Yes, you can validate the performance of a qualitative method. No, you won't run the same statistical studies you would with a quantitative method. The positive: you run fewer studies for qualitative tests. The negative: they are a bit harder to set up and interpret.
Basic Method Validation
An earlier post on this website discussed the use of probit analysis for determining the limit of detection (LoD) for Nucleic Acid Amplification Tests (NAAT).
Ampliando la lección anterior sobre el estudio de acuerdo clínico, el Dr. Westgard analiza el valor predictivo de una prueba de laboratorio.
Determining Limit of Detection can be a challenge. Here's Part One of a discussion on how to do it.
CDC is strongly recommending that laboratories check their positive results with confirmatory testing. Here's Why and Here's How.