Department of Biomedical Laboratory Science, College of Medicine, University of Ibadan, Ibadan, Nigeria.
Department of Haematology, College of Medicine, University of Ibadan, University College Hospital, Ibadan, Nigeria.
West Afr J Med. 2021 Jan;38(1):19-23.
The Hepatitis B surface Antigen (HBsAg) is the most utilized indicator marker of hepatitis B infection. This study assesses the accuracy of the two most common screening assays used to detect HBsAg among blood donors.
A total of 350 eligible blood donors were screened for HBsAg using both Bio-Check HBsAg Rapid screening kit (BioCheck Inc, South San Francisco, USA) and a fourth-generation Enzyme-Linked Immunoassays (ELISA) kit, MonolisaTM HBs Ag Ultra (Bio-Rad Laboratories, Marnes-la-Coquette-France). Questionnaires were used to inquire about risk factors for HBV infection among blood donors. The calculation of sensitivity, specificity, negative predictive and positive predictive values were carried out by comparing the performance of the rapid kit with ELISA test as the reference standard.
The prevalence of HBV infection using Rapid Diagnostic Test (RDT) was 5.7% but was 14.6% by ELISA. Using ELISA as a reference, the sensitivity and specificity of RDT were 31.4% and 98.7% respectively. The positive predictive value and negative predictive value for RDT were 80.0% and 89.4% respectively. Overall non-compliance with transfusion-transmitted infection (TTI) risk-related deferral criteria was 38%.
The low sensitivity of RDT kits precludes its continuous use in high HBV endemic regions where many donors fail to disclose full and truthful information about their risk for TTI. It is suggested that blood banks should complement the use of RDT with a more sensitive assay such as ELISA.
乙肝表面抗原（HBsAg）是乙型肝炎感染最常用的指标标志物。本研究评估了两种最常用于检测献血者 HBsAg 的常用筛选检测方法的准确性。
使用 Bio-Check HBsAg 快速筛选试剂盒（BioCheck Inc，美国旧金山南部）和第四代酶联免疫吸附试验（ELISA）试剂盒 MonolisaTM HBsAg Ultra（Bio-Rad Laboratories，法国马恩河畔拉科克）对 350 名符合条件的献血者进行 HBsAg 筛查。使用问卷询问献血者乙型肝炎病毒感染的危险因素。通过将快速试剂盒的性能与 ELISA 测试作为参考标准进行比较，计算敏感性、特异性、阴性预测值和阳性预测值。
使用快速诊断测试（RDT）的乙型肝炎病毒感染率为 5.7%，而 ELISA 的感染率为 14.6%。使用 ELISA 作为参考，RDT 的敏感性和特异性分别为 31.4%和 98.7%。RDT 的阳性预测值和阴性预测值分别为 80.0%和 89.4%。总体而言，不符合输血传播感染（TTI）相关延期标准的比例为 38%。
RDT 试剂盒的敏感性低，不适合在乙型肝炎高发地区连续使用，因为许多献血者未能充分真实地披露其 TTI 风险信息。建议血库应在使用 RDT 的基础上补充更敏感的检测方法，如 ELISA。
