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

Diagnoses Disease Clinical Trial

Official title:

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: a Multi-Center

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03619798
• Other study ID #: HTSC111
• Status: Recruiting
• Start date: August 3, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: August 2018
• Source: Silver Lake Research Corporation
• Contact: Erik Serrao, PhD
• Phone: 3103872866
• Email: eserrao[@]silverlakeresearch.com
• Is FDA regulated: No
• Study type: Observational

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Previous sickle cell screening

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Diagnoses Disease

Intervention

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

Locations

Country	Name	City	State
United States	Silver Lake Research Corporation	Azusa	California

Sponsors (1)

Lead Sponsor	Collaborator
Silver Lake Research Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive for Hemoblogin A, S, or C		Immediate (investigational test) to one week (reference test)
Primary	Negative for Hemoglobin A, S, or C		Immediate (investigational test) to one week (reference test)
Primary	Positive for Hemoglobin AA, AS, AC, SS, SC, or CC		Immediate (investigational test) to one week (reference test)
Primary	Negative for Hemoglobin AA, AS, AC, SS, SC, or CC		Immediate (investigational test) to one week (reference test)