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

Point-of-care Screening for Sickle Cell Disease in Low-Resource Settings: A Multi-Center Evaluation of HemoTypeSC, a Novel Rapid Test

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Free PMC article
Clinical Trial

Point-of-care Screening for Sickle Cell Disease in Low-Resource Settings: A Multi-Center Evaluation of HemoTypeSC, a Novel Rapid Test

Cindy Steele et al. Am J Hematol. .
Free PMC article

Abstract

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.

Conflict of interest statement

CONFLICTS OF INTEREST

The other authors report no potential conflicts of interest.

Figures

Figure 1.
Figure 1.. Participant Enrollment and Construction of Main Analysis Population
Newborns, children, and adults were registered for the study from low- (Ghana), medium- (Martinique), and high-resource testing environments. A total of 20 participants (mostly very small newborns) were initially excluded from the study due to the lack of adequate collected blood volume for confirmatory testing. Ultimately, 588 individuals were enrolled in the study, and Hb screening was conducted by comparing HemoTypeSC to three separate, clinically established reference methods (agarose gel electrophoresis, IEF, and capillary zone electrophoresis). Following a final exclusion of one specimen producing indeterminate reference method results, a total of 383 results from Ghana, 46 results from Martinique, and 158 results from the USA (total N=587) comprised the main analysis population.

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