Microbiology Methods for ERP Review 3-2020

192

Table of Contents

1 2 3 4 5 6 7 8 9

1.0

Introduction

1.1 1.2 1.3

Solus One Salmonella

Summary of the Performance Tested Method SM Validation

Study Director

2.0 3.0 4.0 5.0 6.0 7.0 8.0 9.0

Collaborators Study Design

Test Material Preparation and Distribution

10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42

Analysis and Confirmation

Reporting Raw Data Statistical Analysis

Solus One Salmonella  ‐ Method

References Appendices

10.0

10.1 10.2 10.3 10.4 10.5 10.6

Instructions to Collaborators

Study Materials Flow Diagram

Collaborator Information Sheet Sample Receipt Confirmation Form

Collaborator Comment Form

11.0

Attachments

1 Solus One Salmonella 1 plate issue – Kit Insert, Issue number: 4.0, Date: 11/19, Product

code: SAL1 ‐ 0096

2 Solus One Salmonella 5 plate issue – Kit Insert, Issue number: 4.0, Date: 11/19, Product

code: SAL1 ‐ 0480

3 PTM Report – Evaluation of the Solus One Salmonella method for the Detection of Salmonella species in Select Food and Environmental Surfaces, AOAC Performance

Tested Method SM 101801

4 PTM Report – Method Modification to Extend the Matrix Claim of Solus One Salmonella method for the Detection of Salmonella species in Spices and Flavor blends, AOAC

Performance Tested Method SM 101801 Solus One Salmonella – Data Report Form

5

2