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Analytical performance specifications: relating laboratory performance to quality required for intended clinical use
Daniel A Dalenberg1, Patricia G Schryver, George G Klee
1Department of Laboratory Medicine and Pathology, Mayo Clinic, 200 First Street Southwest, Rochester, MN 55905, USA.
Clinics in Laboratory Medicine
|January 22, 2013
Summary
This study sets analytic performance goals for key quality indicators like precision and detection limits, using clinical data to ensure reliable laboratory testing. These goals aid in evaluating the performance of 46 chemistry tests on the Roche cobas 8000 analyzer.
Area of Science:
- Clinical Chemistry
- Laboratory Medicine
- Analytical Performance Evaluation
Background:
- Establishing analytic performance goals is crucial for ensuring the reliability and clinical utility of laboratory test results.
- Current methods for defining performance goals often lack direct links to clinical practice and patient data.
- Standardized, data-driven goals are needed to assess laboratory test quality effectively.
Purpose of the Study:
- To propose analytic performance goals for five key quality indicators: precision, trueness, linearity, detection limits, and consistency.
- To define these goals using methods directly linked to clinical practice data and biological variation.
- To evaluate these quality indicators for 46 chemistry tests on a specific analyzer platform.
Main Methods:
- Goals for precision and trueness were based on biological variation.
- Linearity goals were established in relation to total error recommendations.
- Detection limit goals were derived from the 0.1 percentile of patient values, and consistency goals from patient test value distributions.
- Data for these quality indicators were collected and analyzed for 46 chemistry tests on the Roche cobas 8000 analyzer.
Main Results:
- Analytic performance goals were successfully defined for precision, trueness, linearity, detection limits, and consistency.
- The proposed methods provided a framework for setting clinically relevant performance targets.
- Evaluation data for 46 chemistry tests on the Roche cobas 8000 analyzer were generated based on these goals.
Conclusions:
- The proposed analytic performance goals, derived from clinical practice data, offer a robust method for quality assessment in laboratory medicine.
- These data-driven goals enhance the evaluation of test performance, ensuring greater reliability and clinical relevance.
- The study provides a benchmark for assessing the performance of chemistry tests on modern analytical platforms like the Roche cobas 8000.
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