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Updated: Dec 17, 2025
A Precision Medicine Tool for Measurement and Monitoring of Hemoglobin S in Sickle Cell Disease Patients Receiving Transfusion Therapy
Implementing newborn screening for sickle cell disease as part of immunisation programmes in Nigeria: a feasibility
Obiageli E Nnodu1, Alayo Sopekan1, Uche Nnebe-Agumadu2
1Sickle Cell Disease Desk, Non-Communicable Disease Unit, Federal Ministry of Health, Federal Secretariat, Abuja, Nigeria.
Insights
Newborn screening for sickle cell disease in Nigeria is feasible using affordable point-of-care tests integrated into immunisation programs. This approach enables early diagnosis and care for children in resource-poor settings.
Area of Science:
- Global Health
- Public Health
- Paediatric Medicine
Background:
- Sickle cell disease (SCD) poses a significant health burden in sub-Saharan Africa, necessitating early diagnosis through newborn screening.
- Current screening methods are often too expensive and technologically demanding for resource-poor countries.
- There is a critical need for affordable, reliable, and accurate SCD screening tools.
Purpose of the Study:
- To assess the feasibility of implementing a SCD newborn screening program using point-of-care (POC) tests.
- To integrate SCD screening into existing primary health-care immunisation programmes in Nigeria.
- To evaluate the accuracy and reliability of POC tests for SCD screening in a resource-limited setting.
Main Methods:
- A prospective feasibility study was conducted in five primary health-care centres in Abuja, Nigeria.
- Newborn babies and infants under 9 months were screened using an ELISA-based POC test (HemoTypeSC) within routine immunisation clinics.
- A subgroup of infants underwent testing with HemoTypeSC, another POC test (SickleSCAN), and the gold standard, high-performance liquid chromatography (HPLC), for comparison.
Main Results:
- Over 3600 infants were screened, identifying 51 cases of sickle cell anaemia (HbSS) and 4 cases of HbSC disease.
- The POC tests demonstrated 100% sensitivity and 100% specificity when compared to HPLC.
- Of the 55 infants diagnosed with SCD, 75% were enrolled in a care program, with high follow-up rates.
Conclusions:
- Integrating SCD newborn screening into existing immunisation programs in primary health-care settings is feasible, even with limited resources.
- Point-of-care tests are accurate and reliable for newborn screening of sickle cell disease.
- This approach offers a promising strategy for improving SCD care in resource-poor countries.
Background:
Sickle cell disease is highly prevalent in sub-Saharan Africa, where it accounts for substantial morbidity and mortality. Newborn screening is paramount for early diagnosis and enrolment of affected children into a comprehensive care programme. Up to now, this strategy has been greatly impaired in resource-poor countries, because screening methods are technologically and financially intensive; affordable, reliable, and accurate methods are needed. We aimed to test the feasibility of implementing a sickle cell disease screening programme using innovative point-of-care test devices into existing immunisation programmes in primary health-care settings.
Methods:
Building on a routine immunisation programme and using existing facilities and staff, we did a prospective feasibility study at five primary health-care centres within Gwagwalada Area Council, Abuja, Nigeria. We systematically screened for sickle cell disease consecutive newborn babies and infants younger than 9 months who presented to immunisation clinics at these five centres, using an ELISA-based point-of care test (HemoTypeSC). A subgroup of consecutive babies who presented to immunisation clinics at the primary health-care centres, whose mothers gave consent, were tested by the HemoTypeSC point-of-care test alongside a different immunoassay-based point-of-care test (SickleSCAN) and the gold standard test, high-performance liquid chromatography (HPLC).
Findings:
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 the ELISA-based point-of-care test. 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]). The head-to-head comparison between the two point-of-care tests and HPLC showed concordance between the three testing methods in screening 313 newborn babies, with a specificity of 100% with HemoTypeSC, 100% with SickleSCAN, and 100% by HPLC, and a sensitivity of 100% with HemoTypeSC, 100% with SickleSCAN, and 100% by HPLC.
Interpretation:
Our pilot study shows that the integration of newborn screening into existing primary health-care immunisation programmes is feasible and can rapidly be implemented with limited resources. Point-of-care tests are reliable and accurate in newborn screening for sickle cell disease. This feasibility study bodes well for the care of patients with sickle cell disease in resource-poor countries.
Funding:
Doris Duke Charitable Foundation, Imperial College London Wellcome Trust Centre for Global Health Research, and Richard and Susan Kiphart Family Foundation.
