Towards a point-of-care strip test to diagnose sickle cell anemia

PLoS One. 2017 May 16;12(5):e0177732. doi: 10.1371/journal.pone.0177732. eCollection 2017.

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.

Publication types

  • Validation Study

MeSH terms

  • Africa South of the Sahara
  • Anemia, Sickle Cell / blood*
  • Antibodies, Immobilized / immunology
  • Hemoglobin, Sickle / immunology
  • Humans
  • Infant, Newborn
  • Microspheres
  • Point-of-Care Testing / economics*
  • Point-of-Care Testing / standards
  • Reproducibility of Results
  • Sensitivity and Specificity
  • Serologic Tests / economics
  • Serologic Tests / methods*
  • Serologic Tests / standards

Substances

  • Antibodies, Immobilized
  • Hemoglobin, Sickle

Grants and funding

This work was supported by Grant #2013138 from the Doris Duke Charitable Foundation and the National Science Foundation Graduate Research Fellowship for MB under Grant No. 0940902. In addition, one of the co-authors was employed by Perkin Elmer, which provided access to antibodies under an MTA. Perkin Elmer provided support in the form of salaries for an author [PH], but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The specific roles of this author are articulated in the ‘author contributions’ section. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.