Division 4.3.3 Requirements for qualitative screening methods (methods that do not give numerical values)F1

The development of validation guidelines for binary test methods is currently subject of various standardization bodies (e.g. AOAC, ISO). Very recently AOAC has drafted a guideline on this matter. This document can be regarded as the current state of the art in its field. Therefore methods that give binary results (e.g. visual inspection of dip-stick tests) should be validated according to this guideline

http://www.aoac.org/imis15_prod/AOAC_Docs/ISPAM/Qual_Chem_Guideline_Final_Approved_031412.pdf