An improved procedure for testing for assay linearity.
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.


METHODS
Performance of additional statistical analysis of the assay data.


RESULTS
Objective measures for non-linearity and the minimum detectable deviation from linearity of the assay are obtained.


CONCLUSIONS
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.
Ross
H A
HA
Department of Chemical Endocrinology & Department of Endocrinology, University Medical Centre Nijmegen, PO Box 9101, 6500 HB Nijmegen, The Netherlands. a.ross@ace.azn.nl
Sweep
C G J
CG
D001671:Biochemistry / Q000379:methods*; D002624:Chemistry, Clinical / Q000379:methods*; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D004563:Electrochemistry / Q000379:methods; D015233:Models, Statistical; D015203:Reproducibility of Results