文档介绍：CardioChek Lipid Panel Evaluation Protocol Page 1 1/25/2010 Polymer Technology Systems, Inc. CardioChek ? parison Study Evaluation Protocol Bias Study, Precision and Linear Regression For application parisons to the Reference Laboratory Standard CardioChek Lipid Panel Evaluation Protocol Page 2 1/25/2010 mended Evaluation Protocol – Bias plus Precision Scope This protocol provides direction parative study of the Cardiochek lipid panel toa reference laboratory. 1. Expected Results Bias Evaluation Study – Average Difference Using a side-by-side evaluation, which employs the same venous blood sample for both methods, the expectation is that the average deviation of CardioChek results will be within ± 10% of results from the reference lab result for cholesterol, ± 12% for HDL and ± 15% for triglycerides. This value gives a general expectation of the expected average deviation ofa population of studies, but does not predict any individual deviation. This type of evaluation is done using a regression model (see #2). 2. Bias Evaluation Study – Regression Model Linear regression is the accepted statistical approach to parative data and defining the relationship of one method to another. Ina regression model, the key performance measures are the slope of the regression equation line, the y-intercept (., that point at which the regression line crosses the y axis of the graph) and the