Evaluation of HemoTypeSC as a Novel Rapid Test for Point-of-Care Screening for Sickle-Cell Disease, Hemoglobin C Disease, and Carrier Status in Low-Resource Settings

Diagnoses Disease Clinical Trial

Official title: Evaluation of HemoTypeSC as a Novel Rapid Test for Point-of-Care Screening for Sickle-Cell Disease, Hemoglobin C Disease, and Carrier Status in Low-Resource Settings: a Multi-Center

Status Recruiting

Clinical Trial Summary

Sickle cell disease is a life-threatening genetic disorder that can be effectively treated following early diagnosis via newborn screening. However, sickle cell disease is most prevalent in low-resource regions of the world, where newborn screening is rare due to the cost and logistical burden of laboratory-based methods. In many such regions, >80% of affected children die, undiagnosed, before the age of five years. A convenient and inexpensive point-of-care test for sickle cell disease is thus crucially needed. In this study we will conduct a blinded, multicenter, prospective diagnostic accuracy study of HemoTypeSC(TM), an inexpensive 15-minute point-of-care immunoassay for detecting sickle cell disease, hemoglobin C disease, and trait phenotypes in newborns, children, and adults.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Diagnoses Disease

• NCT number: NCT03619798
• Study type: Observational
• Source: Silver Lake Research Corporation
• Contact: Erik Serrao, PhD
• Phone: 3103872866
• Email: eserrao@silverlakeresearch.com
• Status: Recruiting
• Start date: August 3, 2018
• Completion date: December 31, 2018