ISPAM September 6 2014 Meeting

Pre-decisional draft, do not distribute

7. Maximum Time-To-Determination: Maximum time to complete an analysis starting 131 from the test portion preparation to presumptive determination must be ≤ 24 hours.

132 133 134 135 136

8. Method Performance Requirements

Table 1: Matrix Dependent Criteria

Parameter

Parameter Requirements

Target Test Concentration*

Minimum Acceptable Results 25 to 75% positive rate; and dPOD ≥ 0, LCL < 0, UCL > 0 **

SLV: Minimum of 20 replicates per food type, artificially inoculated as outlined in internationally accepted method validation guidelines. SLV: Minimum of 5 replicates per food type artificially inoculated as outlined in internationally accepted method validation guidelines at 10x the AMDL concentration. SLV: Minimum of 5 replicates per food type that have tested negative with the reference method in the validation study and have not been artificially inoculated.

Acceptable Minimum Detection Level (AMDL)

1 to 5 cfu / test portion

10 to 50 cfu / test portion

High concentration

100% correct analyses are expected per food type ‡

0 cfu / test portion

Zero concentration

1 – 10 cfu / test portion 10 to 50 cfu / test portion 0 cfu / Test portion

0.15 ≥ LPOD C

≥ 0.85

dLPOD † =

LPOD

Multi-laboratory study.

LPOD § ≥ 0.95 dLPOD † =

LPOD ‡‡ ≤ 0.05

LPOD (0)

Multi-laboratory study.

Single laboratory study Multi-laboratory study

Combined levels

Paired study ≤ 1.5 Unpaired study ≤ 2.5

RLOD

* Confirm the target test concentration on the initiation of the method evaluation using the three- 137 level Most Probable Number (MPN) procedure. See Annex IV for further guidance. 138 ** It is expected that the range between the lower and upper control limits should encompass 0, if 139 not, the results must be investigated and an explanation provided. 140 ‡ 100% correct analyses are expected. All aberrations are to be re-tested following internationally 141 recognized guidelines. Some aberrations may be acceptable if the aberrations are investigated, 142 and acceptable explanations can be determined and communicated to method users. 143 § A t the 5% lower confidence limit. See Annex V. 144 ‡‡ At the 95% upper confidence limit. See Annex V.

145 146 147

Draft Salmonella SMPR v12

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