Evaluation of 3M™ Molecular Detection Assay (MDA) Salmonella for the Detection of Salmonella in Selected Foods: Collaborative Study

2013 ◽  
Vol 96 (6) ◽  
pp. 1325-1335 ◽  
Author(s):  
Patrick Bird ◽  
Kiel Fisher ◽  
Megan Boyle ◽  
Travis Huffman ◽  
M Joseph Benzinger, Jr ◽  
...  
Keyword(s):  
Confidence Intervals ◽  
Molecular Detection ◽  
Collaborative Study ◽  
Ground Beef ◽  
Probability Of Detection ◽  
Inoculum Level ◽  
Test Portion ◽  
Low Level ◽  
Dog Food ◽  
Detection Assay

Abstract The 3M™ Molecular Detection Assay (MDA) Salmonella is used with the 3M™ Molecular Detection System for the detection of Salmonella spp. in food, food-related, and environmental samples after enrichment. The assay utilizes loop-mediated isothermal amplification to rapidly amplify Salmonella target DNA with high specificity and sensitivity, combined with bioluminescence to detect the amplification. The 3M MDA Salmonella method was compared 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 (USDA/FSIS-MLG 4.05), Isolation and Identification of Salmonella from Meat, Poultry, Pasteurized Egg and Catfish Products for raw ground beef and the U.S. Food and Drug Administration/Bacteriological Analytical Manual (FDA/BAM) Chapter 5 Salmonella reference method for wet dog food following the current AOAC guidelines. A total of 20 laboratories participated. For the 3M MDA Salmonella method, raw ground beef was analyzed using 25 g test portions, and wet dog food was analyzed using 375 g test portions. For the reference methods, 25 g test portions of each matrix were analyzed. Each matrix 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, 1512 unpaired replicate samples were analyzed. Statistical analysis was conducted according to the probability of detection (POD). For the low-level raw ground beef test portions, the following dLPOD (difference between the POD of the reference and candidate method) values with 95% confidence intervals were obtained: –0.01 (–0.14, +0.12). For the low-level wet dog food test portions, the following dLPOD with 95% confidence intervals were obtained: –0.04 (–0.16, +0.09). No significant differences were observed in the number of positive samples detected by the 3M MDA Salmonella method versus either the USDA/FSIS-MLG or FDA/BAM methods.

Evaluation of Modification of the 3M™ Molecular Detection Assay (MDA) Salmonella Method (2013.09) for the Detection of Salmonella in Selected Foods: Collaborative Study

2014 ◽  
Vol 97 (5) ◽  
pp. 1329-1342 ◽  
Author(s):  
Patrick Bird ◽  
Kiel Fisher ◽  
Megan Boyle ◽  
Travis Huffman ◽  
M Joseph Benzinger ◽  
...  
Keyword(s):  
Confidence Intervals ◽  
Molecular Detection ◽  
Collaborative Study ◽  
Ground Beef ◽  
Inoculum Level ◽  
Test Portion ◽  
Low Level ◽  
Dog Food ◽  
Detection Assay ◽  
The U.S

Abstract The 3M™ Molecular Detection Assay (MDA) Salmonella utilizes isothermal amplification of nucleic acid sequences with high specificity, efficiency, rapidity and bioluminescence to detect amplification of Salmonella spp. in food, food-related, and environmental samples after enrichment. A method modification and matrix extension study of the previously approved AOAC Official MethodSM 2013.09 was conducted, and approval of the modification was received on March 20, 2014. Using an unpaired study design in a multilaboratory collaborative study, the 3M MDA Salmonella method was compared to the U.S. Department of Agriculture/Food Safety and Inspection Service (USDA/FSIS) Microbiology Laboratory Guidebook (MLG) 4.05 (2011), Isolation and Identification of Salmonella from Meat, Poultry, Pasteurized Egg, and Catfish Products for raw ground beef and the U.S. Food and Drug Administration (FDA)/Bacteriological Analytical Manual (BAM) Chapter 5, Salmonella reference method for wet dog food following the current AOAC guidelines. A total of 20 laboratories participated. For the 3M MDA Salmonella method, raw ground beef was analyzed using 25 g test portions, and wet dog food was analyzed using 375 g test portions. For the reference methods, 25 g test portions of each matrix were analyzed. Each matrix 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, 1512 unpaired replicate samples were analyzed. Statistical analysis was conducted according to the probability of detection (POD). For the low-level raw ground beef test portions, the following dLPOD (difference between the LPODs of the reference and candidate method) values with 95% confidence intervals were obtained: –0.01 (–0.14, +0.12). For the low-level wet dog food test portions, the following dLPOD with 95% confidence intervals were obtained: –0.04 (–0.16, +0.09). No significant differences were observed in the number of positive samples detected by the 3M MDA Salmonella method versus either the USDA/FSIS-MLG or FDA/BAM methods.

