Sickle SCAN could revolutionize the survival prospects for children born with sickle cell disease in resource-limited areas.” Thomas N. William, Chair in Hemoglobinopathy, Dept of Medicine, Imperial College of Lond

Background on Sickle Cell Disease Sickle cell disease (SCD) is a painful and life threatening hereditary hematological disorder affecting approximately 400,000 newborns annually worldwide.(1) 50 - 90% of children with SCD will die if their condition is undetected. Early diagnosis is crucial to initiating life-saving therapies.(2) Knowledge of sickle cell carrier status is also an important part of parental planning for at-risk populations. All current diagnostic methods for SCD rely on advanced laboratory systems and are often prohibitively expensive and time-consuming in developing countries....

The tube containing the sample is dipensed into the buffer solution and mixed well by inverting 3 times. Then 5 drops of the lysate are added to the sample well in the Sickle SCAN cartridge. The test result is often visible within 1 minute, but the final result is scored after 5 minutes with a blue band indicating the presence of corresponding hemoglobin. The speed of the test allows for real-time communication of results between the clinician and the patient. Moreover, the test requires no electricity and should avoid the cost and added complexity of sample transport and the feedback of results....

Limit of Detection The Sickle SCAN™ limit of detection for hemoglobins A, S, and C is determined to be <10%, <10%, and <10%, respectively. Limit of Detection Hemoglobin A Table 2 - Sickle SCAN Limit of Detection for HbA, HbS, and HbC Sensitivity and Specificity Sickle SCAN was compared to High Performance Liquid Chromatography (HPLC) using guidelines outlined in CLSI document EP15-A2-IR. Patient samples (n=290) were collected and measured in duplicate on both systems. SS Table 3 - Sickle SCAN performance compared to genotypes identified by HPLC Interfering Factors Sickle SCAN demonstrates ≤ 10%...