Determination of birth prevalence of sickle cell disease using point of care test HemoTypeSC TM at Rundu hospital, Namibia

Determination of birth prevalence of sickle cell disease using point of care test HemoTypeSC TM at Rundu hospital, Namibia | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Determination of birth prevalence of sickle cell disease using point of care test HemoTypeSC TM at Rundu hospital, Namibia Runyararo Mashingaidze Mano, Patience Kuona, Jane Masiiwa Misihairabgwi This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-3753291/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 10 May, 2024 Read the published version in BMC Pediatrics → Version 1 posted 10 You are reading this latest preprint version Abstract Background : Sickle cell disease (SCD), a non-communicable disease has its highest burden in Sub Saharan Africa. The majority of children (50-90%), with SCD die before their 5 th birthday with approximately 150,000–300,000 annual SCD child deaths in Africa. In developed countries, newborn screening (NBS) has been shown to improve survival of children with sickle cell disease with under 5 childhood mortality reduced 10 fold due to interventions done before development of complications. Point of care tests have been developed for resource limited settings to expand newborn screening. The aim of the study was to determine the birth prevalence of sickle cell disease using the point of care test HemoTypeSC in Namibia. Methods : A cross sectional descriptive study was carried out at Rundu Intermediate hospital in Kavango East Region. Two hundred and two (202) well newborns within 72 hours of birth were recruited in the study from 22 of February to the 28 th of March 2023. Descriptive statistics was used to compute the hemoglobin types of the study participants. Results : The majority of the participants (n=105) (52%) were females and (n= 97) ,(48%) males. The median age of the participants was 23 hours interquartile range (IQR), (11-33 hours) with the age range of 2-98 hours. One hundred and eight three (183) ( 90.6%) had normal haemoglobin HbAA; 19 (9.4%) sickle cell trait (HbAS) and no participant was found to have sickle cell disease (HbSS). Conclusions : The study is the first to carry out birth prevalence for SCD and sickle cell trait as well as the first application of HemotypeSC as screening method in Namibia. There was a high prevalence of sickle cell trait but no SCD. This is a baseline study that can inform policy on the possible adoption of sickle cell disease newborn screening in Namibia. Hemotype SC™ newborn screening sickle cell disease malaria prone region Figures Figure 1 Figure 2 Figure 3 Background Sickle cell disease (SCD), a non-communicable disease, has its highest burden in Sub Saharan Africa and is the most frequent genetic haemoglobinopathy, with over 300 000 children born with the disease annually and this number is expected to increase to 400 000 by 2050 ( 1 – 3 ). The majority of these children (50–90%), die before their 5th birthday with approximately 150,000–300,000 annual SCD child deaths in Africa ,which can potentially accounting for 5–10% of the region’s total child mortality ( 1 , 4 , 5 ). Nearly 90% of SCD patients live in 3 countries, Nigeria, India and Democratic Republic of Congo. In these countries nearly 2% of the population have SCD with a carrier rate, sickle cell trait, ranging from 10–30% ( 6 ). However, it has been found recently that the distribution of all the hemoglobin disorders is extremely diverse within different countries, even within small geographical distances ( 7 ). Sickle cell disease (SCD) is a genetic autosomal recessive disorder which results from substitution of valine for glutamine at position 6 of the beta chain haemoglobin. The haemoglobin (HbSS) tetramer that results from the substitution has alpha 2 and beta S2, is poorly soluble and rigid when deoxygenated resulting in vaso-occlusion which in turn causes several complications ( 8 ). Moreover, there are different forms of sickle cell disease which include HbSS, HbSC, HbS beta thalassaemia, HbSE, and HbSD and many more and it occurs throughout sub-Saharan Africa, and in small pockets in the Mediterranean region, the Middle East and Indian subcontinent ( 9 ). The HbSC disease is restricted to parts of west and North Africa, HbS thalassemia is localised in parts in sub-Saharan Africa, some parts of the Middle East and India subcontinent. Additionally, HbSE occur commonly in India, Bangladesh, Myammer and east and southeast Asia ( 9 ). Among SCD variants, HbSS is the commonest in the sub-Saharan region and is associated with severe forms of complications in comparison with the other variants. These complications include but are ,not limited to priapism, pulmonary emboli, osteonecrosis, and ultimately damages every organ system including the spleen, retinae, kidneys and liver( 10 ). Sickle cell trait the heterozygous form of HbS is the carrier state for sickle cell haemoglobin. These individuals inherit HbS/C from one parent and HbA from the other parent making them heterozygous (HbAS) or HbAC. More than 100 million or about 5% of the world population have the sickle cell trait (SCT) ( 11 ). Most people with sickle cell trait live asymptomatically. Despite SCT being perceived as an asymptomatic condition several case reports and reviews reported an increased incidence of renal medullary carcinoma among young patients with SCT with the age wide from 9 to 69 years ( 12 – 14 ). Other forms of SCT include HbAC, and HbAE although these are rare forms ( 9 ). The gene for sickle hemoglobin (HbS) is a prime example of natural selection. It is generally believed that its current prevalence in many tropical populations reflects selection for the carrier form (sickle cell trait (HbAS) through a survival advantage against death from malaria ( 15 ). A study by Williams et al, 2005 ( 15 ) showed that HbAS had no effect on the prevalence of symptomless parasitaemia but was 50% protective against mild clinical malaria, 75% protective against admission to the hospital for malaria, and almost 90% protective against severe or complicated malaria. Malaria remains a major public health problem in Namibia mostly in Kavango East and West, Ohangwena and Zambezi regions. The 4 regions accounted for 96% of cases with Kavango East and West accounting for 81%, Zambezi 10% and Ohangwena 5% according to a recently published study (2023) by Katale and Gemechu( 16 ). Early detection of sickle cell disease or trait is imperative to the long term outcome as treatment can be initiated early. In developed countries, newborn screening (NBS) has been shown to improve survival of children with sickle cell disease with under 5 childhood mortality reduced 10 fold due to interventions done before development of complications ( 17 ). Over the years, several techniques have been employed to diagnose and monitor SCD. High performance liquid chromatography (HPLC and isoelectric focusing( IEF) are the two main laboratory techniques for haemoglobinopathy screening currently suitable for routine use and have been used in developed countries and several studies in Africa ( 18 ). Molecular genetic tests are considered the gold standard tests as they target the affected genes and are able to distinguish the different mutations ( 19 ). These include Restriction Fragment Polymorphism (RFLP) partial restriction of deoxyribonucleic acid (DNA), Real-time polymerase chain reaction (PCR) ( 20 ) and DNA sequencing which is the most expensive molecular method compared to RFLP and PCR because of reagents, instrumentation, personnel and review time required for analysis, but it provides the most comprehensive data for beta-globin gene ( 20 ). Point of care tests (POCT), SCD screening methods validated in developing countries, are easier to perform and require less qualified personnel with results available within a short period of time( 21 ). These tests provide results within a short period of time. Sickle cell SCAN™, a lateral flow assay reliably identifies HbA, HbS, and HbC, easily performed by non-skilled personnel, easily interpreted, rapid test at the point of care ( 21 ). This test detected the correct A, S, and C presence with an overall diagnostic accuracy of 99% at the bedside ( 22 ). However it is relatively more expensive than other POCTs. Other novel POCTs include Heme Cheap, which is reliable, able to distinguish most types of sickle cell disease including compound heterozygotes. However, it requires skilled interpretation, web-based, automated and this is out of reach of most resource limited regions ( 21 ). Additionally, Aqueous multiphase System (AMPS) (density based test to separate Hb in different density fluids) and Paper based Sickle test (microfluid assessment) are inexpensive and require non-skilled personnel. However, the interpretation maybe difficult and the later requires a scanner for interpretation ( 21 , 23 ). Lately, HemoTypeSC™, a POCT a monoclonal antibody based which targets Hb A, S, and C but not Hb F is one of the newest techniques yield results in 10 minutes ( 24 , 25 ). Multiple studies found HemoTypeSC™ to have a sensitivity and specificity of over 98% compared to the gold standard methods of HPLC and IEF ( 22 , 26 – 31 ). Success in implementation of newborn screening programs include health education of stake holders ( 32 ). The HemotypeSC point-of-care testing device has shown high sensitivity and specificity for diagnosing sickle cell disease (SCD) in various studies. A study by Olatunya et al, 2021 found that HemotypeSC had perfect concordance with PCR and 100% accuracy in diagnosing SCD, while Nnodu et al, 2019 reported a sensitivity