ISPAM September 6 2014 Meeting - page 58

Pre-decisional draft, do not distribute
Baby Spinach
43
Spinach (
Spinacia oleracea
)
that has been harvested during a fairly early stage of plant growth,
44
usually between 15-35 days after planting.
45
46
dPOD (Differential Probability of Detection)
47
The POD for any two methods can be compared by difference at a given analyte concentration. This
48
difference in POD values is termed dPOD.
49
50
Exclusivity
51
Study involving pure non-target strains, which are potentially cross-reactive, that shall be not
52
detected or enumerated by the tested method
.
4
See Annex III for a list of recommended non-target
53
strains.
54
55
Fractional Positive:
56
Validation criterion that is satisfied when an unknown sample yields both positive and negative
57
responses within a set of replicate analyses. The proportion of positive responses should fall within
58
25% and 75% and should ideally approximate 50% of the total number of replicates in the set. A set
59
of replicate analyses are those replicates analyzed by one method (either alternative or reference).
60
Only one set of replicates per matrix is required to satisfy this criterion.
61
62
Inclusivity
63
Study involving pure target strains that shall be detected or enumerated by the alternative method.
5
64
See Annex II for a list of recommended target strains.
65
66
Laboratory Probability of Detection (LPOD)
67
The POD value obtained from combining all valid collaborator data sets for a method for a given
68
matrix at a given analyte level or concentration.
6
69
70
LCL
71
Lower confidence limit.
72
73
Pre-Harvest Field Sample
74
Prior to harvesting.
75
76
Probability of Detection (POD)
77
The proportion of positive analytical outcomes for a qualitative method for a given matrix at a given
78
analyte level or concentration.
79
80
Relative Level of Detection
81
The ratio of the Level of Detections (LOD) of an alternative method and the reference method
82
RLOD = LOD
alt
/ LOD
ref
.
8
83
84
4
Ibid.
5
Ibid.
6
Appendix H: Probability of Detection (POD) as a Statistical Model for the Validation of Qualitative Methods,
Official Methods of Analysis of AOAC INTERNATIONAL, 19
th
edition, 2012.
7
Ibid.
8
2
nd
Draft ISO/FDIS 16140-2
2
Draft
Salmonella
SMPR v12
1...,48,49,50,51,52,53,54,55,56,57 59,60,61,62-63,64-65,66-67,68-69,70-71,72,73,...114
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