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



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



Clinica Chimica Acta; International Journal of Clinical Chemistry 490: 28-33



Many laboratories are involved in efforts to increase precision and improve process capability. Metrics to evaluate performance, assess potential for improvement, and prioritize improvement projects would facilitate these efforts. We show how stability analysis can provide metrics to evaluate assay performance and indicate potential for improvement. We also show how stability analysis along with capability analysis can be used to prioritize assays for improvement. Stability reflects the degree to which a process is free of extrinsic sources of variation. Capability reflects the ability of a process to meet external requirements. We used the SR test and analysis of variance to compare the short-term and long-term stability of two assays. We illustrate the analysis with detailed calculations for two assays. One assay (thyroid stimulating hormone) was stable and the other, (methotrexate) was unstable. Stability analysis provides metrics that can be used evaluate assay performance and to prioritize process improvement efforts.

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Accession: 066010545

Download citation: RISBibTeXText

PMID: 30553861

DOI: 10.1016/j.cca.2018.12.015


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