Blood Matrix Reference Material for Liquid Biopsy Validation
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Solution Overview
Problem
Current methods for detecting tumors, such as clinical-chemical examinations and imaging procedures, often lead to late detection of malignant changes, and existing reference materials for liquid biopsies do not adequately reflect the properties of human or animal samples, leading to unreliable diagnostic results due to lack of standardization and potential contamination.
Innovation Solution
The use of blood or blood components, such as plasma or serum, as a reference material in diagnostics, potentially with added stabilizers like formaldehyde or EDTA, to simulate patient blood samples and improve diagnostic quality, reliability, and objectivity, particularly in nucleic acid sequencing methods.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing reference materials (plasmid DNA, synthetic oligonucleotides) are used for liquid biopsy validation, then the validation process can be performed, but the reference materials do not adequately reflect the actual properties of human or animal blood samples, leading to unreliable diagnostic results
Solution Approach 1:
The patent creates a copy of the actual blood sample matrix by extracting nucleic acids from human or animal blood and reconstituting them in a controlled manner. This copied matrix retains the complex composition and properties of real blood samples, including proteins, lipids, and other interfering substances, making it a faithful representative for validation purposes rather than using simplified artificial controls
Solution Approach 2:
The patent modifies the reference material by adjusting the concentration of nucleic acids to match expected clinical ranges and by controlling the composition of the blood matrix. This allows the reference material to reflect actual clinical conditions while maintaining reproducibility and stability for validation use
2Measurement precision
If blood samples are used as reference material to improve standardization, then measurement precision and reliability improve, but the complexity of preparing and validating the reference material increases
Solution Approach 1:
The patent performs preliminary extraction and characterization of blood matrix components before creating the final reference material. By pre-processing the blood samples to isolate and quantify key components, and by establishing standardized protocols for matrix preparation in advance, the complex validation process is simplified and made reproducible
Solution Approach 2:
The patent creates a universal blood matrix reference material that can be used across different laboratories, diagnostic platforms, and validation studies. This standardized matrix serves multiple functions including accuracy verification, precision assessment, and quality control, replacing the need for multiple different reference materials
3Ease of manufacture
If internal laboratory standards are used for validation, then the validation process is simpler, but contamination risks increase and standardization between laboratories decreases
Solution Approach 1:
The patent uses a standardized blood matrix reference material as an intermediary between individual laboratory standards and clinical samples. This intermediary provides a common reference point that mediates between different laboratory practices, enabling comparison and standardization while reducing the impact of individual laboratory contamination and variability
Data Source
AI summary
The present invention relates both to a new reference material based on a blood matrix for use in diagnostics or in-vitro diagnostics, in particular those using sequencing methods of nucleic acids, such as polymerase chain reaction (PCR) or next generation sequencing (NGS), and to a method for its production including validation, in particular a non-invasive liquid biopsy (liquid biopsies).