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 HbA2 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 510K 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.
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)