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Is your assay stable? Using process stability and capability to evaluate assay performance.

Robert L Schmidt1, Lauren N Pearson1

  • 1Department of Pathology and ARUP Laboratories, University of Utah, Salt Lake City, UT, United States.

Clinica Chimica Acta; International Journal of Clinical Chemistry
|December 17, 2018
PubMed
Summary
This summary is machine-generated.

Stability analysis offers key metrics for evaluating laboratory assay performance and identifying areas for process improvement. This method helps prioritize which assays require enhancement for better precision and capability.

Keywords:
CapabilityProcess ImprovementQuality ControlStabilityStatistical Process Control

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Area of Science:

  • Clinical Chemistry
  • Laboratory Medicine
  • Process Improvement

Background:

  • Laboratories strive to enhance assay precision and process capability.
  • Metrics are needed to evaluate performance, identify improvement potential, and prioritize projects.
  • Stability analysis measures freedom from extrinsic variation; capability analysis assesses meeting external requirements.

Purpose of the Study:

  • To demonstrate how stability analysis provides metrics for evaluating assay performance.
  • To show how stability analysis indicates potential for assay improvement.
  • To illustrate the combined use of stability and capability analyses for prioritizing assay improvement.

Main Methods:

  • Employed the SR test and analysis of variance (ANOVA).
  • Compared short-term and long-term stability for two distinct laboratory assays.
  • Provided detailed calculations for illustrative purposes.

Main Results:

  • One assay, thyroid stimulating hormone (TSH), demonstrated stability.
  • The second assay, methotrexate, exhibited instability.
  • Stability analysis yielded quantifiable metrics for performance evaluation.

Conclusions:

  • Stability analysis is a valuable tool for assessing laboratory assay performance.
  • The metrics derived from stability analysis can guide process improvement initiatives.
  • Prioritization of assay improvement efforts can be effectively achieved using stability and capability analyses.