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  1. Article: Roka Listeria detection method using transcription mediated amplification to detect Listeria species in select foods and surfaces. Performance Tested Method(SM) 011201.

    Hua, Yang / Kaplan, Shannon / Reshatoff, Michael / Hu, Ernie / Zukowski, Alexis / Schweis, Franz / Gin, Cristal / Maroni, Brett / Becker, Michael / Wisniewski, Michele

    Journal of AOAC International

    2013  Volume 95, Issue 6, Page(s) 1672–1688

    Abstract: The Roka Listeria Detection Assay was compared to the reference culture methods for nine select foods and three select surfaces. The Roka method used Half-Fraser Broth for enrichment at 35 +/- 2 degrees C for 24-28 h. Comparison of Roka's method to ... ...

    Abstract The Roka Listeria Detection Assay was compared to the reference culture methods for nine select foods and three select surfaces. The Roka method used Half-Fraser Broth for enrichment at 35 +/- 2 degrees C for 24-28 h. Comparison of Roka's method to reference methods requires an unpaired approach. Each method had a total of 545 samples inoculated with a Listeria strain. Each food and surface was inoculated with a different strain of Listeria at two different levels per method. For the dairy products (Brie cheese, whole milk, and ice cream), our method was compared to AOAC Official Method(SM) 993.12. For the ready-to-eat meats (deli chicken, cured ham, chicken salad, and hot dogs) and environmental surfaces (sealed concrete, stainless steel, and plastic), these samples were compared to the U.S. Department of Agriculture/Food Safety and Inspection Service-Microbiology Laboratory Guidebook (USDA/FSIS-MLG) method MLG 8.07. Cold-smoked salmon and romaine lettuce were compared to the U.S. Food and Drug Administration/Bacteriological Analytical Manual, Chapter 10 (FDA/BAM) method. Roka's method had 358 positives out of 545 total inoculated samples compared to 332 positive for the reference methods. Overall the probability of detection analysis of the results showed better or equivalent performance compared to the reference methods.
    MeSH term(s) Animals ; Automation ; Colony Count, Microbial ; Dairy Products/microbiology ; Food Microbiology/instrumentation ; Food Microbiology/methods ; Indicators and Reagents ; Lactuca/microbiology ; Listeria/chemistry ; Listeria/genetics ; Meat/microbiology ; Milk/microbiology ; Nucleic Acid Amplification Techniques ; Reagent Kits, Diagnostic ; Reference Standards ; Reproducibility of Results
    Chemical Substances Indicators and Reagents ; Reagent Kits, Diagnostic
    Language English
    Publishing date 2013-02-15
    Publishing country England
    Document type Journal Article ; Validation Study
    ZDB-ID 1103149-9
    ISSN 1944-7922 ; 1060-3271
    ISSN (online) 1944-7922
    ISSN 1060-3271
    DOI 10.5740/jaoacint.12-063
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Atlas(®) Listeria monocytogenes LmG2 Detection Assay Using Transcription Mediated Amplification to Detect Listeria monocytogenes in Selected Foods and Stainless Steel Surface.

    Bres, Vanessa / Yang, Hua / Hsu, Ernie / Ren, Yan / Cheng, Ying / Wisniewski, Michele / Hanhan, Maesa / Zaslavsky, Polina / Noll, Nathan / Weaver, Brett / Campbell, Paul / Reshatoff, Michael / Becker, Michael

    Journal of AOAC International

    2015  Volume 97, Issue 5, Page(s) 1343–1358

    Abstract: The Atlas Listeria monocytogenes LmG2 Detection Assay, developed by Roka Bioscience Inc., was compared to a reference culture method for seven food types (hot dogs, cured ham, deli turkey, chicken salad, vanilla ice cream, frozen chocolate cream pie, and ...

