We are receiving a lot of questions about relevant analyses in the Analyse-it Method Validation edition to help in evaluating new diagnostic tests in the fight against COVID-19. Below are some quick links that will help, but contact us if you have questions - we are working as normal.

CLSI EP12-A2 for diagnostic accuracy see Sensitivity/Specificity, Predictive values, Estimating the sensitivity and specificity of a binary test and Comparing the accuracy of two binary diagnostic test.
CLSI EP17-A2 for detection capability of molecular methods using Probit analysis, see: Estimating the detection limit using a Probit fit and may be useful for determining the cutoff of a method with an internal continuous response see: Estimating the detection limit of a measurement system and Estimating the detection limit of a measurement system using a precision profile.

Also see our latest blog post: Sensitivity/Specificity and The Importance of Predictive Values for a COVID-19 test

EP12-A2 Example: Sensitivity specificity of 2 diagnostic tests

EP17-A2 Example 1:
LoB and LoD

EP17-A2 Example 2:
LoD from precision profile

EP17-A2 Example 4:
Probit detection limit

Revising control limits

After changes in a process it is necessary to revise the control limits.

On the Analyse-it ribbon tab, in the Report group, click Goto dataset.
On the worksheet, alongside the Phase column, click the drop-down arrow, then select the OQ check box, and click OK.
The data is filtered to the IQ and OQ phases.
On the Analyse-it ribbon tab, click Return to analysis.
On the Analyse-it ribbon tab, in the Process Control group, click Phases.
In the analysis task pane, the By drop-down list is displayed.
In the By drop-down list, select Phase.
On the Control Chart panel, select the Show process parameters check box.
Click Recalculate.

New control limits are computed for the new phase of the process. You can see the limits are much narrower and no-special cause variation is present.

Xbar-R control chart with process phases

Next topic: Monitoring future production