostics, leading to potential cross-contamination and the need for double sampling, which can be inefficient and inaccurate.

Innovation Solution

A method of partial lysis that retains a sufficient number of intact cells for morphology observation while allowing for molecular component analysis, using mechanical shearing with beads or syringe shearing to create a sample mixture suitable for both cytology and genetic screening.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If complete lysis is performed to enable molecular component analysis, then molecular diagnostics capability is improved, but cell morphology integrity deteriorates

Engineering Contradiction:
Improvemolecular diagnostics capabilityVSAvoidcell morphology integrity
Core Design Contradiction:
Adaptability or versatilityVSShape

Solution Approach 1:

The patent applies partial lysis by controlling the duration and intensity of mechanical shearing (e.g., 30-60 seconds of bead beating) to achieve sufficient cell disruption for molecular component release while retaining enough intact cells for morphology assessment. This partial action resolves the contradiction by avoiding complete lysis that would destroy cellular structures.

Inventive Principle:
Principle #16Partial or excessive action

Solution Approach 2:

The patent modifies physical parameters such as shearing time, bead size, and mechanical force intensity to optimize the lysis degree. By adjusting these parameters, the method achieves a balance where molecular components are adequately released for detection while cellular morphology remains sufficiently intact for cytological evaluation.

Inventive Principle:
Principle #35Parameter changes

2Measurement precision

If separate sampling processes are used for morphology and molecular screening, then analysis accuracy is improved, but procedural complexity and time consumption worsen

Engineering Contradiction:
Improveanalysis accuracyVSAvoidprocedural complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent merges two separate diagnostic workflows (morphology screening and molecular screening) into a single integrated process. By performing partial lysis on a unified sample, the method enables both cytological evaluation of intact cells and molecular analysis of released components from the same specimen, eliminating the need for separate sampling procedures.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The patent creates a universal sample preparation method that serves multiple diagnostic functions simultaneously. The partially lysed sample can be used for both morphology assessment (requiring intact cells) and molecular diagnostics (requiring released nucleic acids or proteins), making the single sample versatile for different analytical purposes.

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Reliability

If double sampling is performed to avoid cross-contamination, then sample purity is improved, but loss of time and resources worsens

Engineering Contradiction:
Improvesample purityVSAvoidtime consumption
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent segments the sample into different functional components through partial lysis: intact cells remain available for morphology screening while lysed components provide molecular material for genetic testing. This segmentation within a single sample eliminates cross-contamination risks between separate samples while maintaining the purity needed for both diagnostic purposes.

Inventive Principle:
Principle #1Segmentation

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

This approach streamlines the diagnostic process by enabling simultaneous analysis of cell morphology and genetic markers from a single sample, reducing cross-contamination and maintaining the integrity of cellular structures for accurate results.

Implementation Method 1

The method comprises mechanically shearing cells in the sample by bead beating, i.e. shaking the sample together with a multitude of beads. The rapid motion of the beads shreds cells.

Methodology Applied
Scientific EffectMechanical shearing: Mechanical Force

Data Source

PatentUS11719607B2Method of partial lysis and assay
Publication Date: 2023.08.08 HOLOGIC INC
  • US11719607B2 patent drawing
  • US11719607B2 patent drawing
  • US11719607B2 patent drawing

AI summary

The present disclosure describes a method of treating a sample comprising cells with a process of partial lysing. Cells are exposed to a process such as bead beating that lyses some cells in the mixture. The process generates a resultant sample mixture that is suitable for both cell morphology screening and genetic screening.