Evaluation of the Thermo Scientific™ SureTect™ Listeria species Assay
The Thermo Scientific™ SureTect™ Listeria species Assay is a new real-time PCR assay for the detection of all species of Listeria in food and environmental samples. This validation study was conducted using the AOAC Research Institute (RI) Performance Tested MethodsSM program to validate the SureTec...
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| Veröffentlicht in: | Journal of AOAC International 2014-03, Vol.97 (2), p.521-538 |
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| creator | Cloke, Jonathan Evans, Katharine Crabtree, David Hughes, Annette Simpson, Helen Holopainen, Jani Wickstrand, Nina Kauppinen, Mikko |
| description | The Thermo Scientific™ SureTect™ Listeria species Assay is a new real-time PCR assay for the detection of all species of Listeria in food and environmental samples. This validation study was conducted using the AOAC Research Institute (RI) Performance Tested MethodsSM program to validate the SureTect Listeria species Assay in comparison to the reference method detailed in International Organization for Standardization 11290-1:1996 including amendment 1:2004 in a variety of foods plus plastic and stainless steel. The food matrixes validated were smoked salmon, processed cheese, fresh bagged spinach, cantaloupe, cooked prawns, cooked sliced turkey meat, cooked sliced ham, salami, pork frankfurters, and raw ground beef. All matrixes were tested by Thermo Fisher Scientific, Microbiology Division, Basingstoke, UK. In addition, three matrixes (pork frankfurters, fresh bagged spinach, and stainless steel surface samples) were analyzed independently as part of the AOAC-RI-controlled independent laboratory study by the University of Guelph, Canada. Using probability of detection statistical analysis, a significant difference in favour of the SureTect assay was demonstrated between the SureTect and reference method for high level spiked samples of pork frankfurters, smoked salmon, cooked prawns, stainless steel, and low-spiked samples of salami. For all other matrixes, no significant difference was seen between the two methods during the study. Inclusivity testing was conducted with 68 different isolates of Listeria species, all of which were detected by the SureTect Listeria species Assay. None of the 33 exclusivity isolates were detected by the SureTect Listeria species Assay. Ruggedness testing was conducted to evaluate the performance of the assay with specific method deviations outside of the recommended parameters open to variation, which demonstrated that the assay gave reliable performance. Accelerated stability testing was additionally conducted, validating the assay shelf life. |
| doi_str_mv | 10.5740/jaoacint.13-317 |
| format | Article |
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This validation study was conducted using the AOAC Research Institute (RI) Performance Tested MethodsSM program to validate the SureTect Listeria species Assay in comparison to the reference method detailed in International Organization for Standardization 11290-1:1996 including amendment 1:2004 in a variety of foods plus plastic and stainless steel. The food matrixes validated were smoked salmon, processed cheese, fresh bagged spinach, cantaloupe, cooked prawns, cooked sliced turkey meat, cooked sliced ham, salami, pork frankfurters, and raw ground beef. All matrixes were tested by Thermo Fisher Scientific, Microbiology Division, Basingstoke, UK. In addition, three matrixes (pork frankfurters, fresh bagged spinach, and stainless steel surface samples) were analyzed independently as part of the AOAC-RI-controlled independent laboratory study by the University of Guelph, Canada. Using probability of detection statistical analysis, a significant difference in favour of the SureTect assay was demonstrated between the SureTect and reference method for high level spiked samples of pork frankfurters, smoked salmon, cooked prawns, stainless steel, and low-spiked samples of salami. For all other matrixes, no significant difference was seen between the two methods during the study. Inclusivity testing was conducted with 68 different isolates of Listeria species, all of which were detected by the SureTect Listeria species Assay. None of the 33 exclusivity isolates were detected by the SureTect Listeria species Assay. Ruggedness testing was conducted to evaluate the performance of the assay with specific method deviations outside of the recommended parameters open to variation, which demonstrated that the assay gave reliable performance. Accelerated stability testing was additionally conducted, validating the assay shelf life.