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.

Inclusion Criteria:

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

Exclusion Criteria:

• Previous sickle cell screening

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.