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.
Also see our latest blog post: Sensitivity/Specificity and The Importance of Predictive Values for a COVID-19 test
Transfer a reference limit or reference interval from one method or laboratory to another.
The tasks change to the analysis options for that partition.
The default null hypothesis is that the proportion of observations in the reference interval is equal to the reference level (95% default) against the alternative hypothesis that there are more or fewer observations in the interval. CLSI EP28-A3 performs a one-sided hypothesis test that proportion inside the interval is greater than or equal to 95% against the alternative that less than 95% are inside the interval.
You need at least 20 samples for a one-sided hypothesis test at the 5% significance level. More samples are required to be able to detect a significant difference for the two-sided hypothesis test, or when a smaller significance level is required.