Primer-Flanked DNA Controls for qPCR Contamination Tracking

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Solution Overview

Problem

Quantitative polymerase chain reaction (qPCR) lacks effective spike-in controls to detect sample contamination and swapping during sample processing, which can lead to incorrect diagnoses in clinical applications.

Innovation Solution

The use of barcoded DNA molecules, optionally encapsulated in simulated cell membranes, flanked by primer binding sites, to be amplified during qPCR, allowing detection of cross-contamination and sample swapping through unique barcode signals.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional qPCR methods are used without spike-in controls, then the analysis is simpler and faster, but sample cross-contamination and swapping cannot be detected

Engineering Contradiction:
Improvedetection of sample cross-contamination and swappingVSAvoidcomplexity of qPCR control composition
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The control composition is segmented into multiple functional components: barcode sequences for sample identification, primer binding sites for amplification, and optional encapsulation structures. This segmentation allows each component to perform its specific function while maintaining overall system reliability for detecting sample contamination and swapping.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Barcoded spike-in control nucleic acids serve as intermediary elements between the sample and the qPCR detection system. These controls act as mediators that can be tracked through all processing steps, enabling detection of cross-contamination and swapping without interfering with the actual sample analysis.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If barcoded spike-in controls are added to monitor sample integrity, then sample cross-contamination and swapping can be detected, but the qPCR process becomes more complex

Engineering Contradiction:
Improvesample integrity monitoringVSAvoidqPCR control composition structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The barcoded spike-in controls serve multiple functions simultaneously: they act as internal controls for sample tracking, provide GC content variation for efficiency control, and can be encapsulated in different structures to control for lysis efficiency. This multi-functionality reduces the need for separate control systems.

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

Solution Approach 2:

The control composition utilizes parameter changes in barcode sequences and GC content to differentiate between samples and control for various qPCR conditions. By varying these parameters, the system can monitor multiple aspects of sample integrity using a unified control approach.

Inventive Principle:
Principle #35Parameter changes

3Measurement precision

If multiple control compositions with different GC contents are used, then GC content bias can be controlled, but the manufacturing and handling becomes more difficult

Engineering Contradiction:
Improvecontrol for GC content biasVSAvoidmanufacturing of control compositions
Core Design Contradiction:
Measurement precisionVSEase of manufacture

Solution Approach 1:

The patent applies parameter changes by creating control compositions with systematically varied GC content (e.g., 40%, 50%, 60% GC). This standardized parameter variation allows for control of GC content bias while maintaining ease of manufacture through systematic design of the nucleic acid sequences.

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

Enables effective monitoring of sample cross-contamination and swapping throughout the qPCR process, ensuring accurate results by differentiating between samples and controlling for GC content and lysis efficiency.

Implementation Method 1

The quantitative polymerase chain reaction (qPCR), which is also referred to as q-RT-PCR (i.e., quantitative real-time polymerase chain reaction)

Methodology Applied
Scientific EffectPolymerase chain reaction (PCR):

Data Source

PatentEP3894553B1Methods for a quantitative polymerase chain reaction
Publication Date: 2025.10.08 BATTELLE MEMORIAL INST
  • EP3894553B1 patent drawingFigure 1
  • EP3894553B1 patent drawingFigure 2A~2B
  • EP3894553B1 patent drawingFigure 2C

AI summary

The invention relates to control compositions for a quantitative polymerase chain reaction. More particularly, the invention relates to control compositions for a quantitative polymerase chain reaction having at least one barcode sequence fragment and at least a first and a second primer binding site fragment, and to methods of their use.