of 93.4% and a specificity of 99.9% for SCD ( 26 , 33 ). In addition, Okeke, 2022 further demonstrated the feasibility of using dried blood spots with HemotypeSC, with a sensitivity and specificity of 100% compared to the standard test ( 31 ). A further study by Adegoke et al 2022,( 34 ) also found high sensitivity of HemotypeSC when compared to alkaline cellulose acetate hemoglobin electrophoresis. These findings collectively suggest that HemotypeSC is a reliable and accurate tool for SCD diagnosis. Although other POCT test such as Sickle SCAN have been validated in some parts, Hemotype SC has shown to be cheaper and easy to use ( 35 , 36 ). New born screening for sickle cell disease is not yet established in Namibia. Sick children present to referral hospitals with SCD related complications prior to diagnosis. Birth prevalence of sickle cell disease and sickle cell trait have not been documented in Namibia. The aim of the study was to determine the birth prevalence of sickle cell disease and sickle cell trait using the point of care test HemotypeSC™. Haemoglobin AA was considered normal, HbSS, HbC (HbSC), sickle cell disease whilst heterozygous for HbS/ HbC, HbAS / HbAC sickle cell trait. This study was the first in Namibia to carry out NBS for sickle cell disease and first to use the point of care test HemotypeSC™. In addition the study will guide policy on the need to introduce SCD, NBS in Namibia as recommended by the World Health Organisation (WHO) African Region strategy which provides a set of public health interventions to reduce the burden of SCD in African. The strategy focuses on improved awareness, disease prevention and early detection ( 37 ). Methods Design and study setting A descriptive cross sectional study was conducted between February and March 2023 at Rundu Intermediate hospital postnatal ward in Kavango East Region, Rundu Namibia. Rundu Intermediate hospital is the regional referral hospital for Kavango region and caters for approximately 237779 people according to the 2016 Inter-Census Demographic Survey (NIDS) ( 38 ). On average 500 to 800 babies are born at Rundu intermediate hospital each month. Rundu is in the Northern part of Namibia an area of high malaria burden making it an area of interest for sickle cell disease and or trait. Additionally, it is close to the Angolan border, a country considered to be sickle cell disease belt and migrants cross from one country to the other with possible intermarriages. Characteristics of participants The study participants were term newborn babies within 72 hours of birth whose mothers gave written consent to participate in the study and delivered at Rundu Intermediate hospital during the study period. All well term newborn babies who were delivered at Rundu Intermediate hospital were included in the study. Term babies who were ill or had congenital malformations were excluded from the study. Sample size determination The sample size for this study was 201. This was determined using the Dobson formula ( 39 ) below as follows: \(n={\left(\frac{{Z}_{\alpha /2}}{d}\right)}^{2}p\left(1-p\right)\) , were \({\varvec{Z}}_{\varvec{\alpha }/2}\) is the standard normal value corresponding to the desired level of confidence (95%) d is the maximum allowable error, (0.05) or 5% (width of the confidence intervals) p is the estimated prevalence sickle cell trait or sickle cell disease in newborn babies. The calculated sample size was 201 participants based on a study in Zambia which found a prevalence ( p) of sickle cell trait of 15.5%. The precision for the sample size was 5%. The prevalence of sickle cell disease used to calculate sample size was 3.4% giving a sample size of 50. Therefore the higher sample size of 201 was then used for the study. Sampling method The study site was selected using purposive sampling as Rundu is a malaria prone region which provides selective advantage to sickle cell trait. The selection of participants was based on a simple random sampling method approach, to ensure the sample’s representativeness. Health education on SCD and SCT genetics, long-term complications and benefits of newborn screening was provided to the mothers prior to recruitment to the study. Haemoglobin determination with HemotypeSC ™ Point of Care Test All well term newborn babies within 72 hours of birth whose mothers gave consent were screened for sickle cell disease and sickle cell trait using the point of care test HemotypeSC ™ (Silver Lake Research, Azusa, CA, USA). Researchers placed about 6 drops of water in a plain test tube prior to the point of care test. This was followed by collection of about 1 u l of blood from heel prick onto a blood collecting strip (blue: Fig. 1 below) for HemoType SC ™ . The blood collection strip was then placed in the test tube, and the tube was swirled until a pink colour was obtained. A test strip for the haemoglobin (red: Fig. 1 below) was then placed in the test tube and left on the bench for 10 minutes before reading. After 10 minutes the haemoglobin test strip was removed from the tube and read according to the manufacturer’s instructions. Absence of a line represented the type of haemoglobin the participant had. Results were interpreted as HbAA, HbAS, HbAC, HbSS, HbSC, HbCC, or invalid. HbAA was the normal hemoglobin, HbAS/ HbAC reported as sickle cell trait and HbSS, HbCC, HbSC as sickle cell disease. The result was entered on each infant’s questionnaire at the time of interpreting the result. A photo of each test strip including the study ID of the infant was taken as a backup. The results of the Hb type were communicated immediately and those with abnormal results had contacts collected and referred to the Paediatric Outpatient Clinic for further follow up by the resident paediatrician. Statistical analysis Data was anonymized before being analysed with Statistical Package for Social Sciences (SPSS) version 29. Descriptive statistics was used to describe sociodemographic data as well as haemoglobin phenotypes. We calculated the proportion of newborn babies with sickle cell disease (HbSS) or HbSC, sickle cell trait HbAS or HbAC), and normal haemoglobin (HbAA). Results The results of the study provide insight into the birth prevalence of sickle cell disease and sickle cell trait in newborn based in Namibia. The flow diagram below (Fig. 2 ) shows the patient flow during the study period. Demographic characteristics of the Study participants Two hundred and two participants were recruited into the study between 21 February and 23 March 2023 on Sundays through Fridays. Of all the participants, 105 (52%) were females and 97(48%) males (Table 1 ). The median age of the participants was 23 hours interquartile range (IQR), (11–33 hours) with the age range of 2–98 hours. Mothers had median number of 3 children IQR (2–4 children) with the number ranging from1 to 8 children. All the babies recruited were term with the gestational age ranging from 37–42 weeks and a median gestation age of 38 weeks, IQR (37–40 weeks). The lightest participant weighed 2.0 kg, with heaviest weighing 4.63kg. The median birth weight was 3.1kg, IQR (2.8–3.4 kilograms. In terms of birth length the median was 50 centimeters IQR (49–52), with shortest participant being 41cm and tallest 58 cm. The head circumference ranged from 34-39cm, with median head circumference of 34cm and IQR (34-35cm). Table 1 Demographic Characteristics of Study participants Variable Frequency (n = 202) Percentage (%) Sex Male Female 97 105 48 52 Maternal level of Education None Primary Secondary Tertiary 5 35 155 7 2.5 17.3 76.7 3.5 Socio-economic status Low Middle 192 10 95 5 Region of Origin Kavango East Kavango West Ohangwena Other 198 1 1 1* 98.0 1.0 0.5 0.5 Mother’s HIV status Negative Positive Unknown 166 31 5 82.2 15.3 2.5 * Other: Angola Hemoglobin type of the study participants The distribution of hemoglobin types identified by HemotypeSC ™ was distributed as shown in Fig. 3 . One hundred and eighty three (183), (90.6%) participants had normal haemoglobin (HbAA) and 19 (9.4%) had sickle cell trait (HbAS). No participant had sickle cell disease (HbSS/HbCC/HbSC) or heterozygous HbAC. Discussion Birth prevalence of sickle cell disease or sickle cell trait varies across different countries in sub-Saharan Africa. Our study is the first in Namibia to carry out birth prevalence for sickle cell disease and sickle cell trait. A high birth prevalence of sickle cell trait (9.4%) was reported. However no participant had sickle cell disease. The findings are similar to a study by Munyanganizi in Rwanda were SCT was found in 2.7% of participants and 0% sickle cell disease from a sample size of 987 participants ( 42 ). The study by Munyanganizi however, used cord blood samples and isoelectric focusing for screening. Similar studies which used HemoTypeSC as the primary screening method in some parts of Africa had sickle cell disease prevalence ranging from 1.1 to 3.9%, with the prevalence of sickle cell trait of 20.6 to as high as 31.6% ( 26 , 43 , 44 ). In these studies confirmatory test were laboratory based and they showed a high sensitivity of HemoType SC, point of care test. Studies which validated the, HemoTypeSC accuracy reported a sensitivity of 94.4 to 100% and specificity of 99.9 to 100% in multicenter studies conducted in Ghana, Mortinique and USA and a separate study in Nigeria ( 26 , 29 ). Therefore our study findings may be a true representation of the actual hemoglobin types found in the participants considering the high sensitivity of the test. Considering that Namibia is a vast country with centralized laboratories which are a distant from health facilities and limited laboratory personnel, the HemotypeSC