3M™ Petrifilm™ Rapid Yeast and Mold Count Plate Method for the Enumeration of Yeast and Mold on Selected Surfaces: AOAC Official Method 2014.05.

BACKGROUND: The 3M™ Petrifilm™ Rapid Yeast and Mold Count (RYM) Plate contains nutrients supplemented with antibiotics, a cold-water-soluble gelling agent, and an indicator system that facilitates yeast and mold enumeration in 48-60 h. OBJECTIVE: The objective of this study is to evaluate the 3M Petrifilm RYM Plate in a matrix extension study for the enumeration of yeast and mold on stainless steel, sealed concrete, and rubber surfaces. METHODS: The 3M Petrifilm RYM Plate was compared to the U.S. Food and Drug Administration Bacteriological Analytical Manual, Ch. 18: Yeasts, Molds and Mycotoxins in a paired matrix study for enumeration of yeast and mold on stainless steel, sealed concrete, and rubber environmental surfaces. RESULTS: The 3M Petrifilm RYM Plate demonstrated equivalent performance to the reference method for enumeration of yeast and mold from stainless steel, sealed concrete, and rubber environmental surfaces. There were no significant statistical differences between the 3M Petrifilm RYM Plate and reference method results for the three matrixes evaluated. CONCLUSION: The 3M Petrifilm RYM Plate is an effective plating method for enumerating yeast and mold when analyzing stainless steel, sealed concrete, and rubber surfaces. HIGHLIGHTS: The 3M Petrifilm RYM Plate method allows the user to obtain accurate results within 48-60 h in the matrices evaluated for the presence of yeast and mold when incubated at 25 ± 1°C or 28 ± 1°C. Interpretation and colony counting was straightforward and the 3M Petrifilm RYM Plate method required no additional agar or Petri dishes, creating an easier workflow by cutting down on supplies, sample plating time, and most noticeably, occupying less space in the incubator.

3M™ Petrifilm™ Rapid Aerobic Count (RAC) Plate Method for the Enumeration of Aerobic Bacteria on Selected Surfaces: AOAC Official MethodSM 2015.13.

BACKGROUND: The 3M™ Petrifilm™ Rapid Aerobic Count (RAC) Plate is a sample-ready culture medium system designed to facilitate colony enumeration in 24 h (48 h for dry powders) for selected food and environmental surfaces. OBJECTIVE: The objective of this study is to evaluate the 3M Petrifilm RAC Plate in a matrix extension study for the enumeration of aerobic bacteria on stainless steel, sealed concrete, and rubber surfaces. METHOD: The 3M Petrifilm RAC Plate was compared to the U.S. Food and Drug Administration Bacteriological Analytical Manual, Ch. 3 (January 2001): Aerobic Plate Count in a paired matrix study for enumeration of aerobic bacteria on stainless steel, sealed concrete, and rubber environmental surfaces. RESULTS: The 3M Petrifilm RAC Plate showed no statistically significant differences when compared to the reference method for enumeration of aerobic bacteria from stainless steel, sealed concrete, and rubber environmental surfaces. There were no significant statistical differences between the 3M Petrifilm RAC Plate and reference method results for the three matrixes evaluated. CONCLUSIONS: The 3M Petrifilm RAC Plate is an effective plating method for aerobic plate count when analyzing stainless steel, sealed concrete, and rubber surfaces. HIGHLIGHTS: The 3M Petrifilm RAC Plate is robust, quick, and simple to perform, providing enumerable colonies in 22 to 26 h after incubation when compared to the 48 h of the reference method. The small size of the Petrifilm Plate allows for less space to be occupied by plates in the incubators. The visual biochemical and enzymatic indicators make enumeration of colonies a simple task by presenting colonies in either a blue or red color.

Validation of the 3M™ Molecular Detection Assay 2-STEC Gene Screen (stx) for Detection of Shiga Toxin Gene (stx1 and/or stx2) in Dried Cannabis Flower and Dried Hemp Flower: AOAC Performance Tested MethodSM 071903.