    Abstract The Atlas Listeria monocytogenes LmG2 Detection Assay, developed by Roka Bioscience Inc., was compared to a reference culture method for seven food types (hot dogs, cured ham, deli turkey, chicken salad, vanilla ice cream, frozen chocolate cream pie, and frozen cheese pizza) and one surface (stainless steel, grade 316). A 125 g portion of deli turkey was tested using a 1:4 food:media dilution ratio, and a 25 g portion for all other foods was tested using 1:9 food:media dilution ratio. The enrichment time and media for Roka's method was 24 to 28 h for 25 g food samples and environmental surfaces, and 44 to 48 h for 125 g at 35 ± 2°C in PALCAM broth containing 0.02 g/L nalidixic acid. Comparison of the Atlas Listeria monocytogenes LmG2 Detection Assay to the reference method required an unpaired approach. For each matrix, 20 samples inoculated at a fractional level and five samples inoculated at a high level with a different strain of Listeria monocytogenes were tested by each method. The Atlas Listeria monocytogenes LmG2 Detection Assay was compared to the Official Methods of Analysis of AOAC INTERNATIONAL 993.12 method for dairy products, the U.S. Department of Agriculture, Food Safety and Inspection Service, Microbiology Laboratory Guidebook 8.08 method for ready-to-eat meat and environmental samples, and the U.S. Food and Drug Administration Bacteriological Analytical Manual, Chapter 10 method for frozen foods. In the method developer studies, Roka's method, at 24 h (or 44 h for 125 g food samples), had 126 positives out of 200 total inoculated samples, compared to 102 positives for the reference methods at 48 h. In the independent laboratory studies, vanilla ice cream, deli turkey and stainless steel grade 316 were evaluated. Roka's method, at 24 h (or 44 h for 125 g food samples), had 64 positives out of 75 total inoculated samples compared to 54 positives for the reference methods at 48 h. The Atlas Listeria monocytogenes LmG2 Detection Assay detected all 50 L. monocytogenes strains that encompassed 13 serotypes across the various lineages and none of the 30 exclusive organisms, including seven other Listeria species. The product consistency and kit stability studies revealed no statistical differences between the three lots tested or to the term of the shelf life. Finally, the robustness study demonstrated no statistical differences when samples were incubated at 33 ± 2°C or 37 ± 2°C, when enrichment aliquots were 1.3 mL or 1.7 mL, or when the samples were analyzed the same day or five days later. Overall the Atlas Listeria monocytogenes LmG2 Detection Assay is statistically equivalent to or better than the reference methods and is robust to the tested variations.
    MeSH term(s) Bacteriological Techniques/methods ; Food Microbiology ; Listeria monocytogenes/genetics ; Listeria monocytogenes/isolation & purification ; Nucleic Acid Amplification Techniques/methods ; Reagent Kits, Diagnostic ; Stainless Steel
    Chemical Substances Reagent Kits, Diagnostic ; Stainless Steel (12597-68-1)
    Language English
    Publishing date 2015-04-07
    Publishing country England
    Document type Journal Article
    ZDB-ID 1103149-9
    ISSN 1944-7922 ; 1060-3271
    ISSN (online) 1944-7922
    ISSN 1060-3271
    DOI 10.5740/jaoacint.13-386
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article: Atlas Salmonella detection method using transcription mediated amplification (TMA) to detect Salmonella enterica in a variety of foods and select surfaces.

    Kwong, William / Livezey, Kristin / Reshatoff, Michael / Vaughn, Steve / Freed, Anna / Puente, Celina / Hu, Ernie / Zukowski, Alexis / Schweis, Franz / Yang, Hua / Fleischer, Chad / Kamantigue, Edgar / Morgan, Jarrod / Koehler, Robert / Maroni, Brett / Becker, Michael / Wisniewski, Michele

    Journal of AOAC International

    2013  Volume 96, Issue 4, Page(s) 822–841

    Abstract: The Atlas Salmonella detection assay was compared to the reference culture methods for 12 foods and three surfaces. Comparison of the Atlas method to the U.S. Food and Drug Administration Bacteriological Analytical Manual (FDA/BAM) and U.S. Department of ...

    Abstract The Atlas Salmonella detection assay was compared to the reference culture methods for 12 foods and three surfaces. Comparison of the Atlas method to the U.S. Food and Drug Administration Bacteriological Analytical Manual (FDA/BAM) and U.S. Department of Agriculture-Food Safety and Inspection Service/Microbiology Laboratory Guidebook (USDA-FSIS/MLG) reference methods required an unpaired approach. Each method had a total of 320 samples inoculated with an S. enterica strain. Each food and surface was inoculated with a different strain of S. enterica at two different levels/ method. Meat and egg products were compared to the USDA-FSIS/MLG 4.05 method. All other foods were compared to the FDA/BAM-5 method. The Atlas method had 148 positives out of 320 total inoculated samples, compared to 119 positives for the reference methods. Overall, the probability of detection analysis of the results showed equivalent or better performance by the Atlas Salmonella detection method compared to the reference methods. The Atlas Salmonella detection assay detected all 100 inclusive organisms and none of the 30 exclusive organisms. The lot-to-lot and kit stability studies showed no statistical differences between lots or over the term of the shelf-life. Instrument-to-instrument testing showed no statistical difference between instruments. Finally, the robustness study showed no difference when the sample volume added to the Atlas Salmonella detection assay varied by 10%, storage time was extended up to 5 days before analysis, or enrichment times were varied from 12 to 24 h.
    MeSH term(s) Food Microbiology ; Nucleic Acid Amplification Techniques/methods ; Reagent Kits, Diagnostic ; Reproducibility of Results ; Salmonella enterica/isolation & purification
    Chemical Substances Reagent Kits, Diagnostic
    Language English
    Publishing date 2013-09-03
    Publishing country England
    Document type Journal Article
    ZDB-ID 1103149-9
    ISSN 1944-7922 ; 1060-3271
    ISSN (online) 1944-7922
    ISSN 1060-3271
    DOI 10.5740/jaoacint.12-324
    Database MEDical Literature Analysis and Retrieval System OnLINE

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