of cases. The identification should be done using technique-specific, generally acceptable
48
criteria, such as those given in the European Commission Decision 2002/657/EC.
49
50
Interference Control
51
A control designed to confirm that a test matrix does not interfere with the assay's ability to
52
detect target compounds.
53
54
Probability of Identification (POI)
55
The proportion of positive analytical outcomes for an identification method for a given matrix
56
at a given analyte level or concentration.
57
58
PDE5 Inhibitors
59
For the purposes of this SMPR: PDE5 inhibitors are defined as avanafil, lodenafil carbonate,
60
mirodenafil, sildenafill, tadalafil, udenafil, or vardenafil; or any of their analogs. Refer to
61
the
Supplemental List of Known PDE5 Inhibitors
(as of July 2014) at the AOAC website
62
(address and hyperlink to be inserted).
63
64
4.
Method Performance Requirements
:
65
66
Study
Parameter
Parameter Requirements
Target Test
Concentration
Minimum
Acceptable Results
Single Laboratory Validation
Matrix
Study
POI @
low concentration
Minimum of 33 replicates
representing all target
compounds in Annex II and all
matrix types listed in Annex III,
spiked at or below the
designated low level target test
concentration.
100 ppm
90% POI
†
of the pooled data
for all target
compounds and
matrices.
POI @
high
concentration
Minimum of 5 replicates per
matrix type spiked at 10x the
designated low level target test
concentration.
10 x low conc.
100% correct
analyses are
expected
(1)
POI @
zero
concentration
Minimum of 5 replicates per
matrix type.
0 ppm
Multi- Laboratory
Validation
Matrix
Study
(2)
LPOI
Use Appendix N: ISPAM
Guidelines for Validation of
Qualitative Binary Chemistry
Methods.
Low
concentration
≥ 0.85
†
10 x low conc.
≥ 0.95
†
LPOI
(0)
0 pm
≤ 0.05
†
Notes:
†
95% confidence interval
(1)
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.
(2)
Multi-Laboratory Validation Matrix Study (LPOI and LPOI
(0
)
)
are not required for First Action
Official Methods of
Analysis
approval.
