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
; 94(1): 39-45, 2019 01.
Article
en En
| MEDLINE
| ID: mdl-30290004
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.
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Inmunoensayo
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Sistemas de Atención de Punto
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Anemia de Células Falciformes
Tipo de estudio:
Clinical_trials
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Diagnostic_studies
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Observational_studies
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Prevalence_studies
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Risk_factors_studies
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Screening_studies
Límite:
Adult
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Child
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Female
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Humans
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Male
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Newborn
País/Región como asunto:
Africa
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Caribe
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Martinica
Idioma:
En
Año:
2019
Tipo del documento:
Article