Hepatitis B virus (HBV): serological markers of infection and immunity in a cohort of South African children

Children age 6-60 months were recruited as part of the Co-infection in South-African Children (COSAC) study, in Kimberley, South Africa. HIV-negative participants (n=174) were recruited through the Kimberley Respiratory Cohort (KReC). These children were admitted to hospital with a clinical diagnosis of respiratory tract infection between July 2014 and August 2016. HIV-positive children (n=136) were recruited primarily from HIV outpatient clinics, (recruited between September 2009 and July 2016). Children had research blood samples taken at the same time as routine clinical blood tests. We tested all samples for markers of hepatitis B virus (HBV) infection and immunity. HBsAg testing was carried out in Kimberley Hospital, South Africa using the Magnetic parcel chemiluminometric immunoassay (MPCI; Advia Centaur platform). Confirmatory HBsAg testing, together with anti-HBs and anti-HBc testing, was carried out by the microbiology department at Oxford University Hospitals (OUH) NHS Foundation Trust, Oxford, UK (Architect i2000). Ethics approval for this study was obtained from the Ethics Committee of the Faculty of Health Science, University of the Free State, Bloemfontein, South Africa (HIV Study Ref: ETOVS Nr 08/09 and COSAC Study Ref: ECUFS NR 80/2014). Written consent for enrollment into the study was obtained from the child’s parent or guardian.

本研究招募6至60个月龄的儿童作为南非儿童合并感染研究（Co-infection in South-African Children, 简称COSAC）的研究对象，研究开展于南非金伯利市。HIV阴性参与者（n=174）通过金伯利呼吸队列（Kimberley Respiratory Cohort, 简称KReC）招募，这些儿童于2014年7月至2016年8月期间因临床诊断为呼吸道感染住院治疗。HIV阳性儿童（n=136）主要从HIV门诊诊所招募，招募时段为2009年9月至2016年7月。所有儿童在接受常规临床血液检测的同时，采集了科研用血液样本。本研究对所有样本开展了乙型肝炎病毒（hepatitis B virus, 简称HBV）感染与免疫相关标志物的检测。乙型肝炎表面抗原（HBsAg）检测在南非金伯利医院完成，采用磁微粒化学发光免疫分析法（Magnetic parcel chemiluminometric immunoassay, 简称MPCI；Advia Centaur检测平台）。确认性HBsAg检测，以及乙型肝炎表面抗体（anti-HBs）、乙型肝炎核心抗体（anti-HBc）检测，由英国牛津大学医院国民保健信托基金会（Oxford University Hospitals NHS Foundation Trust, 简称OUH）的微生物学部门完成，检测平台为Architect i2000。本研究已获得南非自由州大学健康科学学院伦理委员会的伦理批准（HIV研究编号：ETOVS Nr 08/09；COSAC研究编号：ECUFS NR 80/2014）。所有研究对象的父母或法定监护人均已签署书面知情同意书，同意儿童纳入本研究。