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

Silver Lake Research

Status: Unknown

Conditions: Diagnoses Disease

Treatments: Device: HemoTypeSC

Study type: Observational

Funder types: Industry

Identifiers

NCT03619798

HTSC111

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Previous sickle cell screening