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

Status unconfirmed

Conditions studied: Diagnoses Disease

In brief

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.

Key facts

Study ID

NCT03619798

Run by

Silver Lake Research Corporation

People needed

600

Starts

2018-08-03

Expected to finish

2018-12-31

Last updated by the study team

2018-08-08

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Agrees to be enrolled (or has parent/guardian approval to be enrolled)

You may not qualify if…

• Previous sickle cell screening

Where it is running

• Silver Lake Research Corporation — Azusa, California, United States (enrolling)

Full record on ClinicalTrials.gov

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