HemoTypeSC Has a CE Mark and is Registered in India, Ghana, Nigeria, Kenya, and Saudi Arabia
HemoTypeSC Has a CE Mark and is Registered in India, Ghana, Nigeria, Kenya, and Saudi Arabia
Now universal hemoglobin screening is possible for newborns, children, and adults worldwide.
According to the study, 3,603 children younger than nine months were screened using HemoTypeSC to show the feasibility of adding newborn screening into existing primary health-care immunizations with rapid testing. This reinforces access to patients with sickle cell in poor communities, a shift from developed countries with better nutrition, bigger financial budgets, and infectious disease vaccines having prominent accessibility, according to the Fogarty International Center at the National Institutes of Health.
The integration of newborn screening into existing primary healthcare immunization programs is feasible and can rapidly be implemented with limited resources, according to a study led by professor Obiageli Nnodu, director of the Centre of Excellence for Sickle Cell Disease Research and Training at Nigeria’s University of Abuja. To realistically screen every newborn for sickle cell disease, Nnodu says a simple, reliable and affordable point-of-care rapid test will be deployed at immunization clinics, a place most newborns will visit soon after birth. One such example is the HemoTypeSC) from Silver Lake Research, a diagnostics firm based in southern California.
The various hematology departments of the three university hospital centers in Côte d'Ivoire recorded in 2014, 11,972 patients suffering from sickle cell anemia, including 8,572 in Yopougon, 3,000 in Cocody and 400 in Treichville, with an average of 600 new cases each year. Patrice Sékongo, country director of the European Institute for Cooperation and Development, called for mass screening and improved patient care thanks to a preventive system that is operational. In a presentation on the evolution of screening tools, Dr Yao Atimeré, a hematologist, presented the HemoTypeSC test, which can detect sickle cell anemia in ten minutes. A solution that comes to save lives.
" '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™.
Nnodu, et al. Lancet Haematol 2020; 7:e534-40.
Between July 14, 2017, and Sept 3, 2019, 3603 newborn babies and infants who presented for immunisation were screened for sickle cell disease at five primary health-care centres using [HemoTypeSC]. We identified 51 (1%) children with sickle cell anaemia (HbSS), four (<1%) heterozygous for HbS and HbC (HbSC), 740 (21%) with sickle cell trait (HbAS), 34 (1%) heterozygous for HbA and HbC (HbAC), and 2774 (77%) with normal haemoglobin (HbAA). Of the 55 babies and infants with confirmed sickle cell disease, 41 (75%) were enrolled into a programme for free folic acid and penicillin, of whom 36 (88%) completed three visits over 9 months (median follow-up 226 days [IQR 198–357]).
Allison Streetly. Lancet Haematol 2020; 7:e503-4.
Nnodu and colleagues show that point-of-care testing is as sensitive and specific as the gold standard laboratory method, high performance liquid chromatography, in this setting. Perhaps most importantly for the sustainability of such initiatives, Nnodu and colleagues show the feasibility of including the testing process into existing immunisation programmes, which already have high uptake. This is a welcome start to developing the idea of a system-wide approach to embedding screening for sickle cell disease into existing care pathways.
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).
