Artificial Control Tissue via Fragment Mixing
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Solution Overview
Problem
Current histomorphological analysis lacks standardized controls and reference standards for quantitative analysis, leading to inter-laboratory variance and inefficiencies in diagnosing tumors and providing targeted therapies, due to the lack of reliable biological standards.
Innovation Solution
An artificial control tissue is created by shredding and mixing tissue fragments from multiple samples, resulting in a reproducible and inexhaustible source for histomorphological analysis, with 50% or more of the fragments having a maximal diameter of 500 µm or less, ensuring low inter-batch variability and accessibility from surplus tissue samples.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If external controls based on peptide suspensions, cell lines, or histoids are used, then control availability is improved, but inter-laboratory variability and validation time increase
Solution Approach 1:
The patent combines multiple tissue samples (at least 25 different tissue samples) into a single artificial control tissue block, merging diverse biological materials into one standardized resource that can be uniformly distributed and validated across laboratories, thereby reducing inter-laboratory variability and validation time
Solution Approach 2:
The patent changes the physical parameters of control tissues by shredding them into small fragments (maximal diameter of 500 μm or less) and embedding them in paraffin blocks, transforming heterogeneous tissue samples into a standardized, reproducible artificial control tissue that maintains biological variability while ensuring consistent processing and analysis across different laboratories
2Ease of operation
If diagnostic tissue is used as external control, then control accessibility is improved, but control consistency and standardization deteriorate
Solution Approach 1:
The patent segments multiple different tissue samples into numerous small fragments (at least 25 different tissue samples shredded into fragments with maximal diameter of 500 μm or less), which are then uniformly distributed within the artificial control tissue block, ensuring that each section contains representative material from all source tissues and maintaining consistent composition across different sections and batches
Solution Approach 2:
The patent creates a composite artificial control tissue by embedding shredded fragments from multiple different tissue samples into a paraffin block, combining diverse biological materials with a standardized embedding medium to produce a consistent, reproducible control tissue that maintains biological variability while ensuring uniform processing characteristics
3Adaptability or versatility
If multiple different tissue samples are used for control, then biological variability is improved, but manufacturing complexity and time increase
Solution Approach 1:
The patent performs preliminary actions by collecting and shredding at least 25 different tissue samples before embedding, preparing all the biological material in advance and distributing it uniformly within the paraffin block during the embedding process, thereby capturing biological variability in one step while simplifying subsequent sectioning and analysis
Solution Approach 2:
The artificial control tissue block serves multiple functions simultaneously: it provides positive and negative controls, maintains biological variability, ensures consistent processing, and can be sectioned repeatedly to generate multiple control slides, thereby eliminating the need for separate control tissues and reducing overall manufacturing complexity
Data Source
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AI summary
The invention relates to a method for the manufacture of an artificial control tissue comprising the steps of (a) providing ten or more tissue samples; (b) shredding the tissue samples into tissue fragments; (c) mixing the tissue fragments; and (d) forming an artificial control tissue. Further, the invention also pertains inter alia to artificial control tissue manufactured according to the method and/or comprising fragments of 25 or more tissue samples.