HemoTypeSC Has a CE Mark and is Registered in Ghana, Nigeria, and Kenya
HemoTypeSC Has a CE Mark and is Registered in Ghana, Nigeria, and Kenya
Now universal hemoglobin screening is possible for newborns, children, and adults worldwide.
" 'HemoTypeSC is an accurate, inexpensive, and rapid tool that can enable sickle cell disease screening programs across rural areas of Africa and India, where it's not being screened for at all,' - late-breaking abstract press briefing at the American Society of Hematology meeting."
Erik Serrao discusses the data from a recently-completed field validation trial in southeastern Uganda. In this collaboration with the Sickle Cell Association of Uganda, led by Ruth Nankanja, HemoTypeSC correctly identified the hemoglobin type of 1,000 out of 1,000 children screened.
Dr. Alayo Sopekan, National Desk Officer, Ministry of Health, said: “Nigeria has the highest burden of Sickle Cell Disease (SCD) in the world ahead of Democratic Republic of Congo and India.” He called for early diagnosis and treatment of the disease.
Video: Nigerian officials reveal how the country loses over 150,000 newborns to sickle cell disease every year. OakTV presents a report on the accuracy of HemoTypeSC™, a 10 minute investigational test kit.
Video: Professor Obiageli Nnodu, sickle cell disease expert from the University of Abuja, describes the current status of sickle cell disease in Nigeria and the results from early testing with HemoTypeSC™.
Mukherjee, et al. Am J Clin Pathol. 2019 Aug 1.
A total of 1,559 individuals (980 newborns and 579 adults) from four participating centers were analyzed... HemoTypeSC correctly identified 209 of 211 total hemoglobin (Hb) SS cases, for a 99.1%/99.9% total HbSS sensitivity/specificity. Overall, HemoTypeSC exhibited sensitivity and specificity of 98.1% and 99.1% for all possible phenotypes (HbAA, HbAS, and HbSS) detected. HPLC is relatively expensive and not available in most laboratories in remote tribal areas. We conclude that the rapid, point-of-care testing device HemoTypeSC test is suitable for population and newborn screening for the HbS phenotype.
Nankanja, et al. Am J Hematol. 2019 Mar 11
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 cost per-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.
Nnodu, et al. Blood Cells Mol Dis. 2019 Sep;78:22-28
We found that...the sensitivity and specificity of the test for SCA were 93.4% and 99.9%, respectively. All 14 carriers of haemoglobin C were successfully identified. Our study reveals an overall accuracy of 99.1%, but also highlights the importance of rigorous data collection, staff training and accurate confirmatory testing. It suggests that HPLC results might not be as reliable in a resource-poor setting as usually considered. The use of such a POCT device can be scaled up and routinely used across multiple healthcare centres in sub-Saharan Africa, which would offer great potential for the identification and management of vast numbers of individuals affected by SCD who are currently undiagnosed.
Steele, et al. Am J Hematol. 2018 Oct 5.
Here, we describe a global, multicenter evaluation of the diagnostic performance of HemoTypeSC for detecting sickle cell disease, HbC disease, and the related carrier states (HbS trait and HbC trait) using whole blood at the point-of-care in limited-resource environments. The test had 100% sensitivity and specificity for sickle cell anemia. Sensitivity and specificity for detection of normal and trait states were >99%.
Quinn, et al. Br J Haematol. 2016 Nov;175(4):724-732.
This manuscript details our initial laboratory development of HemoTypeSC™, based on novel monoclonal antibodies (MAbs) that differentiate normal adult haemoglobin (Hb A), sickle haemoglobin (Hb S) and haemoglobin C (Hb C).
