Background: Statistical testing of assay linearity using replicate
measurements made on binary mixtures of samples provides no information about the
significance of any detected deviations from linearity, which may often be
desirable.
Method: Performance of additional statistical analysis of the assay
data.
Result: Objective measures for non-linearity and the minimum detectable
deviation from linearity of the assay are obtained.
Conclusion: A few additional calculations from the available data make
it possible to assess whether or not an assay method needs improvement to achieve
adequate performance within its intended application.
