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
- Conditions
- Diagnoses Disease
- Registration Number
- NCT03619798
- Lead Sponsor
- Silver Lake Research Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 600
- Agrees to be enrolled (or has parent/guardian approval to be enrolled)
- Previous sickle cell screening
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Negative for Hemoglobin AA, AS, AC, SS, SC, or CC Immediate (investigational test) to one week (reference test) 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Silver Lake Research Corporation
🇺🇸Azusa, California, United States