Lateral Flow Immunoassay POC Device for the Diagnosis of Sickle Cell Disease

DESCRIPTION provided by applicant Sickle cell disease SCD and thalassemias are the most common genetic disorders of hemoglobin caused by mutations of the b globin gene Early identification of SCD patients and subsequent provision of comprehensive care will effectively reduce the disease complications and improve life quality and save lives Current SCD diagnostic methods include electrophoresis high performance liquid chromatography HPLC or DNA analysis Although reliable and effective these methods are not suitable for neonatal screening in low resource areas where SCD is most prevalent Therefore there is an urgent need for low cost and accurate point of care diagnostic devices for SCD diagnosis With affordable SCD point of care POC diagnostics newborn screening will become possible for more babies born in low resource areas To fulfill this need we are proposing to use Qoolabs proprietary antibody technology to develop lateral flow immunoassay LFIA devices which can be used to identify SCD and carriers in a few minutes from a drop of patient blood LFIA devices have been widely used in clinical POC diagnostics for over twenty years and have been proven to be low cost sensitive and specific The key component for a successful LFIA device is the antigen specific antibody In this phase I study antibodies specific to hemoglobin variants related to SCD including HbA HbS HbF HbC and HbA will be developed and characterized Each antibody will be produced for the production and testing of LFIA devices Clinical samples from SCD patients will be tested and test results will be correlated with those of conventional methods including HPLC and electrophoresis A K premarket approval or Investigational Device Exemption will be filed with FDA to prepare for clinical trials in phase II in low resource settings Such POC diagnostic devices will have a significant impact on reducing mortality and morbidity related to SCD in low resource areas PUBLIC HEALTH RELEVANCE Sickle cell disease is most prevalent in low resource settings where traditional neonatal screening is not widely available The implementation of a low cost and accurate point of care diagnostic device would make newborn screening possible in low resource areas therefore save many lives and reduce healthcare costs End of Abstract