Project Title Multiplex Screening Panel for the Detection of Toxins (Clostridium botulinum Toxin Genes; Staphylococcal Enterotoxin genes) in Food: Liquid MicroArray xTAG Technology Abstract Food borne disease outbreaks and food borne illnesses place a significant load on the health care system in the United States each year. While the number of food borne disease outbreaks (FBDO) reported to the CDC in 2008 have decreased from 1,270 (2006) to 1,034 (2008), the number of hospitalizations have increased where 23,152 became ill and there were 22 reported deaths. (1) Due to its self-limiting nature, Staphyloccocal food-intoxication goes mostly unreported. While it is rarely life-threatening, traditionally vulnerable populations, such as young children and the elderly, are disproportionately affected with a 4.4% mortality rate (2). However, it is the incapacitating effects of inhalational exposure to serotype B (Staphylococcal Enterotoxin B-SEB), a Category B select agent, that is of utmost concern. The development of a rapid molecular tool to screen for botulinum neurotoxin genes A and B ( bot A, bot B) for diagnostic purposes and surveillance may provide a better understanding of the epidemiology of the disease;it may be used as a predictor for the presence of the functional toxins in the food that may lead to successful treatment, reduce the number of hospitalizations and reduce the risk of deaths from botulism. Additionally, the faster an agent and source can be traced, the higher the public's confidence and trust in those agencies responsible for keeping our food safe. More importantly, it will benefit food surveillance and outbreak investigations not only in Hawaii but also to provide support for the US Affiliated Pacific Islands.

Public Health Relevance

Project Title Multiplex Screening Panel for the Detection of Clostridium botulinum Toxin Genes and Staphylococcal Enterotoxin genes in Food: Liquid MicroArray Direct Oligo Technology Introduction Food borne disease outbreaks and food borne illnesses place a significant burden on the health care system in the United States each year. While the number of food borne disease outbreaks (FBDO) reported to the CDC in 2008 have decreased from 1,270 (2006) to 1,034 (2008), the number of hospitalizations have increased where 23,152 reported ill and 22 deaths. (1) In this report, among laboratory-confirmed cases caused by bacteria and bacterial toxins, Staphylococcal Enterotoxins (SET) and Clostridium botulinum ranked 4th and 5th( with 12/1091 and 9/1091 hospitalizations, respectively) following Salmonella ( 797/1091), Shiga-toxin producing E. coli (214/1091) and Campylobacter (25/1091). (1) Staphylococcus aureus has become synonymous with nosocomial infections and a multitude of methods have been devised to detect and categorize this pathogen in that context;often over looked is that S. aureus is also estimated to account for 14% of food-borne illness (2) in the United States. A CDC report indicated that thirty one (31) pathogens account for most food-borne related illness in the USA and Staphylococcus aureus is one of the top five pathogens in the list, with an estimated reported cases of 241,148 in 2011. Due to its self-limiting nature, Staphyloccocal food-intoxication goes mostly unreported. While it is rarely life-threatening, traditionally vulnerable populations, such as young children and the elderly, are disproportionately affected with a 4.4% mortality rate (2). However, it is the incapacitating effects of inhalational exposure to serotype B (Staphylococcal Enterotoxin B-SEB), a Category B select agent, that is of utmost concern. Results of the study will benefit food surveillance and outbreak investigations not only in Hawaii but also support the US Affiliated Pacific Islands in the event of a natural or intentional contamination of food. Clostridium botulinum is gram positive, spore-forming anaerobic bacteria that produces a very potent neurotoxin that may cause botulism in humans and animals. Botulism is hard to diagnose and may often be misdiagnosed in the absence of epidemiologically-linked cases. Toxin producing strains of C. botulinum produce seven toxin types ( A-G). In 2010, according to the Summary of Botulism cases reported at the CDC, foodborne botulism accounted for 8% (9/112) of the total cases of which 33% (3/9) were attributed to Type A toxin, 33% to Type B and Type E toxin accounted for 22% (2/9) of the cases. Toxin detection is confirmed using the standard mouse bioassay (SMB) which is time-consuming and expensive to maintain. (3) The development of a rapid molecular tool to screen for botulinum neurotoxin genes A and B ( bot A, bot B) for diagnostic purposes and surveillance may provide a better understanding of the epidemiology of the disease;it may be used as a predictor for the presence of the functional toxins in the food that may lead to successful treatment, reduce the number of hospitalizations and reduce the risk of deaths from botulism.

Agency
National Institute of Health (NIH)
Institute
Food and Drug Administration (FDA)
Type
Research Demonstration--Cooperative Agreements (U18)
Project #
5U18FD003811-06
Application #
8719747
Study Section
Special Emphasis Panel (ZFD1)
Project Start
2009-09-18
Project End
2015-08-31
Budget Start
2014-09-01
Budget End
2015-08-31
Support Year
6
Fiscal Year
2014
Total Cost
Indirect Cost
Name
Hawaii State Department of Health
Department
Type
DUNS #
City
Honolulu
State
HI
Country
United States
Zip Code
96813