Evaluation of the GENE-UP ® Listeria monocytogenes Method for the Detection of Listeria monocytogenes in a Variety of Foods and Select Environmental Surfaces: Collaborative Study, First Action 2019.11

2020 ◽  
Author(s):  
Ronald Johnson ◽  
John Mills ◽  
Jean-Louis Pittet ◽  
Olivier Mathia ◽  
Patrick Bird ◽  
...  
Keyword(s):  
Listeria Monocytogenes ◽  
Collaborative Study ◽  
Control Level ◽  
Reference Method ◽  
Probability Of Detection ◽  
Cottage Cheese ◽  
The European Union ◽  
Inoculum Level ◽  
Test Portion ◽  
Environmental Surfaces

Abstract Background The GENE-UP®Listeria monocytogenes 2 (LMO 2) assay (Performance Tested MethodSM 121804) uses real-time PCR technology and a proprietary detection platform, the GENE-UP® Thermocycler, to detect Listeria monocytogenes in a variety of foods and environmental surfaces. Objective The purpose of this validation was to evaluate the method’s interlaboratory performance and submit the result to AOAC INTERNATIONAL for adoption as First Action Official MethodSM for the detection of Listeria monocytogenes in a variety of foods and select environmental surfaces. Method The GENE-UP® method was evaluated in a multi-laboratory study as part of the AFNOR NF VALIDATION certification process using unpaired test portions for one food matrix, full-cream goat milk cottage cheese (8.4% fat). The candidate method was compared to the ISO 11290-1/Amd.1:2004 reference method. Sixteen participants from 15 laboratories throughout the European Union participated. Three levels of contamination were evaluated: a non-inoculated control level (0 CFU/test portion), a low inoculum level (∼2 CFU/test portion) and a high inoculum level (∼10 CFU/test portion). Data from the study were analyzed according to the Probability of Detection (POD) statistical model as presented in the AOAC validation guidelines. Results The dLPODC values with 95% confidence interval for each comparison were; -0.02 (-0.07, 0.03), -0.08 (-0.31, 0.16) and 0.00 (-0.03, 0.03) for the non-inoculated, low and high contamination levels respectively. Conclusion The dLPODC results demonstrate no difference in performance between the candidate method and reference method for the matrix evaluated. Highlights The GENE-UP LMO method demonstrated accuracy and precision in detecting and discerning L. monocytogenes from other Listeria species.

Evaluation of the GENE-UP ® Listeria spp. Method for the Detection of Listeria Species in a Variety of Foods and Select Environmental Surfaces: Collaborative Study, First Action 2019.10

2020 ◽  
Author(s):  
Ronald Johnson ◽  
John Mills ◽  
Jean-Louis Pittet ◽  
Olivier Mathia ◽  
Patrick Bird ◽  
...  
Keyword(s):  
Collaborative Study ◽  
Control Level ◽  
Reference Method ◽  
Probability Of Detection ◽  
Cottage Cheese ◽  
Contamination Level ◽  
Official Method ◽  
Test Portion ◽  
Listeria Species ◽  
Environmental Surfaces

Abstract Background The GENE-UP®Listeria spp. 2 (LIS 2) assay (Performance Tested MethodSM 121803) is a real-time PCR molecular detection method for the rapid detection of Listeria species (Listeria monocytogenes, L. innocua, L. ivanovii, L. seeligeri and L. welshimeri) in a variety of foods and environmental surfaces. Objective The purpose of this validation was to evaluate the method’s interlaboratory performance and submit the results to AOAC INTERNATIONAL for adoption as First Action Official MethodSM for the detection of Listeria species in a variety of foods and select environmental surfaces. Method The GENE-UP® method was evaluated in a multi-laboratory study as part of the AFNOR NF VALIDATION certification process using unpaired test portions for one food matrix, full-cream goat milk cottage cheese (8.4% fat). The candidate method was compared to the ISO 11290-1/Amd.1 reference method. Sixteen participants from 15 laboratories throughout the European Union participated. Three levels of contamination were evaluated: a non-inoculated control level (0 CFU/test portion), a low contamination level (∼2 CFU/test portion) and a high contamination level (∼10 CFU/test portion). Data from that study were analyzed according to the Probability of Detection (POD) statistical model. Results The dLPODC values with 95% confidence interval between the candidate and reference method results were; -0.02 (-0.07, 0.03), -0.08 (-0.31, 0.16) and 0.00 (-0.03, 0.03) for the non-inoculated, low and high contamination levels respectively. Conclusion The dLPODC results demonstrate no difference in performance between the candidate method and reference method for the matrix evaluated. Highlights Data from a singular collaborative study was used to achieve adoption as AOAC First Action Official Method for the detection of Listeria species in a variety of foods and select environmental surfaces.

