SPDS 09052014

SMPR Key Points:  Screening Method

Minimum  Acceptable   Results

Parameter  Requirements

Target Test  Concentration

Parameter

low  concentration

≥ 0.85 §

Use Appendix N:  ISPAM Guidelines for  Validation of  Qualitative Binary  Chemistry Methods.

LPOD

10 x  low conc.

≥ 0.95 §

Laboratory Validation

LPOD  (0)

0 ppm

≤ 0.05 §

Multi ‐

§ 95% confidence interval

SMPR Key Points:  Screening Method

Selectivity Study:

Minimum  Acceptable  R lt esu s

Final Test Conc.

Parameter

Parameter Requirements

Test each target compound listed in  Annex II at the final test  concentration. Test each non‐target panel  compound at the final 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  concentrat ion

100%  positive  results **

Target

≥95%

10 x  low  conc.

oratory Validation Non‐target

negative  results

Single Lab

**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.