SILVER LAKE RESEARCH CORPORATION — Department of Health and Human Services SBIR Phase II: NHLBI

Description

PROJECT SUMMARY ABSTRACT This proposal describes Phase II of the development of a rapid immunoassay test kit for the determination of hemoglobin variants in blood to be used as a point of care diagnostic test for sickle cell disease SCD and SCD carrier trait in low resource settings worldwide Today determination of SCD and SCD trait requires lengthy and expensive laboratory analyses that are not available in low resource settings and andgt of individuals with SCD and SCD trait live in areas where healthcare is provided in those settings Nevertheless newborn screening programs have resulted in significant improvement of patient outcomes due to early treatment to prevent complications of the disease The proposed test kit will be a lateral flow immunoassay similar in principle to a home pregnancy test The test design is based on monoclonal antibodies MAbs specific for the single amino acid differences between SCD related hemoglobin variants In Phase I the applicant developed a working prototype hemotyping test kit which was shown to correctly identify the phenotype of andgt of tested whole blood samples including each relevant SCD and carrier phenotype The prototype test requires a microliter volume of blood and the time to result is under minutes In Phase II the test kit will be further improved and simplified and a complete manufacturable product will be developed Clinical validation studies will be carried out to determine the real world performance of the product including studies performed in low resource settings in Brazil At the successful conclusion of Phase II the test kit will be ready for manufacturing and submission for approval to regulatory agencies worldwide The estimated cost of the hemotyping test kit will be $ a price point that will allow widespread acceptance of this test kit in developing countries PROJECT NARRATIVE Sickle cell disease is prevalent in developing countries where current instrument intensive diagnostic testing is not available due to cost and technology barriers This proposal continues the development an accurate simple inexpensive and rapid test for determination of SCD and SCD carrier status in low resource settings