scholarly journals Evaluation of the Solus One Salmonella Assay in Select Foods: Collaborative Study: First Action 2020.03

2020 ◽  
Vol 103 (6) ◽  
pp. 1568-1581
Author(s):  
Benjamin Bastin ◽  
M Joseph Benzinger ◽  
Erin S Crowley ◽  
James Agin ◽  
Raymond Wakefield
Keyword(s):  
United States ◽  
Statistical Analysis ◽  
Collaborative Study ◽  
Control Level ◽  
Reference Method ◽  
The United States ◽  
Probability Of Detection ◽  
Inoculum Level ◽  
Test Portion ◽  
The Matrix

Abstract Background The Solus One Salmonella immunoassay utilizes Salmonella specific selective media and automated liquid handling, for the rapid and specific detection of Salmonella species in select food types. Objective The candidate method was evaluated using 375 g test portions in an unpaired study design for a single matrix, instant non-fat dry milk (NFDM) powder. Method The matrix was compared to the United States Food and Drug Administration/Bacteriological Analytical Manual (FDA/BAM) Chapter 5 Salmonella reference method. Eleven participants from 10 laboratories within academia and industry, located within the United States, Mexico, South Africa, Germany, and the United Kingdom, contributed data for the collaborative study. Three levels of contamination were evaluated for each matrix: an uninoculated control level [0 colony forming units (CFU)/test portion], a low inoculum level (0.2–2 CFU/test portion) and a high inoculum level (2–5 CFU/test portion). Statistical analysis was conducted according to the Probability of Detection (POD) statistical model. Results Results obtained for the low inoculum level test portions produced a dLPOD value with a 95% confidence interval between the candidate method confirmed (both alternative and conventional confirmation procedures) and the reference method of 0.07 (−0.02, 0.15). Conclusions The dLPOD results indicate equivalence between the candidate method and the reference method for the matrix evaluated and the method demonstrated acceptable inter-laboratory reproducibility as determined in the collaborative evaluation. False positive and false negative rates were determined for the matrix and produce values of <2%. Highlights Based on the data generated, the method demonstrated acceptable inter-laboratory reproducibility data and statistical analysis.

Evaluation of the 3M™ Molecular Detection Assay (MDA) 2 – Listeria monocytogenes for the Detection of Listeria monocytogenes in a Variety of Foods and Select Environmental Surfaces: Collaborative Study, First Action 2016.08

2017 ◽  
Vol 100 (2) ◽  
pp. 454-469
Author(s):  
Patrick Bird ◽  
Jonathan Flannery ◽  
Erin Crowley ◽  
James Agin ◽  
David Goins ◽  
...  
Keyword(s):  
Listeria Monocytogenes ◽  
Confidence Interval ◽  
Molecular Detection ◽  
Reference Method ◽  
Probability Of Detection ◽  
Chicken Breast ◽  
Inoculum Level ◽  
Test Portion ◽  
Environmental Surfaces ◽  
Detection Assay

Abstract The 3M™ Molecular Detection Assay (MDA) 2 – Listeria monocytogenes uses loop-mediated isothermal amplification of unique DNA target sequences combined with bioluminescence to rapidly detect Listeria monocytogenes in a broad range of food types and on environmental surfaces. Using an unpaired study design, technicians from 13 laboratories located in the United States and Canada compared the 3M MDA 2 – Listeria monocytogenes to the U.S. Department of Agriculture Food Safety Inspection Service Microbiology Laboratory Guidebook Chapter 8.09 “Isolation and Identification of Listeria monocytogenes from Red Meat, Poultry, and Egg Products, and Environmental Samples” reference method for the detection of L. monocytogenes in deli turkey and raw chicken breast fillet. Each matrix was evaluated at three levels of contamination: an uninoculated control level (0 CFU/test portion), a low inoculum level (0.2–2 CFU/test portion), and a high inoculum level (2–5 CFU/test portion). Statistical analysis was conducted according to the probability of detection (POD) statistical model. Results obtained for the low inoculum level test portions produced a difference in the collaborating laboratory POD (dLPOD) value of 0.04 with a 95% confidence interval of (−0.08, 0.17) for deli turkey, indicating that the difference between methods was not statistically significant at the 0.05 probability level. For raw chicken breast fillet, a dLPOD value of 0.16 with a 95% confidence interval of (0.04, 0.28) indicated a statistically significant difference, with an observed higher proportion of positive results by the candidate method compared to the reference method.

