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
A reference limit defines a value where a given proportion of reference values are less than or equal to. A reference interval defines the interval between a lower and upper reference limit that includes a given proportion of the reference values.
The process of defining a reference interval is that reference individuals compromise a reference population from which is selected a reference sample group on which are determined reference values on which is observed a reference distribution from which are calculated reference limits that define a reference interval.
A point estimate of a reference limit is a single value that is the best estimate of the true unknown parameter; a confidence interval is a range of values and indicates the uncertainty of the estimate. It is important to remember that the width of the confidence interval is dependent upon sample size and that large sample sizes are required to produce narrow confidence intervals, particularly for skewed distributions (Linnet, 2000).
There are numerous quantile estimators that may define the reference limits. The best estimator depends heavily on the shape of the distribution.