SMPR Key Points: Screening Method
Parameter
Parameter
Requirements
Target Test
Concentration
Minimum
Acceptable
Results
Laboratory Validation
LPOD
Use Appendix N:
ISPAM Guidelines for
Validation of
Qualitative Binary
Chemistry Methods.
low
concentration
≥ 0.85
§
10 x low conc.
≥ 0.95
§
Multi ‐
LPOD
(0)
0 ppm
≤ 0.05
§
§
95% confidence interval
SMPR Key Points: Screening Method
Parameter
Parameter Requirements
Final
Test Conc.
Minimum
Acceptable
R lt
Selectivity Study:
esu s
oratory Validation
Target
Test each target compound listed in
Annex II at the final test
concentration.
Low
concentrat
ion
100%
positive
results
**
Test each non‐target panel
compound at the final test
concentration or at the highest
expected matrix concentration in
≥95%
Single Lab
Non‐target
the case of naturally occurring
matrix components. A list of
potential non‐target compounds
for immunoassays is provided in
Annex III.
10 x low
conc.
negative
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.
