ISPAM Working Group Chair Presentation Book

SMPR Key Points:  Screening Method

Selectivity Study:

Minimum 

Final

Parameter

Parameter Requirements

Test Conc. Acceptable  Results

Test each target compound listed in  Annex II at the final test  concentration. Test each non‐target panel  d h fi l compoun at t e na test  concentration or at the highest  expected matrix concentration in  the case of naturally occurring  matrix components. A list of  potential non‐target compounds  for immunoassays is provided in  Annex III

Low 

100% 

Target

concentrat ion

positive  results **

Validation

≥95%  negative 

10 x  low 

Non‐target

conc.

results

Laboratory 

Single 

 . **100% correct analyses are expected.  Some aberrations may be acceptable if the aberrations are investigated,  and acceptable explanations can be determined and communicated to method users.