How do you validate a qualitative test? Here's an introduction to a tiny little tool you might find useful for virus assay validation
Basic Method Validation
In this first lesson, Dr. Paulo Pereira introduces some of the basic concepts of method validation that apply when a qualitative method is being evaluated.
CLIA and CAP require continuous calibration verification. Interestingly, the regulations aren't that specific about how to judge whether or not the calibration is successful.
Bias, Accuracy, Inaccuracy, call it what you will. Sometimes your method generates different results than other methods, for example, systematically shifting values high or low. Laboratories must determine if bias exists in their methods, and estimate the severity of that bias.
It's not some new age religion, it's yet another confusing aspect of method validation. This time Dr. Westgard teams up with Trish Barry to explain the ins and outs. (Preview)