Evaluation of 3M™ Molecular Detection Assay (MDA) Listeria monocytogenes for the Detection of Listeria monocytogenes in Selected Foods and Environmental Surfaces: Collaborative Study, First Action 2014.07

2015 ◽  
Vol 98 (4) ◽  
pp. 980-992
Author(s):  
Patrick Bird ◽  
Jonathan Flannery ◽  
Erin Crowley ◽  
James Agin ◽  
David Goins ◽  
...  
Keyword(s):  
Listeria Monocytogenes ◽  
Environmental Samples ◽  
Molecular Detection ◽  
Collaborative Study ◽  
Probability Of Detection ◽  
Cottage Cheese ◽  
Inoculum Level ◽  
Test Portion ◽  
Detection Assay ◽  
Stressed Cells

Abstract The 3M™ Molecular Detection Assay (MDA) Listeria monocytogenes combines isothermal amplification and bioluminescence to detect Listeria monocytogenes with high specificity and efficiency in select foods and environmental samples. The 3M MDA Listeria monocytogenes method was evaluated using an unpaired study design in a multilaboratory collaborative study to the U.S. Department of Agriculture, Food Safety and Inspection Service Microbiology Laboratory Guidebook 8.09 (2011) Isolation and Identification of Listeria monocytogenes from Red Meat, Poultry, and Egg Products and Environmental Samples for deli turkey, and the AOAC Official Method of AnalysisSM 993.12 Listeria monocytogenes in Milk and Dairy Products for full-fat (4% milk fat) cottage cheese following the current AOAC guidelines. A total of 16 laboratories located in the continental United States and Canada participated in this collaborative study. For deli turkey, 125 g test portions were evaluated using heat-stressed cells by each method. For full-fat cottage cheese, 25 g test portions were evaluated using nonheat-stressed cells. Each matrix had three inoculation levels: an uninoculated control level (0 CFU/test portion), and two levels artificially contaminated with L. monocytogenes, a low inoculum level (0.2–2 CFU/test portion) and a high inoculum level (2–5 CFU/test portion). In total, 1584 unpaired replicate samples were analyzed. Statistical analysis was conducted according to the probability of detection (POD) model. Results obtained for the low inoculum level full-fat cottage cheese test portions produced a difference in cross-laboratory POD (dLPOD) value of –0.08 with a 95% confidence interval (CI) of (–0.20, 0.05). For the low-level deli turkey test portions, a dLPOD value of –0.02 with a 95% CI of (–0.14, 0.11) was obtained.

Evaluation of the 3M™ Petrifilm™ Salmonella Express System for the Detection of Salmonella Species in Selected Foods: Collaborative Study

2014 ◽  
Vol 97 (6) ◽  
pp. 1563-1575 ◽  
Author(s):  
Patrick Bird ◽  
Jonathan Flannery ◽  
Erin Crowley ◽  
James Agin ◽  
David Goins ◽  
...  
Keyword(s):  
Collaborative Study ◽  
Control Level ◽  
Ground Beef ◽  
Reference Method ◽  
Probability Of Detection ◽  
Isolation And Identification ◽  
Inoculum Level ◽  
Test Portion ◽  
Dog Food ◽  
The U.S

Abstract The 3M™ Petrifilm™Salmonella Express (SALX) System is a simple, ready-to-use chromogenic culture medium system for the rapid qualitative detection and biochemical confirmation of Salmonella spp. in food and food process environmental samples. The 3M Petrifilm SALX System was compared using an unpaired study design in a multilaboratory collaborative study to the U.S. Department of Agriculture/Food Safety and Inspection Service (USDA/FSIS) Microbiology Laboratory Guidebook (MLG) 4.07 (2013) Isolation and Identification of Salmonella from Meat, Poultry, Pasteurized Egg and Catfish Products and Carcass and Environmental Sponges for raw ground beef and the U.S. Food and Drug Administration Bacteriological Analytical Manual (FDA/BAM) Chapter 5, Salmonella (2011) reference method for dry dog food following the current AOAC validation guidelines. For this study, a total of 17 laboratories located throughout the continental United States evaluated 1872 test portions. For the 3M Petrifilm SALX System, raw ground beef was analyzed using 25 g test portions, and dry dog food was analyzed using 375 g test portions. For the reference methods, 25 g test portions of each matrix were analyzed. The two matrices were artificially contaminated with Salmonella at three inoculation levels: an uninoculated control level (0 CFU/test portion), a low inoculum level (0.2–2 CFU/test portion), and a high inoculum level (2–5 CFU/test portion). Each inoculation level was statistically analyzed using the probability of detection statistical model. For the raw ground beef and dry dog food test portions, no significant differences at the 95% confidence interval were observed in the number of positive samples detected by the 3M Petrifilm SALX System versus either the USDA/FSIS-MLG or FDA/BAM methods.