BACKGROUND: The 3M™ Molecular Detection Assay 2-STEC Gene Screen (stx) method is based on gene amplification by the use of real-time loop-mediated isothermal amplification when used with the 3M Molecular Detection System for the rapid and specific detection of Shiga toxin gene (stx1 and/or stx2) from Shiga toxin-producing Escherichia coli (STEC) in enriched products. The 3M Molecular Detection Assay 2-STEC Gene Screen (stx) was approved as AOAC Performance Tested MethodSM Certificate No. 071903. OBJECTIVE: This matrix extension study evaluated the 3M Molecular Detection Assay 2-STEC Gene Screen (stx) method for detection of STECs in dried cannabis flower [>0.3% delta 9-tetrahydrocannabinol (THC)] and dried hemp flower (≤0.3% THC) at a 10 g test portion size. METHOD: Testing followed procedures outlined in 3M Molecular Detection Assay 2-STEC Gene Screen (stx) product instructions and Standard Method Performance Requirement (SMPR®) for Detection of Shiga Toxin-Producing Escherichia coli in Cannabis and Cannabis Products (AOAC SMPR 2020.012). The method was evaluated at low, high, and non-inoculated levels. RESULTS: Results showed no statistically significant difference between the presumptive positive 3M Molecular Detection Assay 2-STEC Gene Screen (stx) results and the SMPR 2020.012 recommended cultural confirmations. CONCLUSIONS: This study provides data that demonstrate the 3M Molecular Detection Assay 2-STEC Gene Screen (stx) is a reliable method for the rapid and specific detection of STECs in dried cannabis flower and dried hemp flower. HIGHLIGHTS: The 3M Molecular Detection Assay 2-STEC Gene Screen (stx) method is suitable for the rapid and specific detection of STECs in dried cannabis flower and dried hemp flower.

Validation of the 3M™ Molecular Detection Assay 2-STEC Gene Screen (stx and eae) for Detection of Shiga Toxin Gene (stx1 and/or stx2) and Intimin Gene (eae) in Dried Cannabis Flower and Dried Hemp Flower: AOAC Performance Tested MethodSM 071902.

BACKGROUND: The 3M™ Molecular Detection Assay 2-STEC Gene Screen (stx and eae) method is based on gene amplification by the use of real time loop-mediated isothermal amplification when used with the 3M Molecular Detection System for the rapid and specific detection of Shiga toxin gene (stx1 and/or stx2) and intimin gene (eae) from Shiga toxin-producing Escherichia coli (STEC) in enriched products. The 3M Molecular Detection Assay 2-STEC Gene Screen (stx and eae) was approved as AOAC Performance Tested MethodSM Certificate No. 071902. OBJECTIVE: This matrix extension study evaluated the 3M Molecular Detection Assay 2-STEC Gene Screen (stx and eae) method for detection of STECs in dried cannabis flower [>0.3% delta 9-tetrahydrocannabinol (THC)] and dried hemp flower (≤0.3% THC) at a 10 g test portion size. METHOD: Testing followed procedures outlined in 3M Molecular Detection Assay 2-STEC Gene Screen (stx and eae) product instructions and Standard Method Performance Requirements (SMPR®) for Detection of Shiga Toxin-Producing Escherichia coli in Cannabis and Cannabis Products (AOAC SMPR 2020.012). The method was evaluated at low, high, and non-inoculated levels. RESULTS: Results showed no statistically significant difference between the presumptive positive 3M Molecular Detection Assay 2-STEC Gene Screen (stx and eae) results and the SMPR 2020.012 recommended cultural confirmations. CONCLUSIONS: This study provides data that demonstrate the 3M Molecular Detection Assay 2-STEC Gene Screen (stx and eae) is a reliable method for the rapid and specific detection of STEC organisms in dried cannabis flower and dried hemp flower. HIGHLIGHTS: The 3M Molecular Detection Assay 2-STEC Gene Screen (stx and eae) method is suitable for the rapid and specific detection of STEC organisms in dried cannabis flower and dried hemp flower.

Validation of the 3MTM Molecular Detection Assay 2-Salmonella for detection of Salmonella in Dried Cannabis Flower and Dried Hemp Flower: AOAC Performance Tested MethodsSM 091501.

