Diagnoses Disease
Conditions
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.
Interventions
DEVICEHemoTypeSC
Point-of-Care Rapid Test for Detection of Sickle Cell Disease-Relevant Hemoglobin Phenotypes in Whole Blood
Sponsors
Silver Lake Research Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Agrees to be enrolled (or has parent/guardian approval to be enrolled)
Exclusion criteria
* Previous sickle cell screening
Design outcomes
Primary
| 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) |
Countries
United States
Contacts
Primary ContactErik Serrao, PhD
Outcome results
None listed