is a potential tool for not only for newborn screening sickle cell disease but also a cheap test for diagnosing SCD in symptomatic patients; children and adults alike. Health personnel can be trained at the low level facilities and perform the test and provide results in the same sitting rather. The current test for diagnosing symptomatic patients, hemoglobin electrophoresis has a turnaround time of between 7 to 14 days. The population which is likely to have sickle cell disease (HbSS) can be estimated using the Hardy-Weinberg equilibrium, mode; theorem or law which state that the allele and genotype frequencies in a population will remain constant from generation to generation in the absence of the evolutionary influences such as genetic drift, natural selection and many other factors ( 45 ). The simple formula; p2 + 2pq + q2 = 1 and p + q = 1 where: p = frequency of the dominant allele in the population = AA = 90.6% q = frequency of the recessive allele in the population = s p2 = percentage of homozygous dominant individuals q2 = percentage of homozygous recessive individuals = ss 2pq = percentage of heterozygous individuals = = As = 9.4% To calculate the value of q, p = 0.906 q = 1-p q = 1-0.906 q = 0.094 Punnet square frequencies table A(p) s(q) A(p) AA(p 2 ) As(pq) s(q) As(pq) ss(q 2 ) The estimate of the homozygous recessive individuals with ss for sickle cell disease = 0.094 2 = 0.008836 = as percentage 0.88%. An estimated population with sickle cell disease from the equation is therefore 0.88%. Using this formula therefore it can be estimated that approximately 2092 people are likely to have sickle cell disease in Kavango region which has a total population 237779 as per the last census ( 38 ). Conclusion In conclusion the research serves as a foundation for future efforts to combat sickle cell disease in Namibia. There was a high prevalence of sickle cell trait and the estimated sickle cell disease birth prevalence moderate. It underscores the importance of early screening accurate diagnostic tools which are affordable and easy to use. The HemoTypeSC is an inexpensive test, accurate, and rapid point-of‐care test that can be used in resource‐limited regions to provide timely diagnosis and support newborn screening programs. Abbreviations DBS Dried blood spots DNA Deoxyribonucleic acid Hb Haemoglobin HbAA Haemoglobin AA HbCC Haemoglobin CC HbS Haemoglobin S HbSS Haemoglobin SS HPLC High performance liquid chromatography IEF Isoelectric focusing NBS Newborn screening NIDS Inter-Census Demographic Survey PCR Polymerase Chain Reaction POCT Point of care test REDCap Research Electronic Data Capture RFLP Restriction Fragment Length Polymorphism SCD Sickle cell disease SPSS Statistical Package for Social Sciences WHO World Health Organisation Declarations Ethics approval and consent to participate Written informed consent was obtained from mothers of the newborn babies. The Institutional Review Boards of the Ministry of Health and Social Services (Ref: 22/3/1/2) and the University of Namibia Ethics Committee (REC) (Ref: SOM04/2023) approved the study. Consent for publication was granted by the Ministry of Health and Social Services Ethics Committee (Ref: 22/4/6/2). Consent for publication No individual images or pictures are included in the report . Availability of data and material Data sets for this study are published in Zenodo and can be accessed openly via https://doi.org/10.5281/zenodo.826621 Competing interests The authors declare that they do not have competing interests. Funding This study was fully funded through the University of Namibia Faculty of Health Sciences and Veterinary Medicine Seed Corn grant. Authors’ contributions RMM conceived the study, participated in the design, collected and analysed data, and drafted manuscript. PK and JM participated in the study design, manuscript critically revised the manuscript. All authors read and approved the final manuscript. Acknowledgements The authors would like to thank the participants and their caregivers for participating in the study. We would like to thank all the research assistants who helped us with sample collection. Our great felt gratitude goes to the statistician for helping with data analysis. We would also like to thank the University of Namibia, School of Medicine, Department of Maternal & Child Health, and Division of Pediatrics for support given during the study period. We would also like to extend our gratitude to the Executive Dean of the Faculty of Health Sciences and Veterinary Medicine for providing funding through the seed Corn grant of the University of Namibia (0645 /2901) Authors' information (optional) RMM Consultant Paediatrician, Lecturer , University of Namibia, Faculty of Health Sciences & Veterinary Medicine, School of Medicine, Department of Maternal & Child Health, Division of Paediatrics, MBChB, MMed Paeds. 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Accessed 28 April 2023. 2016. Chunda-Liyoka C, Kumar AA, Sambo P, Lubinda F, Nchimba L, Humpton T, et al. Application of a public health strategy to large-scale point-of-care screening for sickle cell disease in rural sub-Saharan Africa. Blood Adv. 2018;2(Supplement1):1–3. Kasai E, Boemer F, Marini RD, Kadima J, Agasa S, Dauly N, et al. Systematic Screening of Neonatal Sickle Cell Disease with HemoTypeSC TM Kit-Test: Case Study and Literature Review. Open J Blood Dis. 2020;10:12–21. Dexter D, McGann PT. Saving lives through early diagnosis: the promise and role of point of care testing for sickle cell disease. Br J Haematol. 2022;196(1):63–9. Munyanganizi R, Cotton F, Vertongen F, Gulbis B. Red blood cell disorders in Rwandese neonates: screening for sickle cell disease and glucose-6-phosphate dehydrogenase deficiency. J Med Screen. 2006;13(3):129–31. Odunvbun ME, Okolo AA, Rahimy CM. Newborn screening for sickle cell disease in a Nigerian hospital. Public Health. 2008;122(10):1111–6. Eastburg L, Peckham A, Kawira E, Chirangi B, Adler D, Akungo BD, et al. Extremely high birth prevalence of sickle cell disease in rural Tanzania. Pediatr Blood Cancer. 2020;67(11):e28620. K-State PL. PRINCIPLES OF BIOLOGY2000. Additional Declarations No competing interests reported. Cite Share Download PDF Status: Published Journal Publication published 10 May, 2024 Read the published version in BMC Pediatrics → Version 1 posted Editorial decision: Revision requested 08 Mar, 2024 Reviews received at journal 17 Feb, 2024 Reviewers agreed at journal 02 Jan, 2024 Reviews received at journal 27 Dec, 2023 Reviewers agreed at journal 27 Dec, 2023 Reviewers invited by journal 26 Dec, 2023 Editor assigned by journal 26 Dec, 2023 Editor invited by journal 14 Dec, 2023 Submission checks completed at journal 14 Dec, 2023 First submitted to journal 14 Dec, 2023 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-3753291","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":260525898,"identity":"faa2d64a-0dd0-4778-be44-24040d6da409","order_by":0,"name":"Runyararo Mashingaidze Mano","email":"data:image/png;base64,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","orcid":"","institution":"University of Namibia","correspondingAuthor":true,"submittingAuthor":false,"prefix":"","firstName":"Runyararo","middleName":"Mashingaidze","lastName":"Mano","suffix":""},{"id":260525899,"identity":"7e0369ef-c608-4f8d-92ec-4d1d6da28172","order_by":1,"name":"Patience Kuona","email":"","orcid":"","institution":"University of Zimbabwe","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Patience","middleName":"","lastName":"Kuona","suffix":""},{"id":260525901,"identity":"81d1a961-c755-48bf-8739-d830557c35cf","order_by":2,"name":"Jane Masiiwa Misihairabgwi","email":"","orcid":"","institution":"University of Namibia","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Jane","middleName":"Masiiwa","lastName":"Misihairabgwi","suffix":""}],"badges":[],"createdAt":"2023-12-14 11:44:18","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-3753291/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-3753291/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s12887-024-04805-z","type":"published","date":"2024-05-10T21:18:02+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":48483992,"identity":"44f373b1-6b24-40c5-a9f5-e9786fc01ca3","added_by":"auto","created_at":"2023-12-19 19:18:08","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":545219,"visible":true,"origin":"","legend":"\u003cp\u003eStep by step HemotypeSC\u003csup\u003eTM\u003c/sup\u003e point of care test for sickle cell disease (40, 41).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStatistical analysis\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-3753291/v1/79864fa6527dfc2edc77c347.png"},{"id":48483991,"identity":"d899b197-4a25-4909-aeda-e68a817cda25","added_by":"auto","created_at":"2023-12-19 19:18:08","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":9066,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eFlow diagram showing patient flow in February and March 2023 at Rundu hospital\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDemographic characteristics of the Study participants\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-3753291/v1/5c390566b255f14da883e652.png"},{"id":48483993,"identity":"e2cdde8c-282b-4587-bd0b-4abb4d4a5c81","added_by":"auto","created_at":"2023-12-19 19:18:08","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":86338,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eBirth prevalence of haemoglobinopathies in 202 neonates screened from 21 February to 23 March 2023 at Rundu Intermediate Hospital, Kavango region, Namibia\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"3.png","url":"https://assets-eu.researchsquare.com/files/rs-3753291/v1/0c20f6e011f1f0fea11c6456.png"},{"id":56488577,"identity":"3531f4ae-0e9b-40ca-9f4f-acfeda95282d","added_by":"auto","created_at":"2024-05-14 21:32:47","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1132774,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-3753291/v1/0d30d8ad-e73b-40ba-8347-55d5b97ead44.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Determination of birth prevalence of sickle cell disease using point of care test HemoTypeSC TM at Rundu hospital, Namibia","fulltext":[{"header":"Background","content":"\u003cp\u003eSickle cell disease (SCD), a non-communicable disease, has its highest burden in Sub Saharan Africa and is the most frequent genetic haemoglobinopathy, with over 300 000 children born with the disease annually and this number is expected to increase to 400 000 by 2050 (\u003cspan additionalcitationids=\"CR2\" citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e). The majority of these children (50\u0026ndash;90%), die before their 5th birthday with approximately 150,000\u0026ndash;300,000 annual SCD child deaths in Africa ,which can potentially accounting for 5\u0026ndash;10% of the region\u0026rsquo;s total child mortality (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e, \u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e). Nearly 90% of SCD patients live in 3 countries, Nigeria, India and Democratic Republic of Congo. In these countries nearly 2% of the population have SCD with a carrier rate, sickle cell trait, ranging from 10\u0026ndash;30% (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e). However, it has been found recently that the distribution of all the hemoglobin disorders is extremely diverse within different countries, even within small geographical distances (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eSickle cell disease (SCD) is a genetic autosomal recessive disorder which results from substitution of valine for glutamine at position 6 of the beta chain haemoglobin. The haemoglobin (HbSS) tetramer that results from the substitution has alpha 2 and beta S2, is poorly soluble and rigid when deoxygenated resulting in vaso-occlusion which in turn causes several complications (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e). Moreover, there are different forms of sickle cell disease which include HbSS, HbSC, HbS beta thalassaemia, HbSE, and HbSD and many more and it occurs throughout sub-Saharan Africa, and in small pockets in the Mediterranean region, the Middle East and Indian subcontinent (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e). The HbSC disease is restricted to parts of west and North Africa, HbS thalassemia is localised in parts in sub-Saharan Africa, some parts of the Middle East and India subcontinent. Additionally, HbSE occur commonly in India, Bangladesh, Myammer and east and southeast Asia (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eAmong SCD variants, HbSS is the commonest in the sub-Saharan region and is associated with severe forms of complications in comparison with the other variants. These complications include but are ,not limited to priapism, pulmonary emboli, osteonecrosis, and ultimately damages every organ system including the spleen, retinae, kidneys and liver(\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eSickle cell trait the heterozygous form of HbS is the carrier state for sickle cell haemoglobin. These individuals inherit HbS/C from one parent and HbA from the other parent making them heterozygous (HbAS) or HbAC. More than 100\u0026nbsp;million or about 5% of the world population have the sickle cell trait (SCT) (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e). Most people with sickle cell trait live asymptomatically. Despite SCT being perceived as an asymptomatic condition several case reports and reviews reported an increased incidence of renal medullary carcinoma among young patients with SCT with the age wide from 9 to 69 years (\u003cspan additionalcitationids=\"CR13\" citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e). Other forms of SCT include HbAC, and HbAE although these are rare forms (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe gene for sickle hemoglobin (HbS) is a prime example of natural selection. It is generally believed that its current prevalence in many tropical populations reflects selection for the carrier form (sickle cell trait (HbAS) through a survival advantage against death from malaria (\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e). A study by Williams et al, 2005 (\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e) showed that HbAS had no effect on the prevalence of symptomless parasitaemia but was 50% protective against mild clinical malaria, 75% protective against admission to the hospital for malaria, and almost 90% protective against severe or complicated malaria.\u003c/p\u003e \u003cp\u003eMalaria remains a major public health problem in Namibia mostly in Kavango East and West, Ohangwena and Zambezi regions. The 4 regions accounted for 96% of cases with Kavango East and West accounting for 81%, Zambezi 10% and Ohangwena 5% according to a recently published study (2023) by Katale and Gemechu(\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eEarly detection of sickle cell disease or trait is imperative to the long term outcome as treatment can be initiated early. In developed countries, newborn screening (NBS) has been shown to improve survival of children with sickle cell disease with under 5 childhood mortality reduced 10 fold due to interventions done before development of complications (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eOver the years, several techniques have been employed to diagnose and monitor SCD. High performance liquid chromatography (HPLC and isoelectric focusing( IEF) are the two main laboratory techniques for haemoglobinopathy screening currently suitable for routine use and have been used in developed countries and several studies in Africa (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e). Molecular genetic tests are considered the gold standard tests as they target the affected genes and are able to distinguish the different mutations (\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e). These include Restriction Fragment Polymorphism (RFLP) partial restriction of deoxyribonucleic acid (DNA), Real-time polymerase chain reaction (PCR) (\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e) and DNA sequencing which is the most expensive molecular method compared to RFLP and PCR\u003c/p\u003e \u003cp\u003ebecause of reagents, instrumentation, personnel and review time required for analysis, but it provides the most comprehensive data for beta-globin gene (\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e). Point of care tests (POCT), SCD screening methods validated in developing countries, are easier to perform and require less qualified personnel with results available within a short period of time(\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e). These tests provide results within a short period of time. Sickle cell SCAN\u0026trade;, a lateral flow assay reliably identifies HbA, HbS, and HbC, easily performed by non-skilled personnel, easily interpreted, rapid test at the point of care (\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e). This test detected the correct A, S, and C presence with an overall diagnostic accuracy of 99% at the bedside (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e). However it is relatively more expensive than other POCTs.\u003c/p\u003e \u003cp\u003eOther novel POCTs include Heme Cheap, which is reliable, able to distinguish most types of sickle cell disease including compound heterozygotes. However, it requires skilled interpretation, web-based, automated and this is out of reach of most resource limited regions (\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e). Additionally, Aqueous multiphase System (AMPS) (density based test to separate Hb in different density fluids) and Paper based Sickle test (microfluid assessment) are inexpensive and require non-skilled personnel. However, the interpretation maybe difficult and the later requires a scanner for interpretation (\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e, \u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eLately, HemoTypeSC\u0026trade;, a POCT a monoclonal antibody based which targets Hb A, S, and C but not Hb F is one of the newest techniques yield results in 10 minutes (\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e, \u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e). Multiple studies found HemoTypeSC\u0026trade; to have a sensitivity and specificity of over 98% compared to the gold standard methods of HPLC and IEF (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e, \u003cspan additionalcitationids=\"CR27 CR28 CR29 CR30\" citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e). Success in implementation of newborn screening programs include health education of stake holders (\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e). The HemotypeSC point-of-care testing device has shown high sensitivity and specificity for diagnosing sickle cell disease (SCD) in various studies. A study by Olatunya et al, 2021 found that HemotypeSC had perfect concordance with PCR and 100% accuracy in diagnosing SCD, while Nnodu et al, 2019 reported a sensitivity of 93.4% and a specificity of 99.9% for SCD (\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e, \u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e). In addition, Okeke, 2022 further demonstrated the feasibility of using dried blood spots with HemotypeSC, with a sensitivity and specificity of 100% compared to the standard test (\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e). A further study by Adegoke et al 2022,(\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e) also found high sensitivity of HemotypeSC when compared to alkaline cellulose acetate hemoglobin electrophoresis. These findings collectively suggest that HemotypeSC is a reliable and accurate tool for SCD diagnosis. Although other POCT test such as Sickle SCAN have been validated in some parts, Hemotype SC has shown to be cheaper and easy to use (\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e, \u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eNew born screening for sickle cell disease is not yet established in Namibia. Sick children present to referral hospitals with SCD related complications prior to diagnosis. Birth prevalence of sickle cell disease and sickle cell trait have not been documented in Namibia.\u003c/p\u003e \u003cp\u003eThe aim of the study was to determine the birth prevalence of sickle cell disease and sickle cell trait using the point of care test HemotypeSC\u0026trade;. Haemoglobin AA was considered normal, HbSS, HbC (HbSC), sickle cell disease whilst heterozygous for HbS/ HbC, HbAS / HbAC sickle cell trait. This study was the first in Namibia to carry out NBS for sickle cell disease and first to use the point of care test HemotypeSC\u0026trade;. In addition the study will guide policy on the need to introduce SCD, NBS in Namibia as recommended by the World Health Organisation (WHO) African Region strategy which provides a set of public health interventions to reduce the burden of SCD in African. The strategy focuses on improved awareness, disease prevention and early detection (\u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e).\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eDesign and study setting\u003c/h2\u003e \u003cp\u003e\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003eA descriptive cross sectional study was conducted between February and March 2023 at Rundu Intermediate hospital postnatal ward in Kavango East Region, Rundu Namibia. Rundu Intermediate hospital is the regional referral hospital for Kavango region and caters for approximately 237779 people according to the 2016 Inter-Census Demographic Survey (NIDS) (\u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e). On average 500 to 800 babies are born at Rundu intermediate hospital each month. Rundu is in the Northern part of Namibia an area of high malaria burden making it an area of interest for sickle cell disease and or trait. Additionally, it is close to the Angolan border, a country considered to be sickle cell disease belt and migrants cross from one country to the other with possible intermarriages.\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eCharacteristics of participants\u003c/h2\u003e \u003cp\u003eThe study participants were term newborn babies within 72 hours of birth whose mothers gave written consent to participate in the study and delivered at Rundu Intermediate hospital during the study period. All well term newborn babies who were delivered at Rundu Intermediate hospital were included in the study. Term babies who were ill or had congenital malformations were excluded from the study.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eSample size determination\u003c/h2\u003e \u003cp\u003eThe sample size for this study was 201. This was determined using the Dobson formula (\u003cspan citationid=\"CR39\" class=\"CitationRef\"\u003e39\u003c/span\u003e) below as follows:\u003cspan class=\"InlineEquation\"\u003e\u003cspan class=\"mathinline\"\u003e\\(n={\\left(\\frac{{Z}_{\\alpha /2}}{d}\\right)}^{2}p\\left(1-p\\right)\\)\u003c/span\u003e\u003c/span\u003e\u003c/p\u003e \u003cp\u003e, were\u003cspan class=\"InlineEquation\"\u003e\u003cspan class=\"mathinline\"\u003e\\({\\varvec{Z}}_{\\varvec{\\alpha }/2}\\)\u003c/span\u003e\u003c/span\u003e is the standard normal value corresponding to the desired level of confidence (95%)\u003c/p\u003e \u003cp\u003e \u003cb\u003ed\u003c/b\u003e is the maximum allowable error, (0.05) or 5% (width of the confidence intervals)\u003c/p\u003e \u003cp\u003e \u003cb\u003ep\u003c/b\u003e is the estimated prevalence sickle cell trait or sickle cell disease in newborn babies. The calculated sample size was \u003cb\u003e201\u003c/b\u003e participants based on a study in Zambia which found a prevalence (\u003cb\u003ep)\u003c/b\u003e of sickle cell trait of 15.5%. The precision for the sample size was 5%. The prevalence of sickle cell disease used to calculate sample size was 3.4% giving a sample size of 50. Therefore the higher sample size of 201 was then used for the study.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eSampling method\u003c/h2\u003e \u003cp\u003eThe study site was selected using purposive sampling as Rundu is a malaria prone region which provides selective advantage to sickle cell trait. The selection of participants was based on a simple random sampling method approach, to ensure the sample\u0026rsquo;s representativeness. Health education on SCD and SCT genetics, long-term complications and benefits of newborn screening was provided to the mothers prior to recruitment to the study.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003eHaemoglobin determination with HemotypeSC\u003csup\u003e\u0026trade;\u003c/sup\u003e Point of Care Test\u003c/h2\u003e \u003cp\u003e \u003cdiv class=\"BlockQuote\"\u003e \u003cp\u003eAll well term newborn babies within 72 hours of birth whose mothers gave consent were screened for sickle cell disease and sickle cell trait using the point of care test HemotypeSC\u003csup\u003e\u0026trade;\u003c/sup\u003e (Silver Lake Research, Azusa, CA, USA). Researchers placed about 6 drops of water in a plain test tube prior to the point of care test. This was followed by collection of about 1\u003cem\u003eu\u003c/em\u003el of blood from heel prick onto a blood collecting strip (blue: Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e below) for HemoType SC\u003csup\u003e\u0026trade;\u003c/sup\u003e. The blood collection strip was then placed in the test tube, and the tube was swirled until a pink colour was obtained. A test strip for the haemoglobin (red: Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e below) was then placed in the test tube and left on the bench for 10 minutes before reading.\u003c/p\u003e \u003cp\u003eAfter 10 minutes the haemoglobin test strip was removed from the tube and read according to the manufacturer\u0026rsquo;s instructions. Absence of a line represented the type of haemoglobin the participant had. Results were interpreted as HbAA, HbAS, HbAC, HbSS, HbSC, HbCC, or invalid. HbAA was the normal hemoglobin, HbAS/ HbAC reported as sickle cell trait and HbSS, HbCC, HbSC as sickle cell disease. The result was entered on each infant\u0026rsquo;s questionnaire at the time of interpreting the result. A photo of each test strip including the study ID of the infant was taken as a backup. The results of the Hb type were communicated immediately and those with abnormal results had contacts collected and referred to the Paediatric Outpatient Clinic for further follow up by the resident paediatrician.\u003c/p\u003e \u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003e \u003cdiv class=\"BlockQuote\"\u003e \u003cp\u003eData was anonymized before being analysed with Statistical Package for Social Sciences (SPSS) version 29. Descriptive statistics was used to describe sociodemographic data as well as haemoglobin phenotypes. We calculated the proportion of newborn babies with sickle cell disease (HbSS) or HbSC, sickle cell trait HbAS or HbAC), and normal haemoglobin (HbAA).\u003c/p\u003e \u003c/div\u003e \u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003e \u003cdiv class=\"BlockQuote\"\u003e \u003cp\u003eThe results of the study provide insight into the birth prevalence of sickle cell disease and sickle cell trait in newborn based in Namibia. The flow diagram below (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e) shows the patient flow during the study period.\u003c/p\u003e \u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cdiv id=\"Sec10\" class=\"Section2\"\u003e \u003ch2\u003eDemographic characteristics of the Study participants\u003c/h2\u003e \u003cp\u003e \u003cdiv class=\"BlockQuote\"\u003e \u003cp\u003eTwo hundred and two participants were recruited into the study between 21 February and 23 March 2023 on Sundays through Fridays. Of all the participants, 105 (52%) were females and 97(48%) males (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). The median age of the participants was 23 hours interquartile range (IQR), (11\u0026ndash;33 hours) with the age range of 2\u0026ndash;98 hours. Mothers had median number of 3 children IQR (2\u0026ndash;4 children) with the number ranging from1 to 8 children. All the babies recruited were term with the gestational age ranging from 37\u0026ndash;42 weeks and a median gestation age of 38 weeks, IQR (37\u0026ndash;40 weeks). The lightest participant weighed 2.0 kg, with heaviest weighing 4.63kg. The median birth weight was 3.1kg, IQR (2.8\u0026ndash;3.4 kilograms. In terms of birth length the median was 50 centimeters IQR (49\u0026ndash;52), with shortest participant being 41cm and tallest 58 cm. The head circumference ranged from 34-39cm, with median head circumference of 34cm and IQR (34-35cm).\u003c/p\u003e \u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eDemographic Characteristics of Study participants\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eVariable\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eFrequency (n\u0026thinsp;=\u0026thinsp;202)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003ePercentage (%)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSex\u003c/p\u003e \u003cp\u003eMale\u003c/p\u003e \u003cp\u003eFemale\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003e97\u003c/p\u003e \u003cp\u003e105\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e48\u003c/p\u003e \u003cp\u003e52\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMaternal level of Education\u003c/p\u003e \u003cp\u003eNone\u003c/p\u003e \u003cp\u003ePrimary\u003c/p\u003e \u003cp\u003eSecondary\u003c/p\u003e \u003cp\u003eTertiary\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5\u003c/p\u003e \u003cp\u003e35\u003c/p\u003e \u003cp\u003e155\u003c/p\u003e \u003cp\u003e7\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2.5\u003c/p\u003e \u003cp\u003e17.3\u003c/p\u003e \u003cp\u003e76.7\u003c/p\u003e \u003cp\u003e3.5\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eSocio-economic status\u003c/b\u003e\u003c/p\u003e \u003cp\u003eLow\u003c/p\u003e \u003cp\u003eMiddle\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e192\u003c/p\u003e \u003cp\u003e10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e95\u003c/p\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eRegion of Origin\u003c/b\u003e\u003c/p\u003e \u003cp\u003eKavango East\u003c/p\u003e \u003cp\u003eKavango West\u003c/p\u003e \u003cp\u003eOhangwena\u003c/p\u003e \u003cp\u003eOther\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e198\u003c/p\u003e \u003cp\u003e1\u003c/p\u003e \u003cp\u003e1\u003c/p\u003e \u003cp\u003e1*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e98.0\u003c/p\u003e \u003cp\u003e1.0\u003c/p\u003e \u003cp\u003e0.5\u003c/p\u003e \u003cp\u003e0.5\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eMother\u0026rsquo;s HIV status\u003c/b\u003e\u003c/p\u003e \u003cp\u003eNegative\u003c/p\u003e \u003cp\u003ePositive\u003c/p\u003e \u003cp\u003eUnknown\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e166\u003c/p\u003e \u003cp\u003e31\u003c/p\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e82.2\u003c/p\u003e \u003cp\u003e15.3\u003c/p\u003e \u003cp\u003e2.5\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"3\"\u003e\u003csup\u003e*\u003c/sup\u003eOther: Angola\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eHemoglobin type of the study participants\u003c/h2\u003e \u003cp\u003e \u003cdiv class=\"BlockQuote\"\u003e \u003cp\u003eThe distribution of hemoglobin types identified by HemotypeSC\u003csup\u003e\u0026trade;\u003c/sup\u003e was distributed as shown in Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003e. One hundred and eighty three (183), (90.6%) participants had normal haemoglobin (HbAA) and 19 (9.4%) had sickle cell trait (HbAS). No participant had sickle cell disease (HbSS/HbCC/HbSC) or heterozygous HbAC.\u003c/p\u003e \u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003e \u003cdiv class=\"BlockQuote\"\u003e \u003cp\u003eBirth prevalence of sickle cell disease or sickle cell trait varies across different countries in sub-Saharan Africa. Our study is the first in Namibia to carry out birth prevalence for sickle cell disease and sickle cell trait. A high birth prevalence of sickle cell trait (9.4%) was reported. However no participant had sickle cell disease. The findings are similar to a study by Munyanganizi in Rwanda were SCT was found in 2.7% of participants and 0% sickle cell disease from a sample size of 987 participants (\u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e42\u003c/span\u003e). The study by Munyanganizi however, used cord blood samples and isoelectric focusing for screening.\u003c/p\u003e \u003c/div\u003e \u003c/p\u003e \u003cp\u003eSimilar studies which used HemoTypeSC as the primary screening method in some parts of Africa had sickle cell disease prevalence ranging from 1.1 to 3.9%, with the prevalence of sickle cell trait of 20.6 to as high as 31.6% (\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e, \u003cspan citationid=\"CR43\" class=\"CitationRef\"\u003e43\u003c/span\u003e, \u003cspan citationid=\"CR44\" class=\"CitationRef\"\u003e44\u003c/span\u003e). In these studies confirmatory test were laboratory based and they showed a high sensitivity of HemoType SC, point of care test.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003eStudies which validated the, HemoTypeSC accuracy reported a sensitivity of 94.4 to 100% and specificity of 99.9 to 100% in multicenter studies conducted in Ghana, Mortinique and USA and a separate study in Nigeria (\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e, \u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e). Therefore our study findings may be a true representation of the actual hemoglobin types found in the participants considering the high sensitivity of the test. Considering that Namibia is a vast country with centralized laboratories which are a distant from health facilities and limited laboratory personnel, the HemotypeSC is a potential tool for not only for newborn screening sickle cell disease but also a cheap test for diagnosing SCD in symptomatic patients; children and adults alike. Health personnel can be trained at the low level facilities and perform the test and provide results in the same sitting rather. The current test for diagnosing symptomatic patients, hemoglobin electrophoresis has a turnaround time of between 7 to 14 days.\u003c/p\u003e\u003cp\u003eThe population which is likely to have sickle cell disease (HbSS) can be estimated using the Hardy-Weinberg equilibrium, mode; theorem or law which state that the allele and genotype frequencies in a population will remain constant from generation to generation in the absence of the evolutionary influences such as genetic drift, natural selection and many other factors (\u003cspan citationid=\"CR45\" class=\"CitationRef\"\u003e45\u003c/span\u003e). The simple formula; p2\u0026thinsp;+\u0026thinsp;2pq\u0026thinsp;+\u0026thinsp;q2\u0026thinsp;=\u0026thinsp;1 and p\u0026thinsp;+\u0026thinsp;q\u0026thinsp;=\u0026thinsp;1 where:\u003c/p\u003e\u003cp\u003ep\u0026thinsp;=\u0026thinsp;frequency of the dominant allele in the population\u0026thinsp;=\u0026thinsp;AA\u0026thinsp;=\u0026thinsp;90.6%\u003c/p\u003e\u003cp\u003eq\u0026thinsp;=\u0026thinsp;frequency of the recessive allele in the population\u0026thinsp;=\u0026thinsp;s\u003c/p\u003e\u003cp\u003ep2\u0026thinsp;=\u0026thinsp;percentage of homozygous dominant individuals\u003c/p\u003e\u003cp\u003eq2\u0026thinsp;=\u0026thinsp;percentage of homozygous recessive individuals\u0026thinsp;=\u0026thinsp;ss\u003c/p\u003e\u003cp\u003e2pq\u0026thinsp;=\u0026thinsp;percentage of heterozygous individuals\u0026thinsp;=\u0026thinsp;=\u0026thinsp;As =\u0026thinsp;9.4%\u003c/p\u003e\u003cp\u003eTo calculate the value of q,\u003c/p\u003e\u003cp\u003ep\u0026thinsp;=\u0026thinsp;0.906\u003c/p\u003e\u003cp\u003eq\u0026thinsp;=\u0026thinsp;1-p\u003c/p\u003e\u003cp\u003eq\u0026thinsp;=\u0026thinsp;1-0.906\u003c/p\u003e\u003cp\u003eq\u0026thinsp;=\u0026thinsp;0.094\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003ePunnet square frequencies table\u003c/h2\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"No\" id=\"Taba\" border=\"1\"\u003e \u003ccolgroup cols=\"3\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eA(p)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003es(q)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eA(p)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAA(p\u003csup\u003e2\u003c/sup\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eAs(pq)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003es(q)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAs(pq)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003ess(q\u003csup\u003e2\u003c/sup\u003e)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eThe estimate of the homozygous recessive individuals with ss for sickle cell disease\u0026thinsp;=\u0026thinsp;0.094\u003csup\u003e2\u003c/sup\u003e=\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e0.008836\u0026thinsp;=\u0026thinsp;as percentage 0.88%. An estimated population with sickle cell disease from the equation is therefore 0.88%. Using this formula therefore it can be estimated that approximately 2092 people are likely to have sickle cell disease in Kavango region which has a total population 237779 as per the last census (\u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e).\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003c/div\u003e"},{"header":"Conclusion","content":"\u003cp\u003e \u003cdiv class=\"BlockQuote\"\u003e \u003cp\u003eIn conclusion the research serves as a foundation for future efforts to combat sickle cell disease in Namibia. There was a high prevalence of sickle cell trait and the estimated sickle cell disease birth prevalence moderate. It underscores the importance of early screening accurate diagnostic tools which are affordable and easy to use. The HemoTypeSC is an inexpensive test, accurate, and rapid point-of‐care test that can be used in resource‐limited regions to provide timely diagnosis and support newborn screening programs.\u003c/p\u003e \u003c/div\u003e \u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eDBS\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Dried blood spots\u003c/p\u003e\n\u003cp\u003eDNA\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Deoxyribonucleic acid\u003c/p\u003e\n\u003cp\u003eHb \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Haemoglobin\u003c/p\u003e\n\u003cp\u003eHbAA\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Haemoglobin AA\u003c/p\u003e\n\u003cp\u003eHbCC\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Haemoglobin CC\u003c/p\u003e\n\u003cp\u003eHbS\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Haemoglobin S\u003c/p\u003e\n\u003cp\u003eHbSS\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Haemoglobin SS\u003c/p\u003e\n\u003cp\u003eHPLC\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;High performance liquid chromatography\u003c/p\u003e\n\u003cp\u003eIEF\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Isoelectric focusing\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eNBS\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp; Newborn screening\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eNIDS\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Inter-Census Demographic Survey\u0026nbsp;\u003c/p\u003e\n\u003cp\u003ePCR\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Polymerase Chain Reaction\u003c/p\u003e\n\u003cp\u003ePOCT\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp; Point of care test\u003c/p\u003e\n\u003cp\u003eREDCap\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Research Electronic Data Capture\u003c/p\u003e\n\u003cp\u003eRFLP\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Restriction Fragment Length Polymorphism\u003c/p\u003e\n\u003cp\u003eSCD\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Sickle cell disease\u003c/p\u003e\n\u003cp\u003eSPSS\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Statistical Package for Social Sciences\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eWHO \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; World Health Organisation\u0026nbsp;\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWritten informed consent was obtained from mothers of the newborn babies. The Institutional Review Boards of the Ministry of Health and Social Services (Ref: 22/3/1/2) and the University of Namibia Ethics Committee (REC) (Ref: SOM04/2023) approved the study.\u0026nbsp;Consent for publication was granted by the Ministry of Health and Social Services Ethics Committee (Ref: 22/4/6/2).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNo individual images or pictures are included in the report\u003cstrong\u003e.\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and material\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eData sets for this study are published in Zenodo and can be accessed openly via https://doi.org/10.5281/zenodo.826621\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they do not have competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study was fully funded through the University of Namibia Faculty of Health Sciences and Veterinary Medicine Seed Corn grant.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026rsquo; contributions\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eRMM conceived the study, participated in the design, collected and analysed data, and drafted manuscript. PK and JM participated in the study design, manuscript critically revised the manuscript. All authors read and approved the final manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors would like to thank the participants and their caregivers for participating in the study. We would like to thank all the research assistants who helped us with sample collection. Our great felt gratitude goes to the statistician for helping with data analysis. We would also like to thank the University of Namibia, School of Medicine, Department of Maternal \u0026amp; Child Health, and Division of Pediatrics for support given during the study period. We would also like to extend our gratitude to the Executive Dean of the Faculty of Health Sciences and Veterinary Medicine for providing funding through the seed Corn grant of the University of Namibia (0645 /2901)\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026apos; information (optional)\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eRMM Consultant Paediatrician, Lecturer , University of Namibia, \u0026nbsp;Faculty of Health Sciences \u0026amp; Veterinary Medicine, School of Medicine, Department of Maternal \u0026amp; Child Health, Division of Paediatrics, \u0026nbsp;MBChB, MMed Paeds.\u003c/p\u003e\n\u003cp\u003eKM Consultant Paediatric, Haemato-oncologist, Senior Lecture, University of Zimbabwe, Faculty of Medicine, Department of Primary Health Care, Child and Adolescent Unit, MBChB, MMed Paeds , PhD, \u0026nbsp;Cert-Haemato-Oncology,\u003c/p\u003e\n\u003cp\u003eJM Associate Professor, University of Namibia, Faculty of Health Sciences \u0026amp; Veterinary Medicine, School of Medicine, \u0026nbsp;Department of Huma, Biological and Translational Medical Sciences, BSC Hons Biochemistry, PhD Biochemistry\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003ePiel FB, Hay SI, Gupta S, Weatherall DJ, Williams TN. 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The Lancet Haematology. 2019;6(8):e393-e4. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/S2352-3026(19)30111-5 https://doi.org/10.1016/S2352-3026(19)-5\u003c/span\u003e\u003c/span\u003e. Accessed 14 March 2022.\u003c/li\u003e\n\u003cli\u003eWilliams TN. Sickle Cell Disease in Sub-Saharan Africa. Hematol Oncol Clin N Am. 2016;30(2):343\u0026ndash;58.\u003c/li\u003e\n\u003cli\u003eMartin H, Steinberg BGF, Douglas R, Higgs andDavid J. Weatherall. Disorders of Hemoglobin Genetics, Pathophysiology, and Clinical Management, pp.\u0026nbsp;587\u0026ndash;588\n\u003cdiv class=\"ExternalRefDOI\"\u003ehttps://doi.org/10.1017/CBO9780511596582.032[Opens Publisher: Cambridge University Press. 2009 Accessed 1 March 1978. 2009.\u003c/div\u003e\n\u003c/li\u003e\n\u003cli\u003eSchnog JB, Duits AJ, Muskiet FA, ten Cate H, Rojer RA, Brandjes DP. Sickle cell disease; a general overview. Neth J Med. 2004;62(10):364\u0026ndash;74.\u003c/li\u003e\n\u003cli\u003eWilliams TN, Weatherall DJ. World distribution, population genetics, and health burden of the hemoglobinopathies. Cold Spring Harb Perspect Med. 2012;2(9):a011692.\u003c/li\u003e\n\u003cli\u003eMarengo-Rowe AJ. Structure-function relations of human hemoglobins. Proc (Bayl Univ Med Cent). 2006;19(3):239\u0026ndash;45.\u003c/li\u003e\n\u003cli\u003eRegion WHOA. Sickle Cell disease. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.afro.who.int/health-topics/sickle-cell-disease\u003c/span\u003e\u003c/span\u003e. Accessed 25 April 2023. 2023.\u003c/li\u003e\n\u003cli\u003eWatanabe IC, Billis A, Guimar\u0026atilde;es MS, Alvarenga M, de Matos AC, Cardinalli IA, et al. Renal medullary carcinoma: report of seven cases from Brazil. Mod Pathol. 2007;20(9):914\u0026ndash;20.\u003c/li\u003e\n\u003cli\u003eGoenaga-V\u0026aacute;zquez Y, Col\u0026oacute;n G, Barrios N, Correa M. Renal medullary carcinoma: a nearly fatal malignancy specifically affecting patients with a so-called benign condition. CEN Case Rep. 2018;7(1):121\u0026ndash;6.\u003c/li\u003e\n\u003cli\u003eBlas L, Roberti J, Petroni J, Reniero L, Cicora F. Renal Medullary Carcinoma: a Report of the Current Literature. Curr Urol Rep. 2019;20(1):4.\u003c/li\u003e\n\u003cli\u003eWilliams TN, Mwangi TW, Wambua S, Alexander ND, Kortok M, Snow RW, et al. Sickle cell trait and the risk of Plasmodium falciparum malaria and other childhood diseases. J Infect Dis. 2005;192(1):178\u0026ndash;86.\u003c/li\u003e\n\u003cli\u003eKatale RN, Gemechu DB. Spatio-temporal analysis of malaria incidence and its risk factors in North Namibia. Malar J. 2023;22(1):149.\u003c/li\u003e\n\u003cli\u003eRunkel B, Kl\u0026uuml;ppelholz B, Rummer A, Sieben W, Lampert U, Bollig C, et al. Screening for sickle cell disease in newborns: a systematic review. Syst Reviews. 2020;9(1):250.\u003c/li\u003e\n\u003cli\u003eHenthorn JS, Almeida AM, Davies SC. Neonatal screening for sickle cell disorders. Br J Haematol. 2004;124(3):259\u0026ndash;63.\u003c/li\u003e\n\u003cli\u003eShook LM, Haygood D, Quinn CT. Clinical Utility of the Addition of Molecular Genetic Testing to Newborn Screening for Sickle Cell Anemia. Front Med. 2021;8.\u003c/li\u003e\n\u003cli\u003eAssociation of Public Health., Laboratories Centers for Disease, Control Prevention. Hemoglobinopathies: current practices for screening, confirmation and follow-up. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://stacks.cdc.gov/view/cdc/42387\u003c/span\u003e\u003c/span\u003e. 2015. Accessed 23 MARCH 2022.\u003c/li\u003e\n\u003cli\u003eKanter J. Point-of‐Care Testing in Sickle Cell Disease Sickle Cell Disease - Pain and Common. Chronic Complications Intechopen Book series; 2016.\u003c/li\u003e\n\u003cli\u003eKanter J, Telen MJ, Hoppe C, Roberts CL, Kim JS, Yang X. Validation of a novel point of care testing device for sickle cell disease. BMC Med. 2015;13(1):225.\u003c/li\u003e\n\u003cli\u003eYang X, Kanter J, Piety NZ, Benton M, Vignes SM, Shevkoplyas SS. A simple, rapid, low-cost test for the diagnosis of sickle cell disease using a paper-based hemoglobin solubility assay. Blood. 2012;120(21):245.\u003c/li\u003e\n\u003cli\u003eSteele C, Sinski A, Asibey J, Hardy-Dessources M-D, Elana G, Brennan C, et al. Point-of-care screening for sickle cell disease in low-resource settings: A multi-center evaluation of HemoTypeSC, a novel rapid test. Am J Hematol. 2019;94(1):39\u0026ndash;45.\u003c/li\u003e\n\u003cli\u003eQuinn CT, Paniagua MC, DiNello RK, Panchal A, Geisberg M. A rapid, inexpensive and disposable point-of-care blood test for sickle cell disease using novel, highly specific monoclonal antibodies. Br J Haematol. 2016;175(4):724\u0026ndash;32.\u003c/li\u003e\n\u003cli\u003eNnodu O, Isa H, Nwegbu M, Ohiaeri C, Adegoke S, Chianumba R et al. HemoTypeSC, a low-cost point-of-care testing device for sickle cell disease: Promises and challenges. Blood Cells, Molecules, and Diseases. 