BACKGROUND: The 3M™ Molecular Detection Assay 2-Salmonella method is based on real-time loop-mediated isothermal amplification when used with the 3M Molecular Detection System for the rapid and specific detection of Salmonella in enriched products. The 3M Molecular Detection Assay 2-Salmonella was approved as AOAC INTERNATIONAL (AOAC) Performance Tested MethodSM (PTM) Certificate No. 091501 and as AOAC Official Method of AnalysisSM2016.01. OBJECTIVE: This matrix extension study evaluated the 3M Molecular Detection Assay 2-Salmonella for detection of Salmonella in dried cannabis flower [>0.3% delta 9-tetrahydrocannabinol (THC)] and dried hemp flower (≤0.3% THC) at a 10 g test portion size. METHOD: Matrix studies in dried cannabis and hemp flowers followed procedures outlined in 3M Molecular Detection Assay 2-Salmonella product instructions and Standard Method Performance Requirement (SMPR®) for Detection of Salmonella species in Cannabis and Cannabis Products (AOAC SMPR 2020.002). The method was evaluated at low, high, and non-contaminated levels. RESULTS: Results showed no statistically significant difference between the presumptive positive 3M Molecular Detection Assay 2-Salmonella results and the SMPR 2020.002 recommended cultural confirmations. CONCLUSIONS: This study demonstrates that the 3M Molecular Detection Assay 2-Salmonella is a reliable method for the rapid and specific detection of Salmonella in dried cannabis flower and dried hemp flower. HIGHLIGHTS: The 3M Molecular Detection Assay 2-Salmonella method is suitable for the rapid and specific detection of Salmonella in dried cannabis flower and dried hemp flower.

Validation of the 3M™ Molecular Detection Assay 2 - STEC Gene Screen (stx) for the Detection of Shiga Toxin Gene (stx1 and/or stx2) in Additional Matrixes: AOAC Performance Tested MethodSM 071903.

BACKGROUND: The 3M™ Molecular Detection Assay 2 - STEC Gene Screen (stx) method is based on gene amplification by the use of real-time loop-mediated isothermal amplification when used with the 3M Molecular Detection System for the rapid and specific detection of Shiga toxin gene (stx1 and/or stx2) from Shiga toxin-producing enterohemorrhagic Escherichia coli (STEC) in enriched foods. OBJECTIVE: The 3M Molecular Detection Assay 2 - STEC Gene Screen (stx) method was evaluated as a Level 2 method modification to add new matrixes to the certified claim: 25 g fresh raw ground beef (approximately 75% lean), 375 g raw beef trim (approximately 75% lean), 375 g fresh raw ground pork (approximately 70% lean), 375 g fresh raw poultry parts, and 25 g sprouts. METHODS: Matrix studies were conducted to assess the method's performance compared to the US Department of Agriculture Food Safety and Inspection Service Microbiology Laboratory Guidebook, 5C.00 for meat and poultry, and to the US Food and Drug Administration Bacteriological Analytical Manual, Ch. 4A for sprouts, using an unpaired study design. RESULTS: The 3M Molecular Detection Assay 2 - STEC Gene Screen (stx) method demonstrated no significant differences between presumptive and confirmed results or between candidate and reference method results for any of the matrices tested. CONCLUSION AND HIGHLIGHTS: The data collected in these studies demonstrate that the 3M Molecular Detection Assay 2 - STEC Gene Screen (stx) is a reliable method for the rapid and specific detection of STEC in fresh raw ground beef (approximately 75% lean), fresh raw beef trim (approximately 75% lean), fresh raw ground pork (approximately 70% lean), fresh raw poultry parts, and sprouts.

Validation of the 3M™ Molecular Detection Assay 2 - STEC Gene Screen (stx and eae) for the Detection of Shiga Toxin Gene (stx1 and/or stx2) and Intimin Gene (eae): AOAC Performance Tested MethodSM 071902.

