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

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.

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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

Journal of AOAC International ◽

10.1093/jaoacint/qsab018 ◽

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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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

Journal of AOAC International ◽

10.1093/jaoacint/qsaa103 ◽

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.

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

Journal of AOAC International ◽

10.1093/jaoacint/qsaa071 ◽

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.

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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

Journal of AOAC International ◽

10.1093/jaoacint/qsaa079 ◽

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.

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

Journal of AOAC International ◽

10.5740/jaoacint.cs2013_01 ◽

2013 ◽

Vol 96 (4) ◽

pp. 808-821 ◽

Cited By ~ 3

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.

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

Journal of AOAC International ◽

10.5740/jaoacint.14-120 ◽

2014 ◽

Vol 97 (6) ◽

pp. 1563-1575 ◽

Cited By ~ 3

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.

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Detection of Salmonella species in a Variety of Foods by the DuPont™ BAX® System Real-Time PCR Assay for Salmonella: First Action 2013.02

Journal of AOAC International ◽

10.5740/jaoacint.13-407 ◽

2014 ◽

Vol 97 (3) ◽

pp. 868-875 ◽

Cited By ~ 1

Author(s):

F Morgan Wallace ◽

Bridget Andaloro ◽

Dawn Fallon ◽

Nisha Corrigan ◽

Stephen Varkey ◽

...

Keyword(s):

Real Time ◽

Real Time Pcr ◽

Orange Juice ◽

Collaborative Study ◽

Reference Method ◽

Probability Of Detection ◽

Test Method ◽

Pcr Assay ◽

Test Portion ◽

Significant Difference

Abstract A multilaboratory study was conducted to evaluate the ability of the DuPont™ BAX® System Real-Time PCR Assay for Salmonella to detect the target species in a variety of foods and environmental surfaces. Internal validation studies were performed by DuPont Nutrition & Health on 24 different sample types to demonstrate the reliability of the test method among a wide variety of sample types. Two of these matrixes—pork and turkey frankfurters and pasteurized, not-from-concentrate orange juice without pulp—were each evaluated in 14 independent laboratories as part of the collaborative study to demonstrate repeatability and reproducibility of the internal laboratory results independent of the end user. Frankfurter samples were evaluated against the U. S. Department of Agriculture, Food Safety and Inspection Service reference method as a paired study, while orange juice samples were evaluated against the U. S. Food and Drug Administration reference method as an unpaired study, using a proprietary media for the test method. Samples tested in this study were artificially inoculated with a Salmonella strain at levels expected to produce low (0.2–2.0 CFU/test portion) or high (5 CFU/test portion) spike levels on the day of analysis. For each matrix, the collaborative study failed to show a statistically significant difference between the candidate method and the reference method using the probability of detection statistical model.

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Evaluation of the MC-Media PadTM Yeast and Mold Device for the Enumeration of Yeast and Mold: Collaborative Study, First Action 2018.02

Journal of AOAC International ◽

10.5740/jaoacint.18-0262 ◽

2019 ◽

Vol 102 (4) ◽

pp. 1138-1144

Author(s):

Patrick Bird ◽

Benjamin Bastin ◽

Dane Brooks ◽

Erin Crowley ◽

James Agin ◽

...

Keyword(s):

Collaborative Study ◽

Control Level ◽

Reference Method ◽

Food Products ◽

Plate Count ◽

Contamination Level ◽

Juice Concentrate ◽

Uninoculated Control ◽

The Difference ◽

Contamination Levels

Abstract Background: The MC-Media Pad™ Yeast and Mold (YM) is a ready-to use culture device that combines a test pad coated with medium and water-absorption polymers that is designed for the rapid quantification of yeast and mold in food products. Objective: The MC-Media Pad YM was compared with the U.S. Food and Drug Administration (FDA) Bacteriological Analytical Manual (BAM) for the enumeration of yeast and mold in frozen orange juice concentrate. Methods: The candidate method was evaluated using a paired study design in a multilaboratory collaborative study following the current AOAC Validation Guidelines. Three target contamination levels (low, 10–100 CFU/g; medium, 100–1000 CFU/g; and high 1000–10 000 CFU/g) and an uninoculated control level (0 CFU/g) were evaluated. MC-Media Pad YM devices were enumerated after 48 and 72 h of incubation. Results: Plate count obtained by both methods were log-transformed and the difference of means (including 95% confidence intervals), repeatability SD, and SD were determined for each contamination level. Conclusions: No statistical difference was observed between the MC-Media Pad YM (for both 48 and 72 h) and the FDA BAM for each contamination level. Highlights: The new method offers a convenient alternative to the reference method (FDA BAM) for detection of yeast and mold contamination in food products, yielding reliable and comparable results in 48 h compared to 5 days for the reference method.

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Evaluation of the GENE-UP®Cronobacter Method for the Detection of Cronobacter Species in Select Foods and Environmental Surfaces: Collaborative Study, First Action 2019.01

Journal of AOAC International ◽

10.5740/jaoacint.19-0122 ◽

2020 ◽

Vol 103 (1) ◽

pp. 184-196

Author(s):

Ronald Johnson ◽

John Mills ◽

Jean-Louis Pittet ◽

Maryse Rannou ◽

Patrick Bird ◽

...

Keyword(s):

Confidence Intervals ◽

Rapid Detection ◽

Reference Method ◽

Probability Of Detection ◽

Contamination Level ◽

Test Portion ◽

Environmental Surfaces ◽

Wide Range ◽

Significant Difference ◽

Cronobacter Species

Abstract Background: The GENE-UP®Cronobacter assay (Performance Tested MethodSM 081801) is a real-time PCR technology for the rapid detection of Cronobacter species in select 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 a First Action Official MethodSM for the detection of Cronobacter species in select foods and environmental surfaces. Method: The GENE-UP method was evaluated in a multilaboratory study as part of the AFNOR NF VALIDATION certification process (NF102) following ISO 16140-2:2016 using unpaired test portions for one food matrix, reconstituted infant formula containing probiotics. The candidate method was compared to the ISO 22964:2017 reference method. Sixteen participants from fifteen laboratories throughout the European Union participated. Three levels of contamination were evaluated: a noninoculated control level (0 CFU/target test portion), a low contamination level (approximately 2 CFU/target test portion), and a high contamination level (approximately 10 CFU/target 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 intervals 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 intervals were 0.00 (–0.03, 0.03), –0.08 (–0.19, 0.02), and 0.00 (–0.03, 0.03) for the noninoculated, low, and high contamination levels, respectively. Conclusions: The dLPODC results indicate no significant difference between the candidate method and the reference method or between presumptive and confirmed results for all three levels of contamination. Highlights: The GENE-UP Cronobacter assay provides industry with a rapid, easy to use method for the rapid detection of Cronobacter in a wide range of products and environmental samples.

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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

Journal of AOAC International ◽

10.5740/jaoacint.16-0236 ◽

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.

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