title: Samsung Salmonella Detection Kit. AOAC Performance Tested Method(SM) 021203.
abstract: Salmonella, one of the most common causes of foodborne illness, is a significant public health concern worldwide. There is a need in the food industry for methods that are simple, rapid, and sensitive for the detection of foodborne pathogens. In this study, the Samsung Salmonella Detection Kit, a real-time PCR assay for the detection of Salmonella, was evaluated according to the current AOAC guidelines. The validation consisted of lot-to-lot consistency, stability, robustness, and inclusivity/exclusivity studies, as well as a method comparison of 10 different food matrixes. In the validation, the Samsung Salmonella Detection Kit was used in conjunction with the Applied Biosystems StepOnePlus PCR system and the Samsung Food Testing Software for the detection of Salmonella species. The performance of the assays was compared to the U.S. Department of Agriculture/Food Safety and Inspection Service-Microbiology Laboratory Guidebook (USDA/FSIS-MLG) 4.05: Isolation and Identification of Salmonella from Meat, Poultry, Pasteurized Egg, and Catfish and the and U.S. Food and Drug Administration/Bacteriological Analytical Manual (FDA/BAM) Chapter 5 Salmonella reference methods. The validation was conducted using an unpaired study design for detection of Salmonella spp. in raw ground beef, raw pork, raw ground pork, raw chicken wings, raw salmon, alfalfa sprouts, pasteurized orange juice, peanut butter, pasteurized whole milk, and shell eggs. The Samsung Salmonella Detection Kit demonstrated lot-to-lot consistency among three independent lots as well as ruggedness with minor modifications to changes in enrichment incubation time, enrichment incubation temperature, and DNA sample volume for PCR reaction. Stability was observed for 13 months at -20 degrees C and 3 months at 5 degrees C. For the inclusivity/exclusivity study, the Samsung Salmonella Detection Kit correctly identified 147 Salmonella species isolates out of 147 isolates tested from each of three different enrichment broths (a total of 441 isolates detected), and correctly excluded all 31 nontarget strains analyzed. For the method comparison, statistical analysis was conducted according to the Mantel-Haenszel Chi-square formula for unpaired test portions, and there was no significant difference in the number of positive samples detected between the Samsung Salmonella Detection Kit and the USDA/FSIS-MLG and FDA/BAM reference methods for all 10 food matrixes.
authors: Samsung Techwin Co., Ltd, Biotechnology Division, 6636 Virginia Manor Rd, Beltsville, MD 20705, USA. jun36.li@samsung.com
authors: Jun
authors: J
authors: Li
authors: Win Den
authors: WD
authors: Cheung
authors: Jason
authors: J
authors: Opdyke
authors: John
authors: J
authors: Harvey
authors: Songchun
authors: S
authors: Chong
authors: Cheol Gon
authors: CG
authors: Moon
mesh_terms: D000818:Animals; D010367:Arachis / Q000382:microbiology; D001628:Beverages / Q000382:microbiology; D002417:Cattle; D002645:Chickens; D003627:Data Interpretation, Statistical; D004531:Eggs / Q000382:microbiology; D005506:Food Contamination / Q000032:analysis*; D005516:Food Microbiology / Q000295:instrumentation* / Q000379:methods*; D005638:Fruit / Q000382:microbiology; D007202:Indicators and Reagents; D008460:Meat / Q000382:microbiology; D000455:Medicago sativa / Q000737:chemistry / Q000382:microbiology; D008892:Milk / Q000382:microbiology; D061352:Pasteurization; D011933:Reagent Kits, Diagnostic; D060888:Real-Time Polymerase Chain Reaction; D012015:Reference Standards; D015203:Reproducibility of Results; D012474:Salmon; D012475:Salmonella / Q000737:chemistry*; D013552:Swine
chemical_list: D007202:Indicators and Reagents; D011933:Reagent Kits, Diagnostic