Multicenter Evaluation of HemoTypeSC as a Point-of-Care Sickle Cell Disease Rapid Diagnostic Test for Newborns and Adults Across India
| Autor: | Yazdi M. Italia, Erik Serrao, Roshan B. Colah, Dipty Jain, Shrey Desai, Nikhil Shinde, Bhavesh Raicha, Malay B. Mukherjee, Kapilkumar Dave, Pallavi Mehta |
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| Rok vydání: | 2019 |
| Předmět: |
Adult
Pediatrics medicine.medical_specialty Point-of-care testing Point-of-Care Systems Population Hemoglobin Sickle India Disease Anemia Sickle Cell 03 medical and health sciences 0302 clinical medicine medicine Humans Prospective Studies education Chromatography High Pressure Liquid Point of care Newborn screening education.field_of_study Rapid diagnostic test business.industry Infant Newborn Hemoglobin A General Medicine Gold standard (test) medicine.disease Sickle cell anemia Phenotype Point-of-Care Testing 030220 oncology & carcinogenesis business 030215 immunology |
| Zdroj: | American journal of clinical pathology. 153(1) |
| ISSN: | 1943-7722 |
| Popis: | Objectives Sickle cell anemia is the commonest genetic disorder in India, and the frequency of the sickle cell gene is very high in the remote tribal areas where facilities are generally limited. Therefore, a rapid and affordable point-of-care test for sickle cell disease is needed. Methods The diagnostic accuracy of HemoTypeSC was evaluated against automated high-performance liquid chromatography (HPLC) as the gold standard for its efficacy in a newborn screening program. Results A total of 1,559 individuals (980 newborns and 579 adults) from four participating centers were analyzed by both methods. HemoTypeSC correctly identified 209 of 211 total hemoglobin (Hb) SS cases, for a 99.1%/99.9% total HbSS sensitivity/specificity. Overall, HemoTypeSC exhibited sensitivity and specificity of 98.1% and 99.1% for all possible phenotypes (HbAA, HbAS, and HbSS) detected. HPLC is relatively expensive and not available in most laboratories in remote tribal areas. Conclusions We conclude that the rapid, point-of-care testing device HemoTypeSC test is suitable for population and newborn screening for the HbS phenotype. |
| Databáze: | OpenAIRE |
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