An Inclusivity and Exclusivity Evaluation of the Invisible Sentinel Veriflow Salmonella Species Method for the Detection of Salmonella species

Transcription

1 An Inclusivity and Exclusivity Evaluation of the Invisible Sentinel Veriflow Salmonella Species for the Detection of Salmonella species AOAC PTM Evaluation September 20, 2013 Erin S. Crowley, Patrick M. Bird, Jonathan Flannery, Ben Bastin, M. Joseph Benzinger Jr., Will Judd, James R. Agin, David G. Goins Q Laboratories, Inc., 1400 Harrison Ave, Cincinnati, OH An inclusivity and exclusivity evaluation of the Invisible Sentinel Veriflow Salmonella Species (SS) (Philadelphia, PA) for the detection of Salmonella spp. was conducted at Q Laboratories, Inc., Cincinnati, Ohio. The was evaluated for its ability to correctly identify a variety of Salmonella strains and discriminate them from closely related non-target organisms. For this evaluation, 104 different Salmonella spp. and 35 closely related non-target isolates were analyzed by the method. The method correctly identified all 104 of the Salmonella isolates analyzed and correctly excluded all 35 non-target organisms. The method demonstrated reliability as a rapid and sensitive method for the identification of Salmonella spp. This report presents the analytical results for the inclusivity and exclusivity evaluation of the Invisible Sentinel Veriflow Salmonella Species (SS) method. All analyses were conducted at Q Laboratories, Inc. (Cincinnati, OH). All test materials and test kits unique to the method were provided by Invisible Sentinel (Philadelphia, PA). Results For the evaluation of the 104 Salmonella inclusivity strains, the method accurately identified all 104 target isolates. For the evaluation of the 35 closely related nontarget isolates, the method correctly excluded all 35 isolates. Detailed results of the inclusivity and exclusivity evaluation are presented in Tables 1 and 2 of the Appendix. Discussion The results of the inclusivity and exclusivity evaluation demonstrated the ability of the method to accurately identify and discriminate a variety of different Salmonella species from other closely related organisms. The correctly identified all strains analyzed indicating its robustness in detecting a wide range of Salmonella species, including representative isolates from all 6 subspecies.

2 Table 1: Veriflow Salmonella Species (SS) Inclusivity Summary of Results Salmonella bongori 1 NCTC Salmonella bongori 2 ATCC Salmonella bongori 1 Serotype Brookfield NCTC Salmonella enterica subsp salamae serovar Artis ATCC arizonae 2 ATCC arizonae 2 ATCC BAA-1577 arizonae 3 QL enterica serovar Abaetetuba 2 ATCC salamae 3 QL02415 salamae serovar Basel 2 ATCC enterica serovar Abortusequi 4 FDA 9842 enterica serovar Abortusovis 1 NCTC enterica serovar Abony 1 NCTC 6017 enterica serovar Adelaide 5 STS 2 amphibian; frog Veterinary isolate creek water, Zaiman, Argentina enterica serovar Agona 2 ATCC enterica serovar Agama 5 STS 3 enterica serovar Agoueve 5 STS 5 enterica serovar Alachua 5 STS 6 enterica serovar Albany 5 STS 7 enterica serovar Anatum 2 ATCC 9270 enterica serovar Arkansas 5 STS 11 diarizonae 2 ATCC BAA-1579 diarizonae 2 BAA-216 diarizonae 6 BEI NR-516 enterica serovar Bareilly H enterica serovar Berta 5 STS 13 enterica serovar Binza 5 STS 14 enterica serovar Bovis- Morbificans 5 STS 16 Pork liver, Chicago, IL blood - human (human blood) enterica serovar Brandenburg 5 STS 18 enterica serovar Bredeney 1 NCTC 5731 enterica serovar California 1 NCTC 6018 enterica serovar Cerro 5 STS 27 enterica serovar Choleraesuis 2 ATCC enterica serovar Choleraesuis var Kuzendorf 2 ATCC enterica serovar Cubana 5 STS 24 enterica serovar Derby 1 NCTC 5721 enterica serovar Drypool 5 STS 26 enterica serovar Dublin 5 STS 27 enterica serovar Eastbourne H enterica serovar Enteritidis 2 ATCC enterica serovar Galiema 3 QL024.2 enterica serovar Give 5 STS 42 Page 2 of 5

