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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

NCT03619798 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2018-08-08

No results posted yet for this study

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.

Conditions

  • Diagnoses Disease

Interventions

DEVICE

HemoTypeSC

Point-of-Care Rapid Test for Detection of Sickle Cell Disease-Relevant Hemoglobin Phenotypes in Whole Blood

Sponsors & Collaborators

  • Silver Lake Research Corporation

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-03
Primary Completion
2018-08-31
Completion
2018-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03619798 on ClinicalTrials.gov