Related Experiment Video
Updated: Apr 3, 2026
A Precision Medicine Tool for Measurement and Monitoring of Hemoglobin S in Sickle Cell Disease Patients Receiving Transfusion Therapy
Validation of a novel point of care testing device for sickle cell disease
Julie Kanter1,2, Marilyn J Telen3, Carolyn Hoppe4
1Pediatrics, Medical University of South Carolina, Charleston, SC, USA. kanter@musc.edu.
Insights
The Sickle SCAN™ test accurately diagnoses sickle cell disease at the point of care. This novel test provides a rapid and accessible diagnostic tool for sickle cell disorders globally.
Area of Science:
- Hematology
- Point-of-care diagnostics
- Inherited blood disorders
Background:
- Sickle cell disease is a common inherited blood disorder with delayed diagnosis in low-resource settings.
- Current diagnostic methods are expensive, time-consuming, and require advanced laboratory systems.
- The Sickle SCAN™ test offers a point-of-care solution for diagnosing sickle cell disease without electricity or advanced equipment.
Purpose of the Study:
- To evaluate and validate the diagnostic accuracy of the Sickle SCAN™ test.
- To assess the test's performance in diagnosing sickle cell disease and trait at the point of care using capillary blood.
Main Methods:
- The Sickle SCAN™ test utilizes advanced, qualitative lateral flow technology.
- It detects hemoglobin A, S, and C in capillary blood, allowing for visual results.
- Laboratory testing and clinical validation were performed on individuals over 1 year of age.
Main Results:
- Laboratory testing showed 99% sensitivity and 99% specificity for various hemoglobin types (HbSS, HbAS, HbSC, HbAC, HbAA).
- Point-of-care validation with capillary blood demonstrated an overall diagnostic accuracy of 99% at the bedside.
- The test correctly identified the presence of hemoglobin A, S, and C.
Conclusions:
- The Sickle SCAN™ test has the potential to significantly impact sickle cell disease diagnosis and treatment worldwide.
- It can enhance genetic counseling at the point of care.
- Further validation in newborns in resource-poor settings is planned.
Background:
Sickle cell disease is one of the most common inherited blood disorders. Universal screening and early intervention have significantly helped to reduce childhood mortality in high-resource countries. However, persons living in low-resource settings are often not diagnosed until late childhood when they present with clinical symptoms. In addition, confirmation of disease in affected individuals in the urgent care setting is limited in both high- and low-resource areas, often leading to delay in treatment. All of the current diagnostic methods rely on advanced laboratory systems and are often prohibitively expensive and time-consuming in low-resource settings. To address this need, the Sickle SCAN™ test has been developed to diagnose sickle cell disease and sickle cell trait at the point of care without electricity or advanced equipment.
Methods:
This study was conducted to evaluate and validate the diagnostic accuracy of the Sickle SCAN™ test, a novel point of care test for sickle cell disease. Thus, we describe the laboratory testing and clinical validation of the Sickle SCAN™ test in individuals >1 year of age using capillary blood. The Sickle SCAN™ test was created using advanced, qualitative lateral flow technology using capillary blood to identify the presence of hemoglobin A, S, and C allowing for detection of results with the naked eye.
Results:
Laboratory testing using venous blood demonstrated 99 % sensitivity and 99 % specificity for the diagnosis of HbSS, HbAS, HbSC, HbAC, and HbAA. Seventy-one subjects underwent capillary blood sampling at the point of care for further validation. This test detected the correct A, S, and C presence with an overall diagnostic accuracy of 99 % at the bedside.
Conclusion:
The Sickle SCAN™ test has the potential to significantly impact the diagnosis and treatment for sickle cell disease worldwide as well as enhance genetic counseling at the point of care. Further validation testing will be conducted in newborns in resource-poor settings in upcoming studies.
