Rapid LFIA blood test for SCD using highly specific monoclonal antibodies

DESCRIPTION provided by applicant Neonatal screening for sickle cell disease SCD and other hemoglobinopathies has been shown to reduce morbidity and mortality of affected individuals through early intervention and to also reduce the healthcare burden of this common group of disorders However traditional screening methods are laborious and costly and thereby often inappropriate for low resource settings in areas of high prevalence of SCD We propose the development of a rapid simple and inexpensive lateral flow immunoassay LFIA test kit for the point of care detection of hemoglobin phenotypes directly in whole blood samples This convenient and inexpensive assay format has proven to be an accurate and reliable diagnostic methodology for a variety of POC applications where a rapid assay is needed The proposed LFIA for hemoglobin phenotypes will utilize highly specific monoclonal antibodies MAbs for HbA HbS and HbC recently developed by Silver Lake Research using a proprietary antibody generation system By using these MAbs in a single test the proposed LFIA will be able to identify and distinguish between the most common SCD phenotypes including normal HbAA HbSS HbAS HbCC HbSC and HbS boThal The proposed test kit will also include an inexpensive disposable sample preparation component capable of rapidly preparing a whole blood sample or dried blood spot filter for analysis by the LFIA test strip SLRCandapos s existing LFIA formats used in tests currently manufactured by the Company share a low cost production platform that will enable the delivery of tests to the end user at andlt $ per unit SLRC has over years of experience in LFIA development and production with more than marketed LFIA products originally designed developed and manufactured at SLRC PUBLIC HEALTH RELEVANCE Newborn screening for sickle cell disease has proven to dramatically improve patient outcomes and reduce the healthcare burden of SCD but available methods of screening are not practicable in low resource settings where most SCD cases occur We propose the development of a rapid simple and inexpensive test kit to detect SCD by using novel specific antibodies to the mutant hemoglobins that define the disease The proposed test kit promises to enable on the spot SCD diagnosis in low resource settings making possible immediate intervention and significant benefits to both patients and healthcare providers End of Abstract