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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.