scholarly journals Evaluation of the iQ-Check®Salmonella II Assay in Select Foods: Collaborative Study, First Action 2017.06

2018 ◽  
Vol 101 (4) ◽  
pp. 1043-1057
Author(s):  
Patrick Bird ◽  
M Joseph Benzinger ◽  
Benjamin Bastin ◽  
Erin Crowley ◽  
James Agin ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Collaborative Study ◽  
Reference Method ◽  
The United States ◽  
Probability Of Detection ◽  
Milk Chocolate ◽  
Inoculum Level ◽  
Test Portion ◽  
Dog Food ◽  
Interlaboratory Reproducibility

Abstract The iQ-Check Salmonella II Real-Time PCR test kit utilizes Salmonella-specific oligonucleotide probes and primers for the rapid and specific detection of Salmonella species in select food types. The alternative method was evaluated by using 375 g test portions in an unpaired study design for two matrices, milk chocolate and dry dog food. Each matrix was compared with the U.S. Food and Drug Administration Chapter 5 Salmonella reference method. Fourteen technicians from 12 laboratories, including academia and industry, located within the United States and Canada participated in the collaborative study. Three levels of contamination were evaluated for each matrix: an uninoculated control level (0 CFU/test portion), a low inoculum level (0.2–2 CFU/test portion), and a high inoculum level (2–5 CFU/test portion). The statistical analysis was conducted according to the Probability of Detection (POD) statistical model. The results obtained for the low inoculum level test portions produced a difference in the candidate presumptive and confirmatory results (dLPOD) value with a 95% confidence interval of −0.05, (−0.15, 0.06) for the milk chocolate and 0.10, (−0.01, 0.21) for the dry dog food. The dLPOD results indicate an equivalence between the candidate method and reference method for the matrices evaluated, and the method demonstrated acceptable interlaboratory reproducibility as determined in the collaborative evaluation. False positive and false negative rates were determined for each matrix and produce values of <2%. Based on the data generated, the method demonstrated acceptable interlaboratory reproducibility data and statistical analysis.

Evaluation of VIDAS® UP Salmonella (SPT) Assay for the Detection of Salmonella in a Variety of Foods and Environmental Samples: Collaborative Study

2013 ◽  
Vol 96 (4) ◽  
pp. 808-821 ◽  
Author(s):  
Patrick Bird ◽  
Kiel Fisher ◽  
Megan Boyle ◽  
Travis Huffman ◽  
Marc Juenger ◽  
...  
Keyword(s):  
Confidence Intervals ◽  
Environmental Samples ◽  
Collaborative Study ◽  
Reference Method ◽  
The United States ◽  
Probability Of Detection ◽  
Inoculum Level ◽  
Test Portion ◽  
Low Level ◽  
Significant Difference

