LAUSR

tant or unable to devote adequate budget and resources in order to and establish diagnostic screening efforts. Clearly, an accurate, low-cost test that can rapidly determine hemoglobin type at the point-of-care could form the foundation of such screening efforts. In this study we implemented a sustainable screening effort for SCD at a typical resource-constrained medical center in a high disease prevalence region of southeastern Uganda. The HemoTypeSC test was performed efficiently, results were highly accurate, and the costper-test of HemoTypeSC ($2.00) was approximately 1/6th that of the existing gold-standard diagnostic method (~$12.00). The results from this study indicate that HemoTypeSC performs at least as accurately as the gold-standard method of CZE in detecting SCD and sickle cell trait at the POC in a resource-limited setting. This to our knowledge represents the first ever report of a rapid test for SCD displaying 100% sensitivity and specificity in a field validation study. While our detected frequency of HbS variant and of SCD trait is in line with previous reports for southeastern Uganda, the 9.6% prevalence of homozygous disease (confirmed by both the reference and investigational test methods) is unexpectedly high. We hypothesize that this may be a result of both consanguinity and self-selection of the patient pool, as some recruited individuals may have presented at the Jinja Regional Referral Hospital with illnesses and symptoms due to SCD along with their family members. In summary, HemoTypeSC represents a promising tool that can presently enable newborn and general population screening. Widespread combination of HemoTypeSC newborn and population screening programs with appropriate treatment, prophylaxis, and health counseling systems in countries most affected by the disease could save the lives of millions of children over the coming decades.