Upper and lower limits can be set for the mean or geometric mean, or the sum, of:
a) All control samples
b) By groups if present e.g. high, low
Reference standard
Goodness of fit of the model, or ‘linearity’
a) A quadratic model can be fitted to the data and the significance of the quadratic term tested via a z test.
The level (critical p value) can be chosen by the user.
Default is 0.05.
Parameter values
a) Ranges for parameter values ARef , BRef can be set.
b) Equivalence limits for ARef , BRef can be set:
Ranges for the confidence intervals for ARef , BRef (no default setting).
The confidence level for the each interval can be chosen by the user (no default setting).
Statistical significance of the slope
BRef via a one-sample z test comparing the slope with zero.
The level (critical p value) can be chosen by the user
Default is 0.05.
The sign of the slope must be stated (positive or negative).
Combinations of parameter values
Range for the ED50 = - ARef /BRef can be set.
Equivalence limits for - ARef /BRef can be set:
Ranges for the confidence intervals for ARef , BRef (no default setting).
The confidence level for the each interval can be chosen by the user (no default setting).
Variability of data
The variability can be assessed using the log-likelihood; a higher value of the log-likelihood corresponds to less variability. A lower limit for the log-likelihood can be set. Note the log-likelihood is always negative.
Quality Control
Goodness of fit of the model, or ‘linearity’
a) A quadratic model can be fitted to the data and the significance of the quadratic term tested via a z test.
The level (critical p value) can be chosen by the user.
Default is 0.05.
Parameter values
Statistical significance of the slope
, BQC
a) via a one-sample z test comparing the slope with zero.
The level (critical p value) can be chosen by the user
Default is 0.05.
The sign of the slope must be stated (positive or negative).
Parallelism with reference standard
Ranges for combinations of QC and reference slope parameters can be chosen.
Difference between slopes:
Ratio of slopes:
Normalised slope difference:
Equivalence tests for combinations of QC and reference slope parameters.
Ranges for the confidence intervals (no default setting) for:
Difference between slopes:
Ratio of slopes:
Normalised slope difference:
The confidence level for the each interval can be chosen by the user (no default setting).
Significance tests for lack of parallelism can be used:
χ2 test comparing the model with separate slopes with the parallel model.
The level (critical p value) can be chosen by the user.
Default is 0.05.
Relative potency of the QC sample, and its confidence interval
(For calculation of these parameters, see 4.1.5 below)
Allowed range for RP
Equivalence test for RP
Range for the confidence interval for RP (no default setting).
The confidence level can be chosen by the user (no default setting).
Precision: The ratio of upper confidence limit to lower confidence limit
The confidence level can be chosen by the user (no default setting).
The upper limit for the precision is chosen by the user