Abstract The VIDAS® UP Salmonella (SPT) uses recombinant phage proteins to detect Salmonella species in human and animal food products and production environmental samples after 18–26 h of enrichment. The VIDAS SPT assay is performed with the automated VIDAS or mini-VIDAS instruments. The VIDAS SPT method was compared in a multilaboratory collaborative study to the U.S. Department of Agriculture/Food Safety and Inspection Service-Microbiology Laboratory Guidebook (USDA/FSIS-MLG) 4.05 (2011) Isolation and Identification of Salmonella from Meat, Poultry, Pasteurized Egg and Catfish Products reference method following the current AOAC guidelines. A total of 15 laboratories representing government, academia, and industry throughout the United States participated. One matrix, raw ground beef, was analyzed using two different test portion sizes, 25 and 375 g. Each test portion was artificially contaminated with Salmonella at three inoculation levels, an uninoculated control level (0 CFU/test portion), a low inoculum level (0.2–2 CFU/test portion), and a high inoculum level (2–5 CFU/test portion). In this study, 1656 unpaired replicate samples were analyzed. Of those unpaired replicates, 476 were presumptive positive by the VIDAS method, with 475 confirmed positive by the traditional confirmation procedures and 476 confirmed positive by an alternative confirmation procedure. There were 411 confirmed positive replicates by the USDA/FSIS-MLG reference method. Statistical analysis was conducted according to the probability of detection (POD). For the low-level 375 g test portions, the following dLPOD values, with 95% confidence intervals, were obtained: 0.01 (−0.12, +0.15) for samples confirmed following the traditional confirmation; 0.02 (−0.18, +0.2) for samples confirmed following traditional confirmation on IBISA and ASAP; and 0.03 (−0.18, +0.24) for samples confirmed following the alternative confirmation on IBISA and ASAP. For the low-level 25 g test portions, the following dLPOD values, with 95% confidence intervals, were obtained: 0.41, (0.32, +0.49) for samples confirmed following the traditional confirmation, the traditional confirmation on IBISA and ASAP, and the alternative confirmation on IBISA and ASAP. With 0.0 within the confidence intervals for the 375 g test portions, there was no statistically significant difference in the number of positive samples detected by the VIDAS SPT method and the USDA/FSIS-MLG method at the 0.05 level. For the 25 g test portions, a statistically significant difference was observed between the VIDAS SPT method and the reference method for the low inoculum level, where the VIDAS SPT method recovered a higher number of positive results than the reference method. It is recommended that the VIDAS SPT method with the optional ASAP and IBISA agar confirmation method be adopted for Official First Action status for the detection of Salmonella in a variety of foods and environmental samples.

scholarly journals Evaluation of the GENE-UP ®E. coli O157:H7 Method for the Detection of E. coli O157:H7 in Select Foods: Collaborative Study, 2019.03

2020 ◽  
Vol 103 (5) ◽  
pp. 1338-1347
Author(s):  
Ronald Johnson ◽  
John Mills ◽  
Jean-Louis Pittet ◽  
Maryse Rannou ◽  
Patrick Bird ◽  
...  
Keyword(s):  
Confidence Interval ◽  
Collaborative Study ◽  
Control Level ◽  
Reference Method ◽  
Probability Of Detection ◽  
Contamination Level ◽  
Test Portion ◽  
E Coli ◽  
Significant Difference ◽  
Contamination Levels

Abstract Background The GENE-UP®E. coli O157:H7 2 (ECO 2) assay (Performance Tested MethodSM 121805) incorporates Fluorescence Resonance Energy Transfer hybridization probes into its proprietary PCR technology for the rapid detection of E. coli O157:H7 in select foods. Objective The purpose of this validation was to evaluate the method’s interlaboratory performance and submit the result to AOAC INTERNATIONAL for adoption as First Action Official MethodSM for the detection of E. coli O157:H7 in select foods. Method The GENE-UP® method was evaluated in a multi-laboratory study as part of the MicroVal validation process using unpaired test portions for one food matrix, raw milk cheese (Comté, 34% fat, 0.8% salt). The candidate method was compared to the ISO 16654:2001 reference method. Fourteen participants from 13 laboratories throughout the European Union participated. Three levels of contamination were evaluated: a non-inoculated control level (0 colony-forming units (CFU)/test portion), a low contamination level (∼5 CFU/test portion), and a high contamination level (∼10 CFU/test portion). Data from that study were analyzed according to the Probability of Detection (POD) statistical model as presented in the AOAC validation guidelines. The difference in laboratory POD (dLPODC) values with 95% confidence interval across collaborators was calculated for each level between the candidate and reference method results, and between the candidate presumptive and confirmed results. Results The dLPODC values with 95% confidence interval were; 0.00 (–0.04, 0.04), 0.27 (0.04, 0.49), and 0.17 (0.01, 0.33) for the non-inoculated, low and high contamination levels respectively. Conclusions The dLPODC results indicate a significant difference between the candidate method and the reference method for both the low and high contamination levels, with the candidate method producing higher recovery of the target organism at both levels. Highlights The GENE-UP E. coli O157:H7 assay provides industry with a rapid, accurate detection method for E. coli O157:H7 in a broad range of foods.