BACKGROUND: The 3M™ Molecular Detection Assay 2 - STEC Gene Screen (stx and eae) method is based on gene amplification by the use of real-time loop-mediated isothermal amplification when used with the 3M Molecular Detection System for the rapid and specific detection of Shiga toxin gene (stx1 and/or stx2) and intimin gene (eae) from Shiga toxin-producing enterohemorrhagic Escherichia coli (STEC) in enriched foods. OBJECTIVE: The 3M Molecular Detection Assay 2 - STEC Gene Screen (stx and eae) method was evaluated as a Level 2 method modification to add new matrixes to the certified claim: 25 g fresh raw ground beef (approximately 75% lean), 375 g fresh raw ground pork (approximately 70% lean), 375 g fresh raw poultry parts, and 25 g sprouts. METHODS: Matrix studies were conducted to assess the method's performance compared to the U. S. Department of Agriculture Food Safety and Inspection Service Microbiology Laboratory Guidebook, 5C.00 for meat and poultry, and to the U. S. Food and Drug Administration Bacteriological Analytical Manual, Ch. 4A for sprouts, using an unpaired study design. RESULTS: The 3M Molecular Detection Assay 2 - STEC Gene Screen (stx and eae) method demonstrated no significant differences between presumptive and confirmed results or between candidate and reference method results for any of the matrixes tested. CONCLUSION AND HIGHLIGHTS: The data collected in these studies demonstrate that the 3M Molecular Detection Assay 2 - STEC Gene Screen (stx and eae) is a reliable method for the rapid and specific detection of STEC in fresh raw ground beef (approximately 75% lean), fresh raw ground pork (approximately 70% lean), fresh raw poultry parts, and sprouts.

Validation of the 3M™ Environmental Scrub Sampler with Wide-Spectrum Neutralizer: AOAC Performance Tested MethodSM 022104.

BACKGROUND: The 3M™ Environmental Scrub Sampler with 10 mL Wide Spectrum Neutralizer is a nonspecific sampling device intended for use for environmental monitoring surface sampling. OBJECTIVE: The aim was to evaluate 3M Wide Spectrum Neutralizer using the 3M Environmental Scrub Sampler for AOAC® Performance Tested MethodsSM (PTM) certification. METHODS: Matrix studies, inclusivity/exclusivity, product consistency/stability, neutralization, and robustness testing were conducted for Salmonella and Listeria species. Stainless steel, sealed concrete, and plastic environmental surfaces were evaluated in the matrix study comparing the performance of the 3M™ method for sample collection to that of the U.S. Food and Drug Administration (FDA) Bacteriological Analytical Manual (BAM) reference methods. Four classes of sanitizers, namely quaternary ammonium, high acid, hydrogen/peroxyacetic acid and chlorine/bleach-based, were assessed in the neutralization study following ASTM E1054 - 08, Standard Test Methods for Evaluation of Inactivators of Antimicrobial Agents. The other testing parameters followed typical PTM study design. RESULTS: In matrix studies the 3M sampling device demonstrated no significant differences between candidate and reference sampling method results. All inclusivity organisms were detected, and all exclusivity organisms were excluded, for both Salmonella and Listeria strains when tested by the appropriate FDA BAM detection method. Robustness, product consistency, and stability studies showed that the sampling device is not affected by lot or testing parameter differences. The Wide Spectrum Neutralizer was proven to effectively neutralize sanitizers at the concentrations tested and was itself shown to be nontoxic and did not affect target microorganism recovery. CONCLUSIONS: The 3M Environmental Scrub Sampler with 10 mL Wide Spectrum Neutralizer is an effective, stable, robust sampling device for the recovery of Salmonella spp. and Listeria spp. HIGHLIGHT: The 3M Environmental Scrub Sampler with 10 mL Wide Spectrum Neutralizer is an acceptable sampling device for use in FDA BAM Salmonella and Listeria reference methods.

Validation of the 3M™ Molecular Detection Assay 2 - STEC Gene Screen (stx and eae) for the Detection of Shiga Toxin Gene (stx and eae) in Fresh Raw Beef Trim, Fresh Raw Ground Beef and Fresh Spinach: AOAC Performance Tested MethodSM 071902.

