title: Evaluation of the Thermo Scientific SureTect Listeria monocytogenes Assay.
abstract: The Thermo Scientific SureTect Listeria monocytogenes Assay is a new real-time PCR assay for the detection of Listeria monocytogenes in food and environmental samples. This assay was validated using the AOAC Research Institute (AOAC-RI) Performance Tested Methods program in comparison to the reference method detailed in International Organization for Standardization 11290-1:1996, including Amendment 1:2004 with the following foods and food contact surfaces: smoked salmon, processed cheese, fresh bagged spinach, fresh cantaloupe, cooked prawns (chilled product), cooked sliced turkey meat (chilled product), ice cream, pork frankfurters, salami, ground raw beef meat (12% fat), plastic, and stainless steel. All matrixes were tested by Thermo Fisher Scientific, Microbiology Division, Basingstoke, UK. In addition, three matrixes (pork frankfurters, bagged lettuce, and stainless steel) were analyzed independently as part of the AOAC-RI controlled laboratory study by the University of Guelph, Canada. Using probability of detection (POD) statistical analysis, a significant difference was demonstrated between the candidate and reference methods for salami, cooked sliced turkey and ice cream in favor of the SureTect assay. For all other matrixes, no significant difference by POD was seen between the two methods during the study. Inclusivity and exclusivity testing was also conducted with 53 and 30 isolates, respectively, which demonstrated that the SureTect assay was able to detect all serotypes of L. monocytogenes. None of the exclusivity isolates analyzed were detected by the SureTect assay. Ruggedness testing was conducted to evaluate the performance of the assay with specific method deviations outside the recommended parameters open to variation, i.e., enrichment time and temperature and lysis temperature, which demonstrated that the assay gave reliable performance. Accelerated stability testing was also conducted, validating the assay shelf life.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Cloke
authors.forename: Carlos
authors.initials: C
authors.lastname: Leon-Velarde
authors.forename: Nathan
authors.initials: N
authors.lastname: Larson
authors.forename: Keron
authors.initials: K
authors.lastname: Dave
authors.forename: Katharine
authors.initials: K
authors.lastname: Evans
authors.forename: David
authors.initials: D
authors.lastname: Crabtree
authors.forename: Annette
authors.initials: A
authors.lastname: Hughes
authors.forename: Craig
authors.initials: C
authors.lastname: Hopper
authors.forename: Helen
authors.initials: H
authors.lastname: Simpson
authors.forename: Sophie
authors.initials: S
authors.lastname: Withey
authors.forename: Milena
authors.initials: M
authors.lastname: Oleksiuk
authors.forename: Jani
authors.initials: J
authors.lastname: Holopainen
authors.forename: Nina
authors.initials: N
authors.lastname: Wickstrand
authors.forename: Mikko
authors.initials: M
authors.lastname: Kauppinen
mesh_terms: D000818:Animals; D001431:Bacteriological Techniques / Q000295:instrumentation / Q000379:methods*; D028463:Cucumis melo / Q000382:microbiology; D003611:Dairy Products / Q000382:microbiology; D004783:Environmental Microbiology; D005516:Food Microbiology; D008089:Listeria monocytogenes / Q000302:isolation & purification*; D008460:Meat / Q000382:microbiology; D010969:Plastics; D016133:Polymerase Chain Reaction / Q000379:methods*; D018724:Spinacia oleracea / Q000382:microbiology; D013193:Stainless Steel
chemical_list: D010969:Plastics; D013193:Stainless Steel