Evaluation of 3M Molecular Detection Assay (MDA) 2–Listeria for the Detection of Listeria Species in Select Foods and Environmental Surfaces: Collaborative Study, First Action 2016.07

2017 ◽  
Vol 100 (1) ◽  
pp. 82-98
Author(s):  
Patrick Bird ◽  
Jonathan Flannery ◽  
Erin Crowley ◽  
James Agin ◽  
David Goins ◽  
...  
Keyword(s):  
Molecular Detection ◽  
Collaborative Study ◽  
Reference Method ◽  
Probability Of Detection ◽  
Chicken Breast ◽  
Test Portion ◽  
Listeria Species ◽  
Environmental Surfaces ◽  
Detection Assay ◽  
Significant Difference

Abstract 3M Molecular Detection Assay (MDA) 2–Listeria uses loop-mediated isothermal amplification and bioluminescence detection to rapidly detect Listeria species in a broad range of food types and environmental surfaces. Using an unpaired study design, MDA 2–Listeria was compared with the U.S. Department of Agriculture, Food Safety and Inspection Service's Microbiology Laboratory Guidebook Chapter 8.09 “Isolation and identification of Listeria monocytogenes from red meat, poultry and egg products, and environmental samples” reference method for the detection of Listeria in deli turkey and raw chicken breast fillet. Technicians from 13 laboratories located within the continental United States and Canada participated in the collaborative study. Each matrix was evaluated at three levels of contamination: uninoculated control (0 CFU/test portion), low inoculum (0.2–2 CFU/test portion), and high inoculum (2–5 CFU/test portion). Statistical analysis was conducted according to the probability of detection (POD) statistical model. Results obtained for the low-inoculum-level test portions produced a difference between two laboratory POD values (dLPOD) with 95% confidence intervals of 0.04 (–0.08, 0.17) for deli turkey, indicating the difference between the methods was not statistically significant at the P = 0.05. For raw chicken breast fillet, a dLPOD value with 95% confidence interval of 0.16 (0.04, 0.28) indicated a statistically significant difference between the two methods, with an observed higher proportion of positive results by the candidate method than the reference method.

Evaluation of the GENE-UP® EHEC Detection Method for the Detection of Enterohemorrhagic E. coli in Select Foods: Collaborative Study: First Action Method 2020.06

2021 ◽  
Author(s):  
Ronald Johnson ◽  
John Mills ◽  
Jean-Louis Pittet ◽  
Maryse Rannou ◽  
Patrick Bird
Keyword(s):  
Detection Method ◽  
Collaborative Study ◽  
False Negative ◽  
Control Level ◽  
Reference Method ◽  
Probability Of Detection ◽  
Contamination Level ◽  
Official Method ◽  
Test Portion ◽  
E Coli

Abstract Background The GENE-UP® EHEC assay (Performance Tested MethodSM 121806) is a real-time PCR molecular detection method that utilizes Fluorescence Resonance Energy Transfer proprietary hybridization probes for the rapid detection of Enterohemorrhagic E. coli (EHEC) in select foods. Objective The purpose of this validation was to evaluate the method’s interlaboratory performance and submit the results to AOAC INTERNATIONAL for adoption as First Action Official Method of AnalysisSM for the detection of EHEC in select foods. Method The GENE-UP® method was evaluated in a multi-laboratory study as part of the MicroVal VALIDATION certification process using unpaired test portions for one food matrix, raw ground beef (85% lean). Collaborators evaluated the candidate method using either an automated or manual lysis procedure. The candidate method was compared to the ISO/TS 13136:2012 method. Data from 17 participants from 15 laboratories throughout the European Union was evaluated. Three levels of contamination were evaluated: a non-inoculated control level (0 CFU/test portion), a low contamination level (∼1 CFU/test portion) and a high contamination level (∼10 CFU/test portion). Data from the study were analyzed according to the probability of detection (POD) statistical model. Results The dLPODC values with 95% confidence interval between the candidate and reference method results were; –0.01 (–0.04, 0.02), 0.23 (0.07, 0.39) and 0.06 (0.01, 0.12) for the non-inoculated, low and high contamination levels, respectively. Conclusion For the candidate method, values obtained for repeatability and reproducibility were similar to the reference method and indicated minimal variation between samples or between laboratories. No discrepant results (false positive or false negative) were observed for each contamination. A statistical difference was calculated between the candidate and reference method at the low and high inoculation levels, with the candidate method detecting a higher number of positive samples indicating a higher sensitivity than the reference method. No differences in the recovery of the target analyte were observed between the manual and automated lysis procedures. Highlights The GENE-UP EHEC Detection Method provides end users a rapid, easy-to-use workflow for the detection of EHEC in food matrices.

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