Related Experiment Video
Updated: Mar 2, 2026
A Precision Medicine Tool for Measurement and Monitoring of Hemoglobin S in Sickle Cell Disease Patients Receiving Transfusion Therapy
Towards a point-of-care strip test to diagnose sickle cell anemia
Meaghan Bond1, Brady Hunt1, Bailey Flynn1
1Department of Bioengineering, Rice University, Houston, TX, United States of America.
Insights
A new rapid test accurately identifies sickle cell anemia (SCA) in 15 minutes. This low-cost diagnostic tool shows promise for improving newborn screening in resource-limited regions.
Area of Science:
- Medical Diagnostics
- Point-of-Care Testing
- Hematology
Background:
- Sickle cell anemia (SCA) affects 300,000 newborns annually, primarily in sub-Saharan Africa.
- Existing neonatal screening programs are insufficient in many affected regions.
- Effective low-cost therapies for SCA exist but require early patient identification.
Purpose of the Study:
- To develop and evaluate a rapid, low-cost diagnostic test for sickle cell anemia.
- To enable identification of SCA (HbSS genotype) at the point-of-care.
- To differentiate SCA patients from those with sickle cell trait (SCT) and normal hemoglobin.
Main Methods:
- Development of a competitive lateral flow assay using antibody-coated latex beads.
- Testing with small volumes (0.5-3 μL) of undiluted whole blood.
- Assay run time of 10 minutes, with results available in 15 minutes.
Main Results:
- The assay demonstrated 98% accuracy in differentiating SCA from normal and SCT samples.
- Sensitivity for identifying SCA was 90%, with 100% specificity.
- The test successfully distinguished between SCA and sickle cell trait.
Conclusions:
- The developed lateral flow assay is a significant step towards point-of-care diagnosis of hemoglobinopathies.
- The test shows high accuracy and speed, suitable for resource-limited settings.
- Further validation is required for clinical implementation.
Abstract:
A rapid test to identify patients with sickle cell disease could have important benefits in low-resource settings. Sickle cell anemia (SCA) affects about 300,000 newborns each year, the majority of whom are born in sub-Saharan Africa. Low-cost therapies are available to treat SCA, but most countries in sub-Saharan Africa lack robust neonatal screening programs needed to identify patients in need of treatment. To address this need, we developed and evaluated a competitive lateral flow assay that identifies patients with SCA (genotype HbSS) in 15 minutes using undiluted whole blood. A small volume of blood (0.5 μL- 3 μL) is mixed with antibody-coated blue latex beads in a tube and applied to the strip. Strips are then placed in a well of running buffer and allowed to run for 10 minutes. Laboratory evaluation with samples containing different proportions of hemoglobin A (HbA) and hemoglobin S (HbS) indicated that the test should enable identification of SCA patients but not persons with sickle cell trait (SCT). We evaluated the test using 41 samples from individuals with SCA, SCT, and normal blood. With visual inspection or quantitative analysis, we found a 98% accuracy when differentiating SCA from normal and SCT samples as a group (90% sensitivity and 100% specificity for identifying SCA). This work demonstrates important steps towards making a lateral flow test for hemoglobinopathies more appropriate for point-of-care use; further work is needed before the test is appropriate for clinical use.
