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Incurred sample reanalysis: enhancing the Bland-Altman approach with tolerance intervals
Fred E Lytle1, Randall K Julian, Amy M Tabert
1Indigo BioSystems, 20 East 91st Street, Indianapolis, IN 46240, USA.
Bioanalysis
|November 19, 2010
Summary
This study highlights the importance of incurred sample reanalysis for method performance evaluation. It proposes using Bland-Altman plots with tolerance intervals to assess accuracy and determine sample size for bioanalytical methods.
Area of Science:
- Analytical Chemistry
- Bioanalytical Science
- Pharmacokinetics
Background:
- Incurred sample reanalysis (ISR) is crucial for validating bioanalytical methods.
- Assessing method performance and reliability requires robust statistical tools.
- Determining appropriate sample sizes for studies impacts data quality.
Purpose of the Study:
- To introduce a combined approach using Bland-Altman plots and tolerance intervals for ISR.
- To demonstrate the utility of this method for evaluating bioanalytical method performance.
- To provide guidance on using this approach for determining minimum sample size.
Main Methods:
- Visual evaluation of method performance using Bland-Altman plots.
- Application of tolerance intervals to assess data variability.
- Calculation of 66.7% tolerance factors and comparison of difference metrics.
- Analysis of an example dataset to illustrate the methodology.
Main Results:
- The combination of Bland-Altman plots and tolerance intervals offers a visual assessment of method performance.
- This approach can aid in determining the minimum sample size required for studies.
- Probability plots can be used to evaluate error distributions effectively.
Conclusions:
- The proposed method provides a valuable tool for incurred sample reanalysis.
- This approach enhances the evaluation of bioanalytical method accuracy and reliability.
- Further discussion and application of these techniques are encouraged in the scientific community.
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