Photometric Interference Determination in In-Vitro Diagnostic Assays
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Solution Overview
Problem
In-vitro diagnostic analyzers face challenges in efficiently determining interference levels in photometric assays, which can lead to biased results due to substances like hemoglobin, bilirubin, and lipids. Current quality checks are resource-intensive, reducing throughput and increasing costs.
Innovation Solution
A method and analyzer system that minimize resource usage by performing a preliminary interference check during the photometric assay, followed by a separate quantitative interference test only if the preliminary check exceeds a predetermined threshold.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a separate photometric measurement is performed for every sample to quantitatively determine interfering substances, then measurement precision is improved, but productivity deteriorates (throughput reduced up to 50%)
Solution Approach 1:
The patent performs a preliminary semi-quantitative determination of interfering substances during the main photometric assay measurement. This preliminary check allows the system to identify samples that require further investigation, avoiding the need for separate quality checks on all samples and thus maintaining high throughput while ensuring measurement precision for potentially affected samples.
Solution Approach 2:
Instead of performing complete quantitative interference tests on every sample, the patent applies a two-stage approach: first a partial semi-quantitative assessment during the assay, then a complete quantitative test only for samples exceeding a predetermined threshold. This partial action strategy reduces overall resource consumption while maintaining measurement precision where needed.
2Reliability
If a separate photometric measurement is performed for every sample to quantitatively determine interfering substances, then reliability is improved, but loss of time increases (delayed time to result)
Solution Approach 1:
The preliminary semi-quantitative determination is integrated into the main assay measurement process, allowing the system to identify samples requiring further interference testing without delaying the overall workflow. Only samples exceeding the threshold proceed to separate quantitative measurement, minimizing time loss while ensuring reliability for affected samples.
Solution Approach 2:
The patent applies complete quantitative interference testing only to samples that exceed a predetermined threshold in the preliminary semi-quantitative assessment. This partial application of the time-consuming quantitative test reduces overall time to result while maintaining assay result reliability for samples where interference is actually present.
3Measurement precision
If a separate photometric measurement is performed for every sample to quantitatively determine interfering substances, then measurement precision is improved, but use of energy and analytical resources increases
Solution Approach 1:
The system performs a preliminary semi-quantitative assessment using the same photometric measurement resources already allocated for the main assay. This preliminary check identifies samples requiring additional quantitative interference testing, thereby optimizing resource consumption by limiting separate measurements to only those samples where interference is suspected.
Solution Approach 2:
Instead of allocating full quantitative interference testing resources to every sample, the patent implements a two-stage approach where complete quantitative measurement is performed only on samples exceeding a predetermined threshold. This partial resource allocation significantly reduces overall energy and analytical resource consumption while maintaining measurement precision for samples where it is actually needed.
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 reduces analytical resource usage, minimizes time to result, and lowers costs without compromising assay quality, thereby alleviating the need for risky user decisions regarding sample quality checks.
Implementation Method 1
the concentrations of these interfering substances can be determined by measuring optical absorbance at different wavelengths
Implementation Method 2
subjecting the sample/reagent mixture to a photometric measurement in order to obtain a result of the in-vitro diagnostic assay
Data Source
AI summary
A method of determining a level of interference with a photometric in-vitro diagnostic assay and an in-vitro diagnostic analyzer for carrying out the method are described. An aliquot of a sample is treated with at least one reagent to obtain a sample/reagent mixture and subjecting the sample/reagent mixture to a photometric measurement in order to obtain a result of the in-vitro diagnostic assay, and during the same photometric measurement determining a preliminary level of interference by semi-quantitatively determining one or more interfering substances in the same sample/reaction mixture. A separate photometric measurement of another aliquot of the same sample either undiluted or diluted with a liquid other than a reagent is triggered in order to determine an effective level of interference by quantitatively determining the one or more interfering substances, only upon determining a preliminary level of interference above a predetermined threshold.