Integration of point-of-care testing for sickle cell disease into primary care in northern Ghana: a prospective feasibility study

Background Sickle cell disease contributes substantially to childhood morbidity and mortality in sub-Saharan Africa. However, access to health care remains limited among underserved populations, largely due to financial and structural barriers. Point-of-care testing is affordable and effective for identifying sickle cell disease, yet its implementation within routine health systems in resource-constrained settings remains limited. We aimed to assess the feasibility of integrating point-of-care sickle cell disease screening into routine immunisation services in northern Ghana. Methods We conducted a prospective feasibility study of point-of-care sickle cell disease screening integrated into routine immunisation services at ten primary health care clinics in northern Ghana. Children aged 0–59 months without a previous documented haemoglobin genotype were screened using Gazelle (Hemex Health, Portland, OR, USA) following caregiver consent. Children were excluded if they had a previous diagnosis of sickle cell disease or lived outside the catchment area. Children with presumptive sickle cell disease underwent confirmatory testing with SickleSCAN (BioMedomics, Morrisville, NC, USA) and were linked to specialised care. Outcomes were screening yield, prevalence of confirmed sickle cell disease, rate of confirmation of sickle cell disease, linkage to care, and retention in care at 24 months. Proportions were estimated with corresponding exact binomial 95% CIs. Findings Between Aug 15, 2022, and Sept 30, 2023, 6024 eligible children with consenting caregivers were screened; 2992 (49·7%) were female, 3032 (50·3%) were male, and the median age was 15 months (IQR 5–32). Refusals were not systematically recorded. 3971 (65·9%) of 6024 children had the HbAA genotype, 1146 (19·0%) had HbAC, 720 (12·0%) had HbAS, 106 (1·8%) had HbCC, 58 (1·0%) had HbSC, and 23 (0·4%) had HbSS. 273 (4·5% [95% CI 4·0–55·1]) of 6024 children were identified as having presumptive sickle cell disease, of whom 81 (29·7% [95% CI 24·3–35·5]) were confirmed to have sickle cell disease. Prevalence of confirmed sickle cell disease was 81 (1·3% [1·1–1·7]) of 6024. Of these 81, 79 (97·5% [91·4–99·7]) were enrolled into care. 75 (94·9% [87·5–98·6]) of the 79 enrolled children remained in care at 24 months. The median time from Gazelle screening to SickleSCAN confirmation was 10 days (IQR 3–92; range 0–414). No possible β-thalassaemia traits, inconclusive screening results, adverse events, or serious adverse events were observed. Interpretation Point-of-care sickle cell disease screening was effectively integrated into routine immunisation services for children younger than 5 years using existing primary health-care infrastructure and workforce in northern Ghana, facilitating early diagnosis, linkage to care, and sustained follow-up. These findings highlight the potential of routine child health platforms to expand access to sickle cell disease services in resource-limited settings, although broader implementation will require sustained policy and health system support.