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.

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 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 the 3M™ Molecular Detection Assay (MDA) 2 – Cronobacter for the Detection of Cronobacter species in Select Foods and Environmental Surfaces: Collaborative Study, First Action 2018.01

2019 ◽  
Vol 102 (1) ◽  
pp. 108-117
Author(s):  
Patrick Bird ◽  
M Joseph Benzinger ◽  
Ben Bastin ◽  
Erin Crowley ◽  
James Agin ◽  
...  
Keyword(s):  
Molecular Detection ◽  
Collaborative Study ◽  
The United States ◽  
Probability Of Detection ◽  
Powdered Infant Formula ◽  
Inoculum Level ◽  
Detection Assay ◽  
Cronobacter Species ◽  
The Difference ◽  
United States Mexico

Abstract The 3M™ Molecular Detection Assay (MDA) 2 – Cronobacter combines the use of loop-mediated isothermal amplification to rapidly amplify nucleic acid sequences while using bioluminescence to detect the amplification. Using a paired study design, the MDA 2 – Cronobacter was compared with ISO 22964:2017 for the detection of Cronobacter species in powdered infant formula containing probiotics. Technicians from 11 laboratories from the United States, Mexico, and Croatia participated. Collaborators received test portions with three levels of contamination. 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 POD values obtained from combining all valid collaborator POD data values with 95% confidence intervals of –0.01, –0.12, and 0.10, indicating that the difference between methods was not statistically significant at the 0.05 probability level.

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 3M™ Molecular Detection Assay (MDA) 2 – Salmonella for the Detection of Salmonella spp. in Select Foods and Environmental Surfaces: Collaborative Study, First Action 2016.01

2016 ◽  
Vol 99 (4) ◽  
pp. 980-997 ◽  
Author(s):  
Patrick Bird ◽  
Jonathan Flannery ◽  
Erin Crowley ◽  
James R Agin ◽  
David Goins ◽  
...  
Keyword(s):  
Environmental Samples ◽  
Molecular Detection ◽  
Peanut Butter ◽  
Collaborative Study ◽  
Reference Method ◽  
Salmonella Spp ◽  
Inoculum Level ◽  
Test Portion ◽  
Detection Assay ◽  
The U.S

Abstract The 3M™ Molecular Detection Assay (MDA) 2 – Salmonella uses real-time isothermal technology for the rapid and accurate detection of Salmonella spp. from enriched select food, feed, and food-process environmental samples. The 3M MDA 2 – Salmonella was evaluated in a multilaboratory collaborative study using an unpaired study design. The 3M MDA 2 – Salmonella was compared to the U.S. Food and Drug Administration Bacteriological Analytical Manual Chapter 5 reference method for the detection of Salmonella in creamy peanut butter, and to the U.S. Department of Agriculture, Food Safety and Inspection Service Microbiology Laboratory Guidebook Chapter 4.08 reference method “Isolation and Identification of Salmonella from Meat, Poultry, Pasteurized Egg and Catfish Products and Carcass and Environmental Samples” for the detection of Salmonella in raw ground beef (73% lean). Technicians from 16 laboratories located within the continental United States participated. 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 difference in collaborator POD values of 0.03 (95% confidence interval, −0.10 to 0.16) for raw ground beef and 0.06 (95% confidence interval, −0.06 to 0.18) for creamy peanut butter, indicating no statistically significant difference between the candidate and reference methods.

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.

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