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Multiplex Detection of Recent and Prior Exposure to Pathogens

Description:

 

Multiplex Detection of Recent and Prior Exposure to Pathogens

Phase I SBIR proposals will be accepted.

Fast-Track proposals will not be accepted.

Phase I clinical trials will not be accepted.

Number of anticipated awards: 1

Budget (total costs): Phase I: up to $150,000 for up to 6 months

PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED.

Background

Recent advances in high-throughput assay technologies have allowed for simultaneous detection of multiple pathogens, either by direct detection of antigens and genetic materials (DNA/RNA), and/or antibodies and other immune factor responses against those pathogens. Although both of these methods of disease detection provide critical information to clinical and public health professionals, the implication of positive test results are different. Antigens and DNA/RNA detect pathogens directly, and are usually mostly indicative of active disease, thereby providing information relevant for clinical treatment and intervention. Antibody tests indicate immune response to a pathogen, and can indicate either active/recent disease or past exposure to a pathogen. Because of this, antibody detection assays are more useful for disease surveillance, but detection of specific immunoglobulin isotypes (IgG, IgM, IgE, IgA) may also inform the clinical progression of disease, past or present. Likewise, the interplay of immune factors such as chemokines and cytokines determine individual responses to infection, and

can inform clinicians to predict outcomes, and thereby select appropriate interventions. Currently, there are no multiplex assays that exploit both antigen detection and immune response to multiple pathogens.

Project Goals

The goal of this project is to solicit the innovative development of diagnostic testing platforms that can simultaneously detect antigens of multiple pathogens and different antibody isotypes and/or immune factors against those pathogens in a single multiplex assay. The pathogens of interest include, but are not limited to, those with a high potential for causing global disease outbreaks that affect vulnerable populations (e.g., children, pregnant women, the elderly, etc.), and those targeted for global disease elimination or eradication.

Phase I Activities and Expected Deliverables

During the Phase I period, the project research shall identify a list of relevant pathogens, appropriate antigens and reactive antibody isotypes (e.g., IgG, IgM, IgA, etc.) to these pathogens that will be included in the single multiplex testing platform format. The multiplex assay performance will be optimized for sensitivity and specificity using mock (spiked) and real clinical specimens.

Impact

By combining antigen and antibody detection to multiple pathogens in a single multiplex assay, both clinical and public health professionals would be empowered to determine the clinical stages of infection and treatment outcomes amongst affected individuals. Additionally, the burden of disease within specific populations could be assessed and monitored so that targeted disease interventions and prevention programs can be monitored for their efficacy.

Commercialization Potential

A multiplex assay that detects both antigens and immune responses to several pathogens would be of great interest to both the clinical and the public health sectors. Such an assay would be useful in a clinical setting to rule out or confirm potential disease etiologies, and useful in a population setting to determine specific foci for interventions to improve community health and prevent disease outbreaks.

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