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Multiplex Assay for Rapid Salmonella Serotyping from Human, Animal, Food and Environmental Sources

CDC researchers have developed a bead-based nucleic acid assay for serotyping members of theSalmonellagenus; this assay will identify serotypes for approximately 95% of all human-obtainedSalmonellaisolates in the United States. Presently, production and quality control for the more than 250 antisera required to cover the >2,500 known serotypes using current methods is difficult, expensive and laborious. Many clinicalSalmonellaisolates can require three to five days to determine serotype, delaying conclusive serotype identification and postponing alerts to public health monitoring programs. To that end, this new assay provides improved diagnostic identification and discrimination as well as reducing reagent consumption and technician labor. The assay has been developed and optimized in parallel with traditional serotyping methods on a panel of 368 isolates that represents all subspecies/serogroup combinations in the current Kauffmann-WhiteSalmonellaclassification scheme, and the assay has been shown to be more specific than traditional molecular assay formats. This diagnostic assay will improve the rate and accuracy ofSalmonelladetection serotyping within human, animal, food and environmental samples.
Patent Abstract: 
CDC researchers have developed a bead-based nucleic acid assay for serotyping members of theSalmonellagenus; this assay will identify serotypes for approximately 95% of all human-obtainedSalmonellaisolates in the United States. Presently, production and quality control for the more than 250 antisera required to cover the >2,500 known serotypes using current methods is difficult, expensive and laborious. Many clinicalSalmonellaisolates can require three to five days to determine serotype, delaying conclusive serotype identification and postponing alerts to public health monitoring programs. To that end, this new assay provides improved diagnostic identification and discrimination as well as reducing reagent consumption and technician labor. The assay has been developed and optimized in parallel with traditional serotyping methods on a panel of 368 isolates that represents all subspecies/serogroup combinations in the current Kauffmann-WhiteSalmonellaclassification scheme, and the assay has been shown to be more specific than traditional molecular assay formats. This diagnostic assay will improve the rate and accuracy ofSalmonelladetection serotyping within human, animal, food and environmental samples.
Benefits 
Rapid detection and quantification ofSalmonellaserotypes from fluidic human, animal, food and environmental samples -Increased sensitivity and efficiency compared to current serotyping assays -Addresses critical need for improvement in accurate molecular diagnosis for multipleSalmonellaserotypes -Ready for commercialization, allows for easy addition/modification for future assay expansions -Easily implemented as a kit
applications 
Inventors: 
Patricia Fields
Patent Number: 
61/406,797 US Application No. 13/871,098 US Applic
Internal Laboratory Ref #: 
E-149-2013/0
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