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 | Unknown

• 1 other identifier: HTSC111
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• Positive for Hemoblogin A, S, or C

  Immediate (investigational test) to one week (reference test)

• Negative for Hemoglobin A, S, or C

  Immediate (investigational test) to one week (reference test)

• Positive for Hemoglobin AA, AS, AC, SS, SC, or CC

  Immediate (investigational test) to one week (reference test)

• Negative for Hemoglobin AA, AS, AC, SS, SC, or CC

  Immediate (investigational test) to one week (reference test)

Interventions

HemoTypeSC DEVICE

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Newborns, children, and adults from neonatal intensive care clinics, maternity wards, and other clinics at various low-, medium-, and high-resource study centers in multiple countries.

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

Sponsors & Collaborators

• Silver Lake Research Corporation: lead

Study Sites (1)

Silver Lake Research Corporation

Azusa, California, 91702, United States

RECRUITING

Central Study Contacts

Erik Serrao, PhD

CONTACT

3103872866; eserrao@silverlakeresearch.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2018
• First Posted: August 8, 2018
• Study Start: August 3, 2018
• Primary Completion: August 31, 2018
• Study Completion: December 31, 2018
• Last Updated: August 8, 2018

Record last verified: 2018-08

Locations

US (1)