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8
preenrichment broth (UPB) (35°C for 22-26 h) for the FDA BAM method. After primary
1
enrichment, ALL test portions (BAX and FDA BAM) will continue to selective enrichment. One
2
mL of each enriched portion will be transferred to 10 mL TT broth and 0.1mL will be transferred
3
to 10 mL RV broth.
Note: BAM Method RV medium must be made from individual ingredients
4
according to BAM formulation. Do not use commercial formulations.
RV tubes will be
5
incubated at 42 ± 0.2°C for 22-26 h using a circulating, thermostatically controlled water bath.
6
TT tubes will be incubated at 35 ± 2°C for 22-26 h. Secondary enrichments will be streaked to
7
bismuth sulfite (BS), xylose lysine desoxycholate (XLD), and Hektoen enteric (HE) agar plates and
8
incubated at 35°C for 22-26 h.
Isolated colonies will transferred to TSI and LIA slants and
9
incubated 35 ± 2°C for 22-26 h.
Salmonella
colonies will be confirmed using serological (Somatic
10
O and poly H agglutination) and biochemical procedures according to MLG Ch. 4.05.
11
12
6.0
Reporting Raw Data
13
14
Each level of each matrix will be analyzed and reported separately. Data may be excluded due to an
15
assignable cause, provided there is sufficient justification. Such data will not be included in the
16
statistical analysis. All data, even if excluded from the statistical analysis, will be reported (see
Appendix
17
X-B
of the AOAC Guidelines for raw data table format).
18
19
7.0
Statistical Analysis
20
21
The statistical analysis will be performed in accordance with the AOAC Guidelines (
Appendix X-F
) using
22
the Least Cost Formulations, Ltd., AOAC Binary Data Interlaboratory Study Workbook (7).
23
24
7.1
Estimate the repeatability standard deviation (s
r
) for qualitative methods.
25
7.2
Estimate the reproducibility (s
R
) by calculating the standard deviation of the laboratory
26
POD values (s
POD
) and associated 95% confidence intervals.
27
7.3
Estimate the difference of cross-laboratory POD (dLPOD) and associated 95% confidence
28
intervals. If the confidence interval of a dLPOD does not contain a zero, then the
29
difference is statistically significant.
30
7.3.1
dLPODc is the difference between the candidate and reference LPOD values.
31
7.3.2
dLPOD is the difference between the presumptive and confirmed LPOD values.
32
33
In addition, the data will be analyzed by the Relative Limit of Detection (RLOD), as described in the most
34
current version of ISO 16140 (8).
35
36
8.0
BAX® System Real-Time PCR Assay for
Salmonella –
Method
37
38
BAX® System Real-Time PCR Assay for
Salmonella
Method for Detection of
Salmonella
in Foods and
39
Selected Environmental Surfaces
40
41
Collaborative Study Approved Protocol
Expert Review Panel Use Only