This Small Business Innovation Research (SBIR) Phase I project will create a multiplexed point-of-care (POC) testing platform for the assessment and verification of vaccination using whole blood samples. For the rapid assessment of immunization status, both accurate multiplexing and plasma separation from whole blood pose technical hurdles for POC test systems. Lateral flow immunoassays have been limited in achieving multiplexed results from whole blood samples. Plasma separation from blood in sufficient sample volumes, and interferences from neighboring immunoreaction, creates significant technical hurdles for development of an effective POC test for immunity. Moreover, an epitope-specific assessment of immunity has yet to be demonstrated in such a test. The objectives of this proposal will be to create a plasma-generating multiplexed epitope-specific test device for testing immunity to viral diseases. The Phase I project will establish optimum, non-interfering, peptide array configurations on appropriate nitrocellulose surfaces in line with a blood separation material. In parallel, the company will take advantage of epitope mapping technology. The elucidation of multiple vaccine-response epitopes, and the design and validation of peptide affinity-capture analogs to enable quantification of circulating vaccine-response antibodies, will be essential to creating an accurate serological test. The broader impact/commercial impact of this project includes an enhanced technology for multiplexed immunoassay, a more efficient plasma generation system for POC, and a demonstrated methodology for defining antibody responses to immunization. More than 10,000,000 people in the US alone must verify their immunization status each year. This is currently accomplished by providing a verifiable immunization record from a primary health care provider, or by demonstrating proof-of-immunity through appropriate antibody tests. The POC immunization assessment device proposed for this SBIR project will provide a rapid, reliable and lower cost solution for all of those who do not have access to verified immunization records. The devicde avoids the expense and long wait required for antibody titer tests, currently the only option for people without verifiable records. The test system will provide improved, rapid, and inexpensive test methodology as well as a means to capture, analyze, and store the results using common equipment
