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

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

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.

Study Overview

• Status: Unknown
• Conditions: Diagnoses Disease
• Intervention / Treatment: Device: HemoTypeSC

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

• Study Contact: Name: Erik Serrao, PhD; Phone Number: 3103872866; Email: eserrao@silverlakeresearch.com

Study Locations

• United States
  • California
    • Azusa, California, United States, 91702
      • Recruiting
      • Silver Lake Research Corporation
      • Contact: Erik Serrao; Phone Number: 310-387-2866; Email: eserrao@silverlakeresearch.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Previous sickle cell screening

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: Silver Lake Research Corporation

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 3, 2018
• Primary Completion (ANTICIPATED): August 31, 2018
• Study Completion (ANTICIPATED): December 31, 2018

Study Registration Dates

• First Submitted: August 3, 2018
• First Submitted That Met QC Criteria: August 3, 2018
• First Posted (ACTUAL): August 8, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 8, 2018
• Last Update Submitted That Met QC Criteria: August 3, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Anemia, Sickle Cell; Hemoglobin C Disease
• Other Study ID Numbers: HTSC111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No