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SMPR Key Points:  Screening Method

Final

Minimum 

Selectivity Study:

Parameter

Parameter Requirements

Test Conc. Acceptable 

Results

Target

Test each target compound listed in 

Low 

100% 

Validation

Annex II at the final test 

concentration.

concentrat

ion

positive 

results

**

Test each non‐target panel 

d h fi l

Laboratory 

Non‐target

compoun at t e na test 

concentration or at the highest 

expected matrix concentration in 

the case of naturally occurring 

10 x  low 

≥95% 

negative 

Single 

matrix components. A list of 

potential non‐target compounds 

for immunoassays is provided in 

Annex III

conc.

results

 .

**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.