Review Book

United States participated. Three levels of contamination were evaluated; a non- inoculated control level (0 CFU/test portion) , a low contamination level (~0.7 CFU/test portion) and a high contamination level (~2 CFU/test portion). Data were analyzed using the Probability of Detection (POD) statistical model as presented in the AOAC validation guidelines. Results : The dLPOD C values with 95% confidence interval for the GENE-UP Salmonella method with either alternative or traditional confirmation were: 0.00 (-0.03, 0.03), -0.02 (-0.15, 0.12) and 0.02 (-0.03, 0.09) for the non-inoculated, low and high contamination levels respectively. Conclusion : The dLPOD C results demonstrate no difference in performance between the candidate method and reference method for the matrix evaluated. Highlights: The GENE-UP Salmonella method, with ASAP and CHROMID Salmonella , provides industry with a simplified, rapid and accurate workflow for the detection of Salmonella in a broad range of foods and select environmental surfaces. _________________________________________________________________________ Introduction Salmonella, one of the leading causes of foodborne illness, has been a known causative agent of outbreaks for over 100 years. In the United States, it is estimated that each year more than 1 million people fall ill to the bacterium, with approximately 20,000 hospitalizations and nearly 400 deaths (1). The Centers for Disease Control and Prevention (CDC, Atlanta, GA) notes that Salmonella continues to have one of the two highest incidence of infections per 100,000 people (2). The impact from these illnesses has resulted in an estimated $3 billion cost to our healthcare system (3). The persistence of this organisms in our food chain underscores the need for reliable and accurate methods of detection. The GENE-UP ® Salmonella (SLM) utilizes a unique PCR technology that employs a dual

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