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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


Study Design


Related Conditions & MeSH terms


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

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