hygiena AOAC-RI Validation BAX System SalQuant Instructions

June 4, 2024
Hygiena

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hygiena AOAC-RI Validation BAX System SalQuant

hygiena AOAC-RI Validation BAX System SalQuant

INTRODUCTION

Process control and final product decisions based only on prevalence have shown limitations in reducing consumer risk. Therefore, adoption of validated quantification methodologies with low error and wide enumerable ranges should be utilized to make data-driven food safety decisions.

PURPOSE

The aim of this certification study was to compare the performance of the candidate method, BAX® System Real-Time PCR Assay for Salmonella (KIT2006) utilizing the SalQuant™ methodology, to the USDA-FSIS MLG Most Probable Number (MPN) quantitative reference method.

REGISTERED TRADEMARKS / GLOBAL CERTIFICATIONS

BAX® System Real-Time PCR Assay for Salmonella AOAC-RI Performance Tested Methods℠ Certification Number 081201 MicroTally™ Manual Sample Device is a trademark of MicroTally.

METHODOLOGY

Twenty samples per matrix were divided into 4 inoculation levels with Salmonella ATCC strains at low: 0.0–1.0 Log CFU/g(mL), medium: 1.5–2.5 Log CFU/g(mL), high: 2.5–3.5 Log CFU/g(mL), or uninoculated as negative controls, then cold-stressed for 48-72 hours. After the stress period, sample processing followed the Hygiena Pathogen Quantification Procedures Manual with incubation at 42 ˚C for 6 or 8 hours for SalQuant with the reference method performed in parallel. Candidate results were compared to the reference results with statistical equivalence within 90% confidence intervals and mean difference of ± 0.50 Log10 CFU/g(mL) utilizing the AOAC-RI quantitative worksheet.

SIGNIFICANCE

This certification provides the poultry, beef, and pork industries with an accurate, reliable, and validated quantification tool to reduce product hold times, verify corrective actions, monitor process control, and promote faster data-driven diversion decisions which ultimately reduces consumer risk in animal protein products.

RESULTS

The BAX SalQuant candidate method was comparable to the USDA-FSIS MLG MPN reference method at all inoculation levels for poultry rinsates, ground beef, ground pork, beef trim, pork trim, and MicroTally for beef and pork trim.

hygiena AOAC-RI Validation BAX System SalQuant 2 hygiena AOAC-RI Validation BAX System SalQuant 3

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