3 Table 1 (cont d): Veriflow Salmonella Species (SS) Inclusivity Summary of Results enterica serovar Haardt 5 STS 44 enterica serovar Hadar 2 ATCC enterica serovar Havana 5 STS 47 enterica serovar Heidelberg 2 ATCC 8326 enterica serovar Illinois 2 ATCC enterica serovar Indiana 1 NCTC S enterica serovar Infantis 2 ATCC enterica serovar Javiana 2 ATCC enterica serovar Jerusalem 3 QL enterica serovar Johannesburg 5 STS 56 enterica serovar Kahla 2 ATCC enterica serovar Kaitaan 3 QL024.7 enterica serovar Kentucky 2 ATCC 9263 enterica serovar Krefeld 5 STS 58 Bird; turkey Pasta Feces indica 2 ATCC BAA-1578 indica serovar Ferlac 2 ATCC indica serovar Ferlac 1 NCTC enterica serovar Lille 5 STS 59 enterica serovar Livingstone 5 STS 63 enterica serovar London 5 STS 64 enterica serovar Manhattan 5 STS 65 enterica serovar Mbandaka 4 37N enterica serovar Menden 2 ATCC enterica serovar Meleagridis 3 QL enterica serovar Menhaden 3 QL enterica serovar Montevideo 2 ATCC 8387 enterica serovar Muenchen 2 ATCC BAA-1594 enterica serovar Neasden 3 QL024.4 India Ceylonese desiccated coconut Feces stool; linked to fresh Roma tomatoes enterica serovar Newington 3 QL024.8 enterica serovar Newport 2 ATCC 6962 enterica serovar Ohio STS 81 enterica serovar Oranienburg 2 ATCC 9239 enterica serovar Orthmarshen 3 QL enterica serovar Paratyphi A 2 ATCC 9150 enterica serovar Paratyphi B 2 ATCC enterica serovar Paratyphi C 2 ATCC enterica serovar Pomona 2 ATCC enterica serovar Poona 1 NCTC 4840 enterica serovar Preston 3 QL enterica serovar Pullorum 2 ATCC enterica serovar Rubislaw 5 STS 92 enterica serovar Saintpaul 2 ATCC 9712 food poisoning fatality, England infant enteritis Egg Cystitis, Panama Page 3 of 5

4 Table 1 (cont d): Veriflow Salmonella Species (SS) Inclusivity Summary of Results enterica serovar San Diego 5 STS 94 enterica serovar Schalkwijk 3 QL enterica serovar Schwarzengrund 5 STS 95 enterica serovar Senftenberg 2 ATCC enterica serovar Stanley 2 ATCC 7308 enterica serovar Tallahassee 2 ATCC S enterica serovar Tennessee 3 QL024.6 enterica serovar Thompson H enterica serovar Typhi 2 ATCC 6539 enterica serovar Typhimurium 2 ATCC enterica serovar Utrect 1 NCTC enterica serovar Vellore 2 ATCC enterica serovar Virchow 2 ATCC enterica serovar Volta 3 QL024.9 tissue, animal Rectal Swab enterica serovar Westhampton 3 QL enterica serovar Worthington 5 STS 114 houtenae serovar Halmstead 3 QL024.1 houtenae serovar Harmelen 2 ATCC houtenae serovar Ochsenzoll 2 ATCC enterica serovar Urbana 5 STS 110 Boa constrictor, the Netherlands Page 4 of 5

5 Table 2: Veriflow Salmonella Species (SS) Exclusivity Summary of Results Alcaligenes faecalis 1 ATCC 8750 Bacillus cereus 1 ATCC Enterococcus faecium 1 ATCC Enterococcus faecalis 1 ATCC Urine Kocuria rhizophila 1 ATCC 9341 Morganella morganii 1 ATCC Soil Bacillus subtilis 1 ATCC 6051 Campylobacter lari 1 ATCC BAA-1060 Campylobacter jejuni 1 ATCC Candida albicans 1 ATCC Bovine Nail Infection Escherichia coli 1 ATCC Escherichia coli 2 BEI NR 4356 Escherichia coli 2 BEI NR-12 Hafnia alvei 1 ATCC Milk, Minnesota Proteus mirabilis 1 ATCC 7002 Proteus vulgaris 1 ATCC 6380 Pseudomonas aeruginosa 1 ATCC Shigella sonnei 1 ATCC Urine Carnobacterium maltaromaticum 1 ATCC Citrobacter farmeri 1 ATCC Citrobacter freundii 1 ATCC 8090 Edwardsiella tarda 1 ATCC Enterobacter aerogenes 1 ATCC Enterobacter cloacea 1 ATCC Vacuumpacked beef Sputum Lactobacillus acidophilus 1 ATCC 314 Lactobacillus kefiri 1 ATCC Lactobacillus lactis 1 ATCC 4794 Listeria monocytogenes 1 ATCC 7644 Listeria innocua 1 ATCC Klebsiella pneumonia 1 ATCC ATCC- American Type Culture Collection; 2 Invisible Sentinel Culture Collection Kefir Cow Brain aureus 1 ATCC epidermidis 1 ATCC haemolyticus 1 ATCC hominis 1 ATCC Streptococcus pneumoniae 1 ATCC 6302 Skin Skin Page 5 of 5