Test system

Add a test on the square root of the coefficient of determination (|r|) to your assay. To pass the test, the |r| value of the regression fit of the standard curve has to be greater than or equal to the lower margin set in the test definition.

If the test fails, all samples of the assay document are invalidated.

Add a test on the upper asymptote to your assay. To pass the test, the value of the upper asymptote of the standard curve has to be greater than or equal to the lower margin set in the test definition. You can enter the margin manually or derive it from the highest dose of the Standard sample.

If the test fails, all samples of the assay document are invalidated.

Add a test on the slope to your assay. To pass the test, the value of the slope of the standard curve has to be greater than or equal to the lower margin set in the test definition and less than or equal to the upper margin.

If the test fails, all samples of the assay document are invalidated.

Add a test on the intercept to your assay. To pass the test, the value of the intercept of the standard curve has to be greater than or equal to the lower margin set in the test definition and less than or equal to the upper margin.

If the test fails, all samples of the assay document are invalidated.

Add a test on the B parameter to your assay. To pass the test, the value of the B parameter of the standard curve has to be greater than or equal to the lower margin set in the test definition and less than or equal to the upper margin.

If the test fails, all samples of the assay document are invalidated.

Add a test on the inflection point to your assay. To pass the test, the value of the inflection point of the standard curve has to be greater than or equal to the lower margin set in the test definition and less than or equal to the upper margin.

If the test fails, all samples of the assay document are invalidated.

Add a test on the lower asymptote to your assay. To pass the test, the value of the lower asymptote of the standard curve has to be lesser than or equal to the upper margin. You can enter the margin manually or derive it from the lowest dose of the Standard sample.

If the test fails, all samples of the assay document are invalidated.

Add a test on the recovery of the positive product control associated with Test samples to your assay. To pass the test, the recovery of the PPC has to be greater than or equal to the lower margin set in the test definition and less than or equal to the upper margin.

If the test fails, the respective Test sample is invalidated.

Add a test on the maximal percentual coefficient of variation (CV) on computed endotoxin concentrations for the observations of the Standard sample to your assay. The coefficient of variation is calculated for each dilution step individually. To pass the test, the coefficient of variation has to be lower than or equal to the upper margin set in the test definition for each dose step.

If the test fails, all samples of the assay document are invalidated.

Add a test on the maximal percentual coefficient of variation (CV) on computed endotoxin concentrations for observations of samples to your assay. The test is evaluated for each individual sample. The sample's PPC is ignored. To pass the test, the coefficient of variation has to be lower than or equal to the upper margin set in the test definition. The test also passes if the CV of the sample is calculated as N/A, irrespective of whether all computed endotoxin concentrations fall below the lowest limit of quantification or are deemed as N/A due to other reasons.

If the sample fails the test, it is invalidated.

Add a test on the maximal percentual coefficient of variation (CV) on computed endotoxin concentrations for observations of positive product control (PPC) to your assay. The test is evaluated for the PPC of each sample. To pass the test, the coefficient of variation has to be lower than or equal to the upper margin set in the test definition. If the CV of the PPC is calculated as N/A, the test fails.

If the positive product control fails the test, the respective sample is invalidated.

Add a tests on the relative development of the blank to your assay. The relative blank development is calculated as the quotient of mean delta relative fluorescence units (dRFU) and mean initial response. To pass the test, the blank development has to be greater than or equal to the lower margin set in the test definition and less than or equal to the upper margin.

If any of the Blank control elements fails the test, all samples of the assay are invalidated.

Add a test on the mean calculated concentration of Blank controls to your assay. To pass the test, the value of the calculated concentration has to be lesser than or equal to the upper margin. You can enter the margin manually or derive it from the lowest dose of the Standard sample.

If any of the Blank control elements fails the test, all samples of the assay are invalidated.

Add a test on the maximum number of missing standard responses to your assay. The number is based on the difference between the final response and the initial response of the standard sample, where 'response' is the dRFU or net dRFU of a single well of the Standard sample. A response is considered missing if any of the following conditions are met:

• The respective observation is flagged as technical outlier.
• The response of the respective observation is missing or invalid.

To pass the test, the number of missing standard responses has to be lower than or equal to the upper margin set in the test definition.

Apply a Rounding setting to have the test round values prior to evaluation.

Rounded values are compared to the full-precision margins, critical values, or p-values used in the test.

The following options are available:

• No rounding
• x decimal places (where x is an integer from 0 to 5)

Rounding examples for the '0 decimal places' option: