Implementing newborn screening for sickle cell disease as part of immunisation programmes in Nigeria: a feasibility study

Abstract

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 a lateral flow immunoassay-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).

Feasibility and acceptability of early infant screening for sickle cell disease in Lagos, Nigeria—A pilot study

“…HemoTypeSC is affordable, rapid, reliable and accurate diagnostic testing for early infants’ screening programs for SCD in low-resource countries where the prevalence of SCD is high without an organized national newborn screening program [ 19 ]. A similar and larger study in Abuja Nigeria also reported a sensitivity and specificity of 100% with HemoTypeSC and have demonstrated point-of-care tests as reliable and accurate in newborn screening for SCD [ 21 ].…”

“…One hundred and eighty-five (74%) of the infants had their haemoglobin genotypes as AA. A similar study in Abuja, Nigeria reported a prevalence of 1·4% for HbSS, 20·5% for HbAS and HbAA 77% [ 21 ]. Another similar study in Awka South-East Nigeria reported a prevalence of 0.3% for HbSS and 75% for HbAA genotype amongst newborns [ 36 ].…”

“…A multi-centre study in Nigeria which assessed a low-cost POCT device, HemoTypeSC reported the sensitivity and specificity of 93.4% and 99.9% respectively for the test [ 19 ]. Another study that tested 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 in Nigeria reported 100% sensitivity and specificity of HemotypeSC test in the detection of SCD [ 21 ]. Similarly, a study on point-of-care screening for SCD in low-resource settings reported 100% sensitivity and specificity for SCD [ 22 ].…”

Perspectives on Building Sustainable Newborn Screening Programs for Sickle Cell Disease: Experience from Tanzania

“…Point of care testing (POCT) has been recommended as the most cost effective solution for diagnosis of SCD in places with high burden of the disease and limited resources [ 19 , 41 ]. Data from pilot studies on POCT implemented in Africa demonstrated both affordability and reliability of the tests [ 22 , 42 ]. Collectively, these data provide strong evidence on the potential of POCT to be standard practice for SCD diagnosis with the aim of expanding screening coverage.…”

“…Establishing screening programs in existing programs and health care infrastructure was recommended by the implementers and policy makers as one of the sustainability strategies. The pilot NBS for SCD that was implemented through the immunization program in Nigeria provided evidence on the feasibility and sustainability of the model in limited resource areas [ 42 ]. Leveraging the limited resources through working with other developed programs in the settings has also been recommended through other experiences [ 4 , 21 , 43 ].…”