</description><identifier>ISSN: 1060-3271</identifier><identifier>EISSN: 1944-7922</identifier><identifier>DOI: 10.5740/jaoacint.13-317</identifier><identifier>PMID: 29166998</identifier><language>eng</language><publisher>England: Oxford University Press</publisher><subject>Food contamination ; Food research ; Identification and classification ; Listeria ; Microbiological research</subject><ispartof>Journal of AOAC International, 2014-03, Vol.97 (2), p.521-538</ispartof><rights>COPYRIGHT 2014 Oxford University Press</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3207-716af9e2dde9ca29f7ef7da5a616325b1f79abe1972de3b0bc689716e90bb6d53</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29166998$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Cloke, Jonathan</creatorcontrib><creatorcontrib>Evans, Katharine</creatorcontrib><creatorcontrib>Crabtree, David</creatorcontrib><creatorcontrib>Hughes, Annette</creatorcontrib><creatorcontrib>Simpson, Helen</creatorcontrib><creatorcontrib>Holopainen, Jani</creatorcontrib><creatorcontrib>Wickstrand, Nina</creatorcontrib><creatorcontrib>Kauppinen, Mikko</creatorcontrib><title>Evaluation of the Thermo Scientific™ SureTect™ Listeria species Assay</title><title>Journal of AOAC International</title><addtitle>J AOAC Int</addtitle><description>The Thermo Scientific™ SureTect™ Listeria species Assay is a new real-time PCR assay for the detection of all species of Listeria in food and environmental samples. This validation study was conducted using the AOAC Research Institute (RI) Performance Tested MethodsSM program to validate the SureTect Listeria species Assay in comparison to the reference method detailed in International Organization for Standardization 11290-1:1996 including amendment 1:2004 in a variety of foods plus plastic and stainless steel. The food matrixes validated were smoked salmon, processed cheese, fresh bagged spinach, cantaloupe, cooked prawns, cooked sliced turkey meat, cooked sliced ham, salami, pork frankfurters, and raw ground beef. All matrixes were tested by Thermo Fisher Scientific, Microbiology Division, Basingstoke, UK. In addition, three matrixes (pork frankfurters, fresh bagged spinach, and stainless steel surface samples) were analyzed independently as part of the AOAC-RI-controlled independent laboratory study by the University of Guelph, Canada. Using probability of detection statistical analysis, a significant difference in favour of the SureTect assay was demonstrated between the SureTect and reference method for high level spiked samples of pork frankfurters, smoked salmon, cooked prawns, stainless steel, and low-spiked samples of salami. For all other matrixes, no significant difference was seen between the two methods during the study. Inclusivity testing was conducted with 68 different isolates of Listeria species, all of which were detected by the SureTect Listeria species Assay. None of the 33 exclusivity isolates were detected by the SureTect Listeria species Assay. Ruggedness testing was conducted to evaluate the performance of the assay with specific method deviations outside of the recommended parameters open to variation, which demonstrated that the assay gave reliable performance. Accelerated stability testing was additionally conducted, validating the assay shelf life.