BACKGROUND: The 3M™ Molecular Detection Assay 2 - STEC Gene Screen (stx and eae) method is based on gene amplification using real time loop-mediated isothermal amplification with the 3M Molecular Detection System for the rapid and specific detection of Shiga toxin gene (stx1 and/or stx2) and intimin gene (eae) from Shiga toxin-producing enterohemorrhagic Escherichia coli (STEC) in enriched foods. OBJECTIVE: The 3M Molecular Detection Assay 2 - STEC Gene Screen (stx and eae) method was evaluated for AOAC®  Performance Tested MethodsSM certification. METHODS: Matrix studies, inclusivity/exclusivity, robustness, product stability, and lot-to-lot variability testing were conducted to assess the method's performance. RESULTS: The 3M Molecular Detection Assay 2 - STEC Gene Screen (stx and eae) demonstrated equivalent results to the US Department of Agriculture-Food Safety and Inspection Service Microbiology Laboratory Guidebook 5C.00 for fresh raw beef trim and fresh raw ground beef, and to the US Food and Drug Administration Bacteriological Analytical Manual Chapter 4A for fresh spinach. The 3M Molecular Detection Assay 2 - STEC Gene Screen (stx and eae) detected 50 of 50 E. coli strains with stx1 and/or stx2 genes, and the eae gene, and detected zero of 40 strains from the exclusivity panel. Robustness testing indicated that small variations in critical test parameters did not adversely affect the assay's performance. Product consistency and stability testing demonstrated no differences between the lots evaluated. CONCLUSION: The data collected demonstrates that the 3M Molecular Detection Assay 2 - STEC Gene Screen (stx and eae) is a reliable method for the rapid and specific detection of STEC in raw beef trim, raw ground beef, and spinach. HIGHLIGHTS: The 3M Molecular Detection Assay 2 - STEC Gene Screen (stx and eae) method is suitable for the rapid and specific detection of STECs in raw beef trim, raw ground beef, and spinach.

Validation of the 3M™ Molecular Detection Assay 2 - STEC Gene Screen (stx) for the Detection of Shiga Toxin Gene (stx1 and/or stx2) in Fresh Raw Ground Beef and Fresh Spinach: AOAC Performance Tested MethodSM 071903.

BACKGROUND: The 3M™ Molecular Detection Assay 2 - STEC Gene Screen (stx) method is based on gene amplification by the use of real time loop-mediated isothermal amplification when used with the 3M Molecular Detection System for the rapid and specific detection of Shiga toxin gene (stx1 and/or stx2) from Shiga toxin-producing Escherichia coli (STEC) in enriched foods. The stx assay does not differentiate between stx1 and stx2 but detects the presence of stx1 and/or stx2. OBJECTIVE: The 3M Molecular Detection Assay 2 - STEC Gene Screen (stx) method was evaluated for AOAC®  Performance Tested MethodsSM certification. METHODS: Matrix studies, inclusivity/exclusivity, robustness testing, product stability, and lot-to-lot variability testing were conducted to assess the method's performance. RESULTS: The 3M Molecular Detection Assay 2 - STEC Gene Screen (stx) demonstrated equivalent results to the United States Department of Agriculture/Food Safety and Inspection Service Microbiology Laboratory Guidebook Chapter 5C.00 reference method for fresh raw ground beef, and the U.S. Food and Drug Administration Bacteriological Analytical Manual Chapter 4A reference method for fresh spinach. The 3M Molecular Detection Assay 2 - STEC Gene Screen (stx) detected all STEC E. coli strains (E. coli strains with stx1 and/or stx2 genes) and did not detect any of the 45 strains from the exclusivity panel. Robustness testing indicated that small variations in critical test parameters did not adversely affect the assay's performance. Product consistency and stability testing demonstrated no differences between the lots evaluated. CONCLUSION: The data collected in these studies demonstrate that the 3M Molecular Detection Assay 2 - STEC Gene Screen (stx) is a reliable method for the rapid and specific detection of Shiga toxin-producing E. coli in raw ground beef and spinach. HIGHLIGHTS: The 3M Molecular Detection Assay 2 - STEC Gene Screen (stx) method is suitable for the rapid and specific detection of Shiga toxin-producing E. coli in fresh raw ground beef, and spinach.