QC Design
Is the QC planning process appropriate for POC devices? You bet. See this example application that shows how to plan QC for a glucose device.
Recommendations on how to use the QC Validator program with the European biologic goals for imprecision and inaccuracy have been published, along with some example applications [1]. Two additional applications are illustrated here to facilitate comparisons between the European biologic goals, the CLIA analytical quality requirements for total error, and the clinical quality requirements for medically important changes.
A simple example planning QC for hemoglobin using OPSpecs charts.
A simple example planning QC for hemoglobin using OPSpecs charts.
A simple example planning QC for hemoglobin using OPSpecs charts.