2019;78:22\u0026thinsp;\u0026ndash;\u0026thinsp;8.\u003c/li\u003e\n\u003cli\u003eKasai ET, Boemer F, Marini Djang\u0026rsquo;eing\u0026rsquo;a R, Ntokumunda JK, Agasa SB, Dauly NN, et al. Systematic screening of neonatal sickle cell disease with HemoTypeSC TM Kit-test: case study and literature review. Open J Blood Dis. 2020;10(01):12.\u003c/li\u003e\n\u003cli\u003eNankanja R, Kiyaga C, Geisberg M, Serrao E, Balyegyusa S. Implementation of a sickle cell disease screening initiative in Uganda with HemoTypeSCTM. American Society of Hematology Washington, DC; 2018.\u003c/li\u003e\n\u003cli\u003eSteele C, Sinski A, Asibey J, Hardy-Dessources MD, Elana G, Brennan C, et al. Point‐of‐care screening for sickle cell disease in low‐resource settings: A multi‐center evaluation of HemoTypeSC, a novel rapid test. Am J Hematol. 2019;94(1):39\u0026ndash;45.\u003c/li\u003e\n\u003cli\u003eMukherjee MB, Colah RB, Mehta PR, Shinde N, Jain D, Desai S, et al. Multicenter evaluation of HemoTypeSC as a point-of-care sickle cell disease rapid diagnostic test for newborns and adults across India. Am J Clin Pathol. 2020;153(1):82\u0026ndash;7.\u003c/li\u003e\n\u003cli\u003eOkeke CO, Chianumba RI, Isa H, Asala S, Nnodu OE. Using dried blood spot on HemoTypeSC\u0026trade;, a new frontier for newborn screening for sickle cell disease in Nigeria. Front Genet. 2022;13:1013858.\u003c/li\u003e\n\u003cli\u003eBukini D, Nkya S, McCurdy S, Mbekenga C, Manji K, Parker M et al. Perspectives on Building Sustainable Newborn Screening Programs for Sickle Cell Disease: Experience from Tanzania. Int J Neonatal Screen. 2021;7(1).\u003c/li\u003e\n\u003cli\u003eOlatunya OS, Albuquerque DM, Fagbamigbe AF, Faboya OA, Ajibola AE, Babalola OA, et al. Diagnostic Accuracy of HemotypeSC as a Point-of-Care Testing Device for Sickle Cell Disease: Findings from a Southwestern State in Nigeria and Implications for Patient Care in Resource-Poor Settings of sub-Saharan Africa. Glob Pediatr Health. 2021;8:2333794x211016789.\u003c/li\u003e\n\u003cli\u003eAdegoke SA, Oladimeji OI, Akinlosotu MA, Akinwumi AI, Matthew KA. HemoTypeSC point-of-care testing shows high sensitivity with alkaline cellulose acetate hemoglobin electrophoresis for screening hemoglobin SS and SC genotypes. Hematology, Transfusion and Cell Therapy.\u003c/li\u003e\n\u003cli\u003eOlaniyan HS, Briscoe C, Santos B, Pascoal R, Armando A, McGann PT. Comparison of Sickle SCAN and Hemotype SC As Point-of-Care Newborn Screening Diagnostics for Sickle Cell Disease in Luanda, Angola. Blood. 2021;138:913.\u003c/li\u003e\n\u003cli\u003eSegbena AY, Guindo A, Buono R, Kueviakoe I, Diallo DA, Guernec G, et al. Diagnostic accuracy in field conditions of the sickle SCAN\u0026reg; rapid test for sickle cell disease among children and adults in two West African settings: the DREPATEST study. BMC Hematol. 2018;18(1):1\u0026ndash;10.\u003c/li\u003e\n\u003cli\u003eRegional Committee for A. Sickle-Cell Disease: a strategy for the WHO African Region. 2011 2011-05-26. Contract No.: AFR/RC60/8.\u003c/li\u003e\n\u003cli\u003eAgency NS. Namibia Inter-censal Demographic Survey 2016 Report. https://cms.my.na \u0026rsaquo; documents \u0026rsaquo; NIDS_2016. Accessed 28 April 2023. 2016.\u003c/li\u003e\n\u003cli\u003eChunda-Liyoka C, Kumar AA, Sambo P, Lubinda F, Nchimba L, Humpton T, et al. Application of a public health strategy to large-scale point-of-care screening for sickle cell disease in rural sub-Saharan Africa. Blood Adv. 2018;2(Supplement1):1\u0026ndash;3.\u003c/li\u003e\n\u003cli\u003eKasai E, Boemer F, Marini RD, Kadima J, Agasa S, Dauly N, et al. Systematic Screening of Neonatal Sickle Cell Disease with HemoTypeSC\u0026thinsp;\u0026lt;\u0026thinsp;sup\u0026thinsp;\u0026gt;\u0026thinsp;TM\u0026thinsp;Kit-Test: Case Study and Literature Review. Open J Blood Dis. 2020;10:12\u0026ndash;21.\u003c/li\u003e\n\u003cli\u003eDexter D, McGann PT. Saving lives through early diagnosis: the promise and role of point of care testing for sickle cell disease. Br J Haematol. 2022;196(1):63\u0026ndash;9.\u003c/li\u003e\n\u003cli\u003eMunyanganizi R, Cotton F, Vertongen F, Gulbis B. Red blood cell disorders in Rwandese neonates: screening for sickle cell disease and glucose-6-phosphate dehydrogenase deficiency. J Med Screen. 2006;13(3):129\u0026ndash;31.\u003c/li\u003e\n\u003cli\u003eOdunvbun ME, Okolo AA, Rahimy CM. Newborn screening for sickle cell disease in a Nigerian hospital. Public Health. 2008;122(10):1111\u0026ndash;6.\u003c/li\u003e\n\u003cli\u003eEastburg L, Peckham A, Kawira E, Chirangi B, Adler D, Akungo BD, et al. Extremely high birth prevalence of sickle cell disease in rural Tanzania. Pediatr Blood Cancer. 2020;67(11):e28620.\u003c/li\u003e\n\u003cli\u003eK-State PL. PRINCIPLES OF BIOLOGY2000.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-pediatrics","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bped","sideBox":"Learn more about [BMC Pediatrics](http://bmcpediatr.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/bped/default.aspx","title":"BMC Pediatrics","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Hemotype SC™, newborn screening, sickle cell disease, malaria prone region","lastPublishedDoi":"10.21203/rs.3.rs-3753291/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-3753291/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground\u003c/strong\u003e: Sickle cell disease (SCD), a non-communicable disease has its highest burden in Sub Saharan Africa. The majority of children (50-90%), with SCD die before their 5\u003csup\u003eth\u003c/sup\u003e birthday with approximately 150,000–300,000 annual SCD child deaths in Africa. In developed countries, newborn screening (NBS) has been shown to improve survival of children with sickle cell disease with under 5 childhood mortality reduced 10 fold due to interventions done before development of complications. Point of care tests have been developed for resource limited settings to expand newborn screening. The aim of the study was to determine the birth prevalence of sickle cell disease using the point of care test HemoTypeSC in Namibia.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e: A cross sectional descriptive study was carried out at Rundu Intermediate hospital in Kavango East Region. Two hundred and two (202) well newborns within 72 hours of birth were recruited in the study from 22 of February to the 28\u003csup\u003eth\u003c/sup\u003e of March 2023. Descriptive statistics was used to compute the hemoglobin types of the study participants.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults\u003c/strong\u003e: The majority of the participants (n=105) (52%) were females and (n= 97) ,(48%) males. The median age of the participants was 23 hours interquartile range (IQR), (11-33 hours) with the age range of 2-98 hours. One hundred and eight three (183) ( 90.6%) had normal haemoglobin HbAA; 19 (9.4%) sickle cell trait (HbAS) and no participant was found to have sickle cell disease (HbSS).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusions\u003c/strong\u003e: The study is the first to carry out birth prevalence for SCD and sickle cell trait as well as the first application of HemotypeSC as screening method in Namibia. There was a high prevalence of sickle cell trait but no SCD. This is a baseline study that can inform policy on the possible adoption of sickle cell disease newborn screening in Namibia.\u003c/p\u003e","manuscriptTitle":"Determination of birth prevalence of sickle cell disease using point of care test HemoTypeSC TM at Rundu hospital, Namibia","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2023-12-19 19:18:03","doi":"10.21203/rs.3.rs-3753291/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2024-03-08T11:30:25+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-02-17T18:54:12+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"3755b262-967b-4bb8-8708-494668057a43","date":"2024-01-02T15:11:48+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2023-12-28T02:14:43+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"86427556-d787-40a1-b5ca-1c53743def29","date":"2023-12-27T06:46:43+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2023-12-27T04:36:06+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2023-12-27T04:30:22+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2023-12-14T13:08:34+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2023-12-14T13:06:29+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Pediatrics","date":"2023-12-14T11:39:39+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-pediatrics","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bped","sideBox":"Learn more about [BMC Pediatrics](http://bmcpediatr.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/bped/default.aspx","title":"BMC Pediatrics","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"c20bb6f4-8704-4e7c-aa33-689087a60043","owner":[],"postedDate":"December 19th, 2023","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2024-05-14T21:31:26+00:00","versionOfRecord":{"articleIdentity":"rs-3753291","link":"https://doi.org/10.1186/s12887-024-04805-z","journal":{"identity":"bmc-pediatrics","isVorOnly":false,"title":"BMC Pediatrics"},"publishedOn":"2024-05-10 21:18:02","publishedOnDateReadable":"May 10th, 2024"},"versionCreatedAt":"2023-12-19 19:18:03","video":"","vorDoi":"10.1186/s12887-024-04805-z","vorDoiUrl":"https://doi.org/10.1186/s12887-024-04805-z","workflowStages":[]},"version":"v1","identity":"rs-3753291","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-3753291","identity":"rs-3753291","version":["v1"]},"buildId":"7rjqhiLT3MXkJMwkYKINL","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}