Diagnostic accuracy of HemoTypeSC for detecting sickle cell disease in newborns: A multicentric study.

ABSTRACT: Background & objectives Sickle cell disease (SCD) is a common, life-limiting genetic disorder in India. It is best managed when diagnosed early through newborn screening, which requires a reliable, rapid and an affordable point-of-care test for diagnosis. The study aimed to evaluate the diagnostic accuracy of HemoTypeSC as point-of care for detecting SCD in newborn screening. Additionally, the study assessed the feasibility of implementing HemoTypeSC in poor resource settings. Methods We conducted a prospective multicentre diagnostic accuracy study using an investigational assay HemoTypeSC, and compared it with the reference ('Gold-standard') High performance liquid chromatography (HPLC) during the year 2019-20. Six different study centers were selected to evaluate the performance of the t

SUBMITTER: Thaker P 

PROVIDER: S-EPMC12744556 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature