METHOD VALIDATION
DATA ANALYSIS TOOL KIT

Please note: These tools use "pop-ups" to display the results of your entered data. If you have a browser that blocks pop-up windows, you may not be able to see any graphs. Also, we recommend using Netscape Navigator or Opera browsers. Internet Explorer browsers, particularly earlier than version 6, may not correctly display the graphs.

· Linear-data plotter can be used with data from a linearity experiment to assess the reportable range of a method. It provides a plot of the average of a group of replicate test results on the y-axis versus the assigned value (in % or concentration units) on the x-axis.

· SD Calculator can be with data from a replication experiment to calculate the mean, standard deviation (SD or smeas), and coefficient of variation (CV). A histogram display of the data is also available.

· Paired-data Calculator can be used with data from a comparison of methods experiment to calculate linear regression statistics (slope, y-intercept, and standard deviation about the regression line, sy/x), and the correlation coefficient (r, Pearson product moment correlation coefficient); t-test statistics (average difference between two methods or biasmeas; SDdiff, standard deviation of the differences between the two methods). It can also be used to provide a "comparison plot" that shows the test method results on the y-axis versus the comparative method results on the x-axis, as well as a "difference plot" that displays the difference between the test minus comparative results on the y-axis versus the comparative method result on the x-axis.

· Method Decision Calculator can be used to display the imprecision (%CV) and inaccuracy (%bias) of a method on a "method decision chart" to assess whether the performance of a method is excellent, good, marginal, or poor. The results from the SD Calculator and the Pair-data Calculator provide the estimates of method imprecision and inaccuracy, which are compared to the allowable imprecision and allowable inaccuracy as calculated from a defined analytical quality requirement, such as the CLIA proficiency testing criteria for acceptability.


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Westgard QC, 7614 Gray Fox Trail, Madison, WI 53717
Call 608-833-4718 or e-mail westgard@westgard.com

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