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1.
Am J Hematol ; 94(1): 39-45, 2019 01.
Article in English | 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.


Subject(s)
Anemia, Sickle Cell/diagnosis , Immunoassay , Point-of-Care Systems , Adult , Anemia, Sickle Cell/blood , 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 , Prevalence , Prospective Studies , Sensitivity and Specificity , Sickle Cell Trait/blood , Sickle Cell Trait/diagnosis , Sickle Cell Trait/epidemiology , Single-Blind Method
2.
J Clin Microbiol ; 41(12): 5650-3, 2003 Dec.
Article in English | MEDLINE | ID: mdl-14662956

ABSTRACT

A rapidly growing mycobacterium was isolated five times from blood cultures from a 6-year-old female patient with relapsed pre-B-cell acute lymphocytic leukemia. All five isolates had identical nucleotide sequences for the first 500 bp of the 16S rRNA gene, indicative of a single species. High-performance liquid chromatography analysis of mycolic acids indicated that the species was similar to Mycobacterium smegmatis. Sequence analysis of the 16S rRNA gene (1,455 bp) for one isolate demonstrated that the species was closely related to Mycobacterium diernhoferi. Based on the phenotypic features and phylogenetic analysis, it was concluded that the isolates represented a novel rapidly growing Mycobacterium species. The name "Mycobacterium hackensackense" is proposed for this unique strain, 147-0552(T), which was deposited in the American Type Culture Collection as ATCC BAA-823(T).


Subject(s)
Mycobacterium/classification , Sepsis/microbiology , Base Sequence , Child , Chromatography, High Pressure Liquid , DNA, Bacterial/genetics , DNA, Bacterial/isolation & purification , DNA, Ribosomal/genetics , DNA, Ribosomal/isolation & purification , Female , Humans , Microbial Sensitivity Tests , Mycobacterium/drug effects , Mycobacterium/growth & development , Mycobacterium/isolation & purification , Mycobacterium smegmatis/classification , Mycobacterium smegmatis/genetics , Mycobacterium smegmatis/isolation & purification , RNA, Bacterial/genetics , RNA, Bacterial/isolation & purification , RNA, Ribosomal, 16S/genetics , RNA, Ribosomal, 16S/isolation & purification , Sepsis/drug therapy
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