200 / 1195
28
For the analysis of orange juice, collaborators will receive 72 test portions, 36 test portions to be
analyzed by the BAX® System Real-Time PCR Assay for
Salmonella
and 36 test portions to be analyzed by
the FDA/BAM reference method. Each set of 36 test portions will contain: 12 un-inoculated controls, 12
low level (target 0.2 – 2.0 cfu/test portion), and 12 high level (target 2 – 5 cfu/test portion). For the
analysis of hot dogs, collaborators will receive 36 test portions. The test portions will be analyzed using
the BAX® System Real-Time PCR Assay for
Salmonella
and the USDA/FSIS MLG reference method. See
flow diagrams 8.4 and 8.5. Test portions of each matrix will be inoculated with a different strain of
Salmonella
spp
.
, randomized and blind-coded for analysis. See Table 1 below for summary of the
evaluation.
Table 1. Overview of Study Design
Test Week
(Tentative
Date)
Matrix
Target
Salmonella
Levels
# Test
Portions
(per method)
Total Test
Portions/Week
Reference
Method
Week 1
(January
14, 2013)
Orange Juice
25g –BAX Real-
Time
25g – BAM
0 cfu/test portion
12
24
FDA/BAM
Chapter 5
0.2-2 cfu/test
portion
12
24
2-5 cfu/test
portion
12
24
Week 2
(January
22, 2013)
Hot Dogs
325g –BAX
Real-Time and
MLG
0 cfu/test portion
12
12
USDA/FSIS
MLG Ch. 4.05
0.2-2 cfu/test
portion
12
12
2-5 cfu/test
portion
12
12
•
Each laboratory will prepare and analyze all test portions. All test portions will be
randomized and blind-coded with a 3 digit reference number.
•
Collaborators will also receive one portion of each food matrix labeled “Temperature
Control”. Temperatures will be taken and recorded on the data sheet provided upon
receipt of samples. One additional 60 g APC control (negative) test portion will be
provided to each collaborator for each matrix to determine the total plate count on the
day of sample receipt (Friday) by the pour plate method.
Please note that the
Temperature Control and the APC Control are not test samples and will not be
artificially contaminated.
•
One matrix will be tested each week of the study. See below for shipping schedule.
•
Q Laboratories will prepare the test portions and ship them refrigerated via Federal
Express Overnight Priority to each collaborator.
The first set of sample test portions,
Collaborative Study Approved Protocol
Expert Review Panel Use Only