Point-of-care screening for sickle cell disease in low-resource settings: A multi-center evaluation of HemoTypeSC, a novel rapid test

Am J Hematol. 2019 Jan;94(1):39-45. doi: 10.1002/ajh.25305. Epub 2018 Oct 31.


Sickle cell disease (SCD) is a common, life-threatening genetic disorder that is best managed when diagnosed early by newborn screening. However, SCD is most prevalent in low-resource regions of the world where newborn screening is rare and diagnosis at the point-of-care is challenging. In many such regions, the majority of affected children die, undiagnosed, before the age of 5 years. A rapid and affordable point-of-care test for SCD is needed. The diagnostic accuracy of HemoTypeSC, a point-of-care immunoassay, for SCD was evaluated in individuals who had SCD, hemoglobin C disease, the related carrier (trait) states, or a normal hemoglobin phenotype. Children and adults participated in low-, medium- and high-resource environments (Ghana [n = 383], Martinique [n = 46], and USA [n = 158]). Paired blood specimens were obtained for HemoTypeSC and a reference diagnostic assay. HemoTypeSC testing was performed at the site of blood collection, and the reference test was performed in a laboratory at each site. In 587 participants, across all study sites, HemoTypeSC had an overall sensitivity of 99.5% and specificity of 99.9% across all hemoglobin phenotypes. The test had 100% sensitivity and specificity for sickle cell anemia. Sensitivity and specificity for detection of normal and trait states were >99%. HemoTypeSC is an inexpensive (<$2 per test), accurate, and rapid point-of-care test that can be used in resource-limited regions with a high prevalence of SCD to provide timely diagnosis and support newborn screening programs.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adult
  • Anemia, Sickle Cell / blood
  • Anemia, Sickle Cell / diagnosis*
  • Anemia, Sickle Cell / epidemiology
  • Antibodies, Monoclonal / immunology
  • Child
  • Developing Countries
  • Early Diagnosis
  • Female
  • Ghana / epidemiology
  • Hemoglobin A / analysis
  • Hemoglobin C / analysis
  • Hemoglobin C Disease / blood
  • Hemoglobin C Disease / diagnosis
  • Hemoglobin C Disease / epidemiology
  • Hemoglobin, Sickle / analysis
  • Humans
  • Immunoassay* / economics
  • Infant, Newborn
  • Male
  • Martinique / epidemiology
  • Neonatal Screening / economics
  • Neonatal Screening / methods
  • Point-of-Care Systems*
  • Prevalence
  • Prospective Studies
  • Sensitivity and Specificity
  • Sickle Cell Trait / blood
  • Sickle Cell Trait / diagnosis
  • Sickle Cell Trait / epidemiology
  • Single-Blind Method


  • Antibodies, Monoclonal
  • Hemoglobin, Sickle
  • Hemoglobin C
  • Hemoglobin A