Assay Range Computation Using Historical Variability Data
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
The challenge lies in establishing statistically valid assay means and ranges for quality control materials, which is crucial for ensuring the proper functioning of automated medical testing machines, as existing methods require extensive testing across multiple machines and laboratories, leading to high costs and inefficiencies.
Innovation Solution
A method that computes a statistically valid assay mean and range by accessing historical test results from prior lots, estimating variability, and setting a target probability, allowing for a reduced number of new tests to establish assay ranges, thereby minimizing the need for extensive testing across different instruments and laboratories.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If extensive testing across multiple machines and laboratories is performed to establish assay means and ranges, then statistical validity is improved, but cost and time consumption increase significantly
Solution Approach 1:
The patent performs preliminary characterization of quality control materials during the manufacturing process, establishing baseline assay means and ranges before the materials are released. This preliminary action eliminates the need for extensive subsequent testing at customer sites, as the statistical parameters are already determined through controlled manufacturing testing. The system uses historical data from multiple lots to establish predictable ranges, reducing the burden on end-users.
Solution Approach 2:
The patent performs preliminary characterization of quality control materials during the manufacturing process, establishing baseline assay means and ranges before the materials are released. This preliminary action eliminates the need for extensive subsequent testing at customer sites, as the statistical parameters are already determined through controlled manufacturing testing. The system uses historical data from multiple lots to establish predictable ranges, reducing the burden on end-users.
2Reliability
If extensive testing across multiple machines and laboratories is performed to establish assay means and ranges, then statistical validity is improved, but cost increases significantly
Solution Approach 1:
The patent performs preliminary characterization of quality control materials during the manufacturing process, establishing baseline assay means and ranges before the materials are released. This preliminary action eliminates the need for extensive subsequent testing at customer sites, as the statistical parameters are already determined through controlled manufacturing testing. The system uses historical data from multiple lots to establish predictable ranges, reducing the burden on end-users.
Solution Approach 2:
The patent implements a system where the quality control material manufacturer performs the statistical characterization and validation work themselves during production, rather than requiring customer laboratories to perform these costly validation studies. The manufacturer generates and provides assay means and ranges with each lot, enabling customers to immediately use the materials without incurring additional validation costs.
3Adaptability or versatility
If a large number of quality control materials are maintained to qualify every kind of machine, then machine qualification coverage is improved, but complexity of maintaining the reserve increases
Solution Approach 1:
The patent develops quality control materials with universal applicability across multiple machine types and test methods. By establishing comprehensive assay means and ranges during manufacturing that account for variability across different instruments and laboratories, a single quality control material lot can serve multiple machine platforms. This multi-functionality reduces the total number of different quality control materials needed in the system.
Solution Approach 2:
The patent uses statistical parameter transformations to create adaptable quality control materials. By establishing assay means and ranges that incorporate historical variability data from multiple sources, the system creates flexible reference ranges that can accommodate different machine types and test conditions without requiring separate materials for each configuration.
Data Source
AI summary
A method of establishing statistically valid assay means and ranges for quality control materials, used to qualify medical testing machines, utilizes tests on a new lot of quality control material to establish an assay mean, and uses data from a database of historical test results to establish an assay range. The system may estimate the variability of test results from prior lot data, and then compute the limits of the assay range such that a new test on a new lot of the quality control material will be expected to fall within the range with a specified probability. Because historical data is used to estimate the test variability, the number of new tests required to specify a statistically valid mean and range may be dramatically reduced, as compared with establishing the mean and range based only on tests of the new lot of material.