Matrix Additions Part 3: Matrix Extension Study Design and Execution

Webinar Description

The Food Safety Modernization Act (FSMA) has ignited a rapid evolution in the food industry, creating a need for food manufacturers to further scrutinize the methods which are being used to test their products. Demonstrating the effectiveness of rapid methods, such as an immunoassay, PCR, or LAMP, perform appropriately for the detection of pathogens in a food matrix is a critical step in safeguarding product safety. However, the performance of certified and/or validated qualitive microbiology methods is limited to the food matrices which were included in the accrediting validation study (s). Therefore, food producers, test kit suppliers, and third-party laboratories need to execute additional verification or validation studies to ensure that the method is fit-for-purpose for the end user’s specific needs. Matrix Additions: Part 3 will outline the process for evaluating a detection method on a new matrix in alignment with the validation parameters outlined in AOAC Appendix J microbiology method validation guidelines. The presentation will provide valuable insights regarding best practices in study execution and elucidate of the nuances in the matrix extension study design.

Learning Objectives:

1. Learn how to prepare microorganisms for inoculation and equilibrate inoculated food matrices prior to study execution.

2. Evaluate the inoculum level post-equilibration using Most Probable Number (MPN) determination.

3. Understand qualitative study design including the differences between paired vs. unpaired studies and confirmation steps.

4. Execute data interpretation using Probability of Detection (dPOD) statistical analysis.

Presenters

  • Patrick Bird, Panelist bioMerieux
  • Quynh-Nhi Le, Panelist Neogen
  • Amanda Brookhousr-Sisney, Moderator Midwest Laboratories