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Sample suitability criteria

 

Linear model

 
 
Most of the suitability criteria options have an associated section that controls what action is taken if a suitability criteria fails.
 
For information only
 Yes / No
If  selected, this criteria will be marked "For Information Only" in the report. This option enables users to set criteria that they wish to track or investigate, but are not to be regarded as part of the regulatory report.
Continue assay on failure
 Yes / No
If selected, the report analysis will continue to the next steps even  if a criteria fails.
Print RP on failure
Yes / No
If selected, and the "continue" option is also selected, the report will print a value for the RP despite criteria failure.
 
Sample Suitability
Test group
Test
Criteria
Default values
 
 
 
 
 
 
Goodness of fit
 
 
 
 
Goodness of fit (Linearity)
p-value for F test if more than one replicate.
p-value for t test for quadratic model if not.
Critical p value
Default p=0.01
 
Correlation coefficient (r^2)
Square of the Pearson correlation coefficient
Lower limit
 
 
 
 
 
 
 
Parameter values
 
 
 
 
Significance of slope (dose response)
p-value for slope (B) being significantly different from zero
Critical p-value.
Whether the slope should be positive or negative.
 
 
 
 
 
 
 
Parallelism tests  for a discussion on parallelism tests see: Parallelism in Practice
 
 
 
 
Ranges for combinations of parameters
Range for A difference
Upper and lower limits
 
 
 
Range for D difference
 
 
 
 
Range for Normalised A difference
 
 
 
 
Range for Normalised D difference
 
 
 
 
Range for B difference
 
 
 
 
Range for Slope ratio
 
 
 
 Equivalence tests for combinations of parameters
CI for Slope difference
(Delta Method or Fieller's)
Confidence level for CI.
CI Upper and lower limits
 
 
 
Slope ratio
 
 
 
 
Normalised slope difference
 
 
 
Significance tests
F test
Critical P value
Default p=0.05
 
 
Chi squared test
Critical P value
 
 
Precision
Ratio of Upper to lower confidence limits
Set limit