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
Test if the value of the reference material is equal to the assigned value; that is the bias is zero.
It is possible for the bias from a study to be different to 0, but for the difference to be due to the random error in your study. The smaller your study, the larger the bias has to be to be declared statistically significant. Also, just because bias is statistically significant does not mean that it is of concern, it may still meet your allowable bias performance requirements.