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Point‐of‐care screening for sickle cell disease in low‐resource settings: A multi‐center evaluation of HemoTypeSC, a novel rapid test
Author(s) -
Steele Cindy,
Sinski Annette,
Asibey Jacqueline,
HardyDessources MarieDominique,
Elana Gisèle,
Brennan Colleen,
Odame Isaac,
Hoppe Carolyn,
Geisberg Mark,
Serrao Erik,
Quinn Charles T.
Publication year - 2019
Publication title -
american journal of hematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.456
H-Index - 105
eISSN - 1096-8652
pISSN - 0361-8609
DOI - 10.1002/ajh.25305
Subject(s) - medicine , point of care , newborn screening , point of care testing , sickle cell trait , disease , sickle cell anemia , pediatrics , anemia , dipstick , immunology , pathology , urine
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.