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Functional sensitivity
Patien samples with low levels of A were assayed 10 times in multiple runs on the V system and the mean and SD calculated for each sample.
The mean was then plotted against the %CV, and the data fitted to an exponential curve.
the equation was used to determine the 10%CV A value and the CV at the 99th percentile for the assay.
In all 95 samples giving a total of 950 test results were run over 12 days and the results used for determining the funtional sensitivity.
Two different reagent lots and 2 different calibrator lots were used.