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HemoTypeSC, a low-cost point-of-care testing device for sickle cell disease: Promises and challenges
Obiageli Nnodu1, Hezekiah Isa1, Maxwell Nwegbu1
1Centre of Excellence for Sickle Cell Disease Research & Training, University of Abuja, Abuja, Nigeria.
Insights
A new low-cost point-of-care test accurately screens for sickle cell anaemia (SCA) in babies. This accessible sickle cell disease screening tool can be scaled up in sub-Saharan Africa for early diagnosis and management.
Area of Science:
- Global Health
- Hematology
- Point-of-Care Diagnostics
Background:
- Sickle cell disease (SCD) is a significant global health burden, particularly affecting over 312,000 newborns annually, with limited implementation of early interventions in Africa.
- Early diagnosis and intervention, including newborn screening, can drastically reduce SCD-related mortality and morbidity.
- Low-cost point-of-care testing (POCT) devices for sickle haemoglobin (HbS) offer a promising solution for widespread SCD diagnosis.
Purpose of the Study:
- To conduct the first multi-center, real-world assessment of the HemoTypeSC, a low-cost POCT device for sickle haemoglobin (HbS) screening.
- To evaluate the accuracy and feasibility of implementing HemoTypeSC in a low-income country setting for newborn screening.
- To compare the performance of HemoTypeSC against High-Performance Liquid Chromatography (HPLC) and molecular diagnosis.
Main Methods:
- A multi-center study involving 1121 babies screened using both HemoTypeSC POCT and HPLC.
- Discordant results between HemoTypeSC and HPLC were confirmed using molecular diagnostics.
- Data collection, staff training, and confirmatory testing were rigorously managed.
Main Results:
- HemoTypeSC demonstrated high accuracy in optimal field conditions, with a sensitivity of 93.4% and specificity of 99.9% for sickle cell anaemia (SCA).
- The overall accuracy of the HemoTypeSC test was 99.1%, successfully identifying all 14 carriers of haemoglobin C.
- The study highlighted potential unreliability of HPLC in resource-poor settings and emphasized the need for robust data collection and training.
Conclusions:
- The HemoTypeSC POCT device is a reliable and accurate tool for screening sickle cell disease in resource-limited settings.
- Routine implementation across multiple healthcare centers in sub-Saharan Africa can significantly improve the identification and management of individuals with SCD.
- Scaling up this accessible diagnostic technology holds great potential for reducing the impact of SCD in underserved populations.
Background:
Sickle cell disease (SCD) is a neglected burden of growing importance. >312,000 births are affected annually by sickle cell anaemia (SCA). Early interventions such as newborn screening, penicillin prophylaxis and hydroxyurea can substantially reduce the mortality and morbidity associated with SCD. Nevertheless, their implementation in African countries has been mostly limited to pilot projects. Recent development of low-cost point-of-care testing (POCT) devices for sickle haemoglobin (HbS) could greatly facilitate the diagnosis of those affected.
Methods:
We conducted the first multi-centre, real-world assessment of a low-cost POCT device, HemoTypeSC, in a low-income country. Between September and November 2017, we screened 1121 babies using both HemoTypeSC and HPLC and confirmed discordant samples by molecular diagnosis.
Findings:
We found that, in optimal field conditions, 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.
Interpretation:
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.
Funding Us:
Imperial College London's Wellcome Trust Centre for Global Health Research (grant #WMNP P43370).
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