</description><subject>Food contamination</subject><subject>Food research</subject><subject>Identification and classification</subject><subject>Listeria</subject><subject>Microbiological research</subject><issn>1060-3271</issn><issn>1944-7922</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><recordid>eNptkU1LAzEQhoMoVqtnb7Lgxcu2-WiTzbGIX1Dw0HoO2ezEpuxuarIr9O4v8af5S0ypCoLMYYbheYaBF6ELgkdTMcHjtfbauLYbEZYzIg7QCZGTSS4kpYdpxhznjAoyQKcxrjGeEI7pMRpQSTiXsjhBj7dvuu5153ybeZt1K8iWKwiNzxbGQds568zn-0e26AMswXS7ee5iB8HpLG4gQTGbxai3Z-jI6jrC-Xcfoue72-XNQz5_un-8mc1zwygWuSBcWwm0qkAaTaUVYEWlp5oTzui0JFZIXQKRglbASlwaXsgkgcRlyaspG6Lr_d1N8K89xE41Lhqoa92C76MikouC46LACb3aoy-6BuVa67ugzQ5XM8aFkJJQmqjRP1SqChpnfAvWpf0fYbwXTPAxBrBqE1yjw1YRrHaxqJ9YFGEqxZKMy--f-7KB6pf_yYF9AUiXiyI</recordid><startdate>20140301</startdate><enddate>20140301</enddate><creator>Cloke, Jonathan</creator><creator>Evans, Katharine</creator><creator>Crabtree, David</creator><creator>Hughes, Annette</creator><creator>Simpson, Helen</creator><creator>Holopainen, Jani</creator><creator>Wickstrand, Nina</creator><creator>Kauppinen, Mikko</creator><general>Oxford University Press</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20140301</creationdate><title>Evaluation of the Thermo Scientific™ SureTect™ Listeria species Assay</title><author>Cloke, Jonathan ; Evans, Katharine ; Crabtree, David ; Hughes, Annette ; Simpson, Helen ; Holopainen, Jani ; Wickstrand, Nina ; Kauppinen, Mikko</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3207-716af9e2dde9ca29f7ef7da5a616325b1f79abe1972de3b0bc689716e90bb6d53</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Food contamination</topic><topic>Food research</topic><topic>Identification and classification</topic><topic>Listeria</topic><topic>Microbiological research</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Cloke, Jonathan</creatorcontrib><creatorcontrib>Evans, Katharine</creatorcontrib><creatorcontrib>Crabtree, David</creatorcontrib><creatorcontrib>Hughes, Annette</creatorcontrib><creatorcontrib>Simpson, Helen</creatorcontrib><creatorcontrib>Holopainen, Jani</creatorcontrib><creatorcontrib>Wickstrand, Nina</creatorcontrib><creatorcontrib>Kauppinen, Mikko</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of AOAC International</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Cloke, Jonathan</au><au>Evans, Katharine</au><au>Crabtree, David</au><au>Hughes, Annette</au><au>Simpson, Helen</au><au>Holopainen, Jani</au><au>Wickstrand, Nina</au><au>Kauppinen, Mikko</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Evaluation of the Thermo Scientific™ SureTect™ Listeria species Assay</atitle><jtitle>Journal of AOAC International</jtitle><addtitle>J AOAC Int</addtitle><date>2014-03-01</date><risdate>2014</risdate><volume>97</volume><issue>2</issue><spage>521</spage><epage>538</epage><pages>521-538</pages><issn>1060-3271</issn><eissn>1944-7922</eissn><abstract>The Thermo Scientific™ SureTect™ Listeria species Assay is a new real-time PCR assay for the detection of all species of Listeria in food and environmental samples. 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Using probability of detection statistical analysis, a significant difference in favour of the SureTect assay was demonstrated between the SureTect and reference method for high level spiked samples of pork frankfurters, smoked salmon, cooked prawns, stainless steel, and low-spiked samples of salami. For all other matrixes, no significant difference was seen between the two methods during the study. Inclusivity testing was conducted with 68 different isolates of Listeria species, all of which were detected by the SureTect Listeria species Assay. None of the 33 exclusivity isolates were detected by the SureTect Listeria species Assay. Ruggedness testing was conducted to evaluate the performance of the assay with specific method deviations outside of the recommended parameters open to variation, which demonstrated that the assay gave reliable performance. 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| ispartof | Journal of AOAC International, 2014-03, Vol.97 (2), p.521-538 |
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| source | Oxford University Press Journals All Titles (1996-Current) |
| subjects | Food contamination Food research Identification and classification Listeria Microbiological research |
| title | Evaluation of the Thermo Scientific™ SureTect™ Listeria species Assay |
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