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Two-stage procedure for evaluating interassay carryover on random-access instruments
B Schlain1, H Frush, C Pennington
1Abbot Laboratories, Abbot Park, IL 60064, USA.
Clinical Chemistry
|May 1, 1996
Summary
A new two-stage statistical method detects interassay carryover biases on the Abbott AxSYM immunoanalyzer. This procedure efficiently identifies and quantifies carryover sources, minimizing sample sizes for accurate bias detection.
Area of Science:
- Clinical chemistry
- Immunoassay technology
- Statistical analysis in diagnostics
Background:
- Interassay carryover can introduce significant biases in immunoassay results.
- Accurate detection of carryover is crucial for reliable diagnostic testing.
- The Abbott AxSYM System is a widely used automated immunoanalyzer.
Purpose of the Study:
- To develop and illustrate a statistical procedure for detecting interassay carryover biases.
- To provide a method for testing and estimating all potential sources of carryover.
- To minimize sample sizes required for bias detection and quantification.
Main Methods:
- A two-stage statistical procedure utilizing Dunnett's multiple comparison procedures with a control.
- First stage: Detects and eliminates non-biasing or very large carryover sources.
- Second stage: Extensively retests cases with insufficient data from the first stage.
Main Results:
- The developed procedure effectively detects and estimates interassay carryover biases.
- The two-stage approach optimizes sample usage by prioritizing critical sources.
- Methodology illustrated using data from the Abbott AxSYM Free T4 assay.
Conclusions:
- The proposed statistical procedure offers an efficient approach to managing interassay carryover.
- This method enhances the reliability of results from the Abbott AxSYM System.
- The procedure facilitates accurate bias detection while minimizing resource requirements.