Quantitative, Point-of-Care Immunoassay Platform to Guide and Monitor Sickle Cell Disease Therapy

Sickle cell patients often require monthly transfusions with normal blood to treat the many complications of the disease. In this therapy, the clinician lowers the amount of hemoglobin S (HbS) containing red blood cells (RBCs) by transfusing normal blood units containing hemoglobin A (HbA). We have developed a point-of-care (POC) quantitative immunoassay for HbS to serve as a diagnostic aid for clinicians providing this life-saving treatment. The test consists of a small-footprint reader and cartridges that quantify the percentage of HbS in a small volume of patient blood. The test reports % HbS values in the range from 5 to 86% that highly correlate (slope 1.03, R(2) = 0.97) with currently used central laboratory HPLC systems. The test also shows a 1% limit of blank, 2% limit of detection, and 5% limit of quantitation. The test was also shown to encounter minimal effects from potential interferences. This cost-effective, POC HbS quantitative approach will allow for real-time transfusion monitoring in sickle cell treatment settings and therefore improve workflow and allow clinicians to quickly make informed therapeutic decisions.