Electrokinetic Lateral Flow Tests for Rapid Point-of-Care Diagnosis of Sickle Cel

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DESCRIPTION (provided by applicant): This phase I SBIR proposal describes the development of an electrokinetic lateral flow test (eLFT) for diagnosing sickle cell disease and trait at the point-of-care. This technology will be developed to work in low resource settings where the long-term goal is implementing low-cost neo-natal screening programs that can have an immediate impact on preventing childhood mortality-which reaches upwards of 50-90% for children born with SCD in sub-Saharan Africa. The sickle cell disease eLFT technology is based on a patented sandwich immunoassay format on a next-generation lateral flow test platform actuated by a low power battery for portable and rapid detection. The test will result in high specificity detection of adult hemoglobin (HbA), sickle hemoglobin (HbS), or a combination of the two from whole blood; providing a simple readout corresponding to the patient being negative for sickle cell disease (detect HbA only), positive for sickle cell disease (detect HbS only), or positive for sickle cell trait (detect HbA and HbS). The following specific aims will be achieved during the development of the eLFT diagnostic: 1) production and screening of high quality monoclonal antibodies differentiating HbA from HbS, 2) optimization of the core eLFT microfluidic chip design and assay protocol, 3) development of a portable chip reader, 4) and testing of diagnostic sensitivity and specificity of the final device. Collaboration with the Sickl Cell Foundation of Ghana will inform design and future clinical testing requirements (Phase II) to ensure that the eLFT device is suitable for point-of-care operation in low resource settings including clinics in the developing world.