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Table of Contents
1
2
1.0
Introduction
3
1.1
BAX® System Real-Time PCR Assay for
Salmonella
4
1.2
Summary of the
Performance Tested Method
/Pre-collaborative study
5
1.3
Study Director
6
2.0
Collaborators
7
3.0
Study Design
8
4.0
Sample Preparation and Distribution
9
4.1
Hot Dogs
10
4.2
Orange Juice
11
5.0
Analysis and Confirmation
12
6.0
Reporting Raw Data
13
7.0
Statistical Analysis
14
8.0
BAX® System Real-Time PCR Assay for
Salmonella –
Method
15
9.0
References
16
10.0
Appendices
17
10.1
BAX® System Real-Time PCR Assay for
Salmonella –
Pre-collaborative Study Results
18
10.2
Instructions to Collaborators
19
10.3
Data Report Forms
20
10.4
Collaborator Comment Form
21
10.5
Study Materials
22
10.6
Flow Diagrams
23
10.7
Collaborator Information Sheet
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
Collaborative Study Approved Protocol
Expert Review Panel Use Only