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Finding Human Carriers of Taeniasis to Prevent Neurocysticercosis Associated Epilepsy Fast-Track proposals will not be accepted. Number of anticipated awards: 1 Budget (total costs): Phase I:

Description:

Fast-Track proposals will not be accepted.
Number of anticipated awards: 1
Budget (total costs):
Phase I: up to $150,000 for up to 12 months
PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED.
Background
Cysticercosis is a neglected parasitic infection targeted for priority public health action. Cysticercosis is caused by larval cysts of the tapeworm Taenia solium (T. solium) acquired by eating pork tapeworm egg-contaminated food or through accidental self-infection due to poor personal hygiene of subjects with taeniasis (the harboring of adult worm stage in the gastro-intestinal tract). When these cysts infect the brain (neurocysticercosis), they can result in seizures. Neurocysticercosis (NCC) is the leading cause of adult onset epilepsy in the developing world, accounting for about 29% of epilepsy cases in endemic areas (Nash 2014). In areas with large U.S. immigrant populations, up to 10% of emergency room seizure patients had NCC (Ong et al., 2012). NCC is reportable in 6 U.S. southwest border states. NCC related hospital costs in California exceeded $17 million (Croker et al., 2012). Globally, human cysticercosis poses the highest burden for disability-adjusted life years (DALYs) associated with food-borne infection (Torgerson et al., 2015). A fecal–oral-transmitted disease, cysticercosis can be spread by people directly or indirectly through food contamination. Infected persons often are unaware of their infection or of the potential risks regarding transmission (Sorvillo et al., 2011).
As humans are the only reservoir of T. solium, finding subjects with taeniasis is critical to control and eliminate T. solium related diseases. Current laboratory tools to detect infected cases are inadequate. Developing a valid point-of-care (bedside medical diagnostic) test for taeniasis coproantigen can support efforts to control and eliminate T. solium. This test could be used to screen subjects at high risk for taeniasis, potentially preventing spread of infection by food handlers, within households, and among other community members, thereby reducing epilepsy burden.
Currently, finding taeniasis carriers relies on either microscopy, by polymerase chain reaction (PCR), and/or detection of taeniasis coproantigen in the stool in the enzyme-linked immunosorbent assay (ELISA) platform. Microscopy is not sensitive and cannot differentiate between T. saginata and T. solium. PCR for detection of T. solium performs well but cannot be used in the field or for monitoring effects of treatment of subjects with taeniasis. The Taeniasis coproantigen ELISA-based platform detects current, active case of taeniasis and could quantify the amount of antigens in the stool.
Unfortunately, the current ELISA-based platform also cannot be used in the field and more importantly, uses polyclonal antibodies against T. saginata which makes it not species-specific and increases batch-to-batch variation. Public health officials need a better test reagent that is species-specific and avoids batch-to-batch variation.
By developing a taeniasis coproantigen assay, we could screen subjects at high risk for taeniasis, especially food handlers, to improve US food safety and to prevent neurocysticercosis in the US population. Globally, the availability of a point-of-care test for taeniasis coproantigen would support the effort to control and eliminate
T. solium.

Project Goals
To develop a human taeniasis coproantigen detection assay using capture reagents that are species-specific and heat-stable and have minimal batch-to-batch variation.
Phase I Activities and Expected Deliverables
1.
Find monoclonal antibodies/aptamers that will bind to T. solium adult worm extracts but not to Phosphate buffered saline or normal stool samples
2.
Submit to CDC 5 monoclonal antibody clones or 5 aptamers (sequences and aptamer products) that bind with high affinity to T. solium adult worm extracts but NOT to normal stool samples
3.
Submit to CDC a detailed report of the strategy and the analysis of the monoclonal antibodies or aptamers which include the sequences of the 5 aptamers selected
For Successful Phase I Awardees ONLY (Expected Phase II Deliverables)
1.
Develop an ELISA using those monoclonal antibodies or aptamers with the expected deliverable: an ELISA kit with monoclonal antibodies or aptamers that could differentiate human taeniasis positive stool samples from negative samples with a sensitivity of 95% and a specificity of 95%.
2.
Develop a dipstick test to determine if a stool sample is positive or not with the expected deliverable: A dipstick assay with a quantitative results based on fluorescence that could be read by a mobile phone reader.
3.
Conduct heat stability study for the all developed assays with the expected deliverable: a test with self-life of1 year at 4 C.
Impact
Availability of a species-specific taeniasis coproantigen ELISA assay will improve the service of the CDC Reference Diagnostic Laboratory in helping states and clinicians to detect, treat, and monitor the effects of treatment for a patient with taeniasis. The point-of-care test will benefit US public health by finding patients with taeniasis, the source of transmission. Globally, availability of the taeniasis coproantigen rapid test will allow program managers to find and treat patients with taeniasis and eventually, eliminate taeniasis and reduce global epilepsy burden.
Commercialization Potential
The ELISA kit could be sold to state public health laboratories, and the point-of-care test could be sold to all interested parties.

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