Point-of-care rapid diagnostic tests (POC-RDTs) are widely used to screen and diagnose hepatitis B virus (HBV) infection and are often the only available diagnostic tools in resource-limited settings. The aim of this study was to evaluate the validity of three hepatitis B surface antigen (HBsAg) POC-RDTs (Healgen®, Advanced Quality™ and Determine™) in an area with high prevalence of HBV in eastern Ethiopia. Results were compared with a commercial enzyme linked immunosorbent assay (ELISA) as gold standard. Quantification of HBsAg was performed in false negative samples.

A total of 511 subjects were screened, of whom 81 (15.9 %) were HBsAg-positive with the gold standard. All three POC-RDTs were positive in 65 of the 81 positive samples, yielding a sensitivity (95 % confidence interval) of 80.2 % (70.3−87.5) and a specificity of 99.8 % (98.7−100 for Healgen® and Determine™; 98.6−100 for Advanced Quality™). False negatives were observed in 16 patients associated with low levels of HBsAg (median 1.5 IU/mL). All three POC-RDTs had reasonably high sensitivity and excellent specificity, but false negative results were observed in patients with low titres of HBsAg. Thus, these POC-RDTs might be useful to identify patients in need of HBV treatment, but cannot be recommended as blood donor screening tests.

床旁快速诊断测试 (POC-RDT) 广泛用于筛查和诊断乙型肝炎病毒 (HBV) 感染，并且通常是资源有限环境中唯一可用的诊断工具。本研究的目的是评估三种乙型肝炎表面抗原 (HBsAg) POC-RDT（Healgen®、Advanced Quality™ 和 Confirm™）在埃塞俄比亚东部 HBV 高流行地区的有效性。结果与作为金标准的商业酶联免疫吸附测定 (ELISA) 进行了比较。HBsAg 的定量是在假阴性样本中进行的。

共筛选了 511 名受试者，其中 81 名 (15.9 %) 为金标准的 HBsAg 阳性。所有三种 POC-RDT 在 81 个阳性样本中的 65 个中均为阳性，产生 80.2 % (70.3-87.5) 的敏感性（95 % 置信区间）和 99.8 % 的特异性（Healgen® 和确定™ 为 98.7-100；98.6 -100 为 Advanced Quality™）。在 16 名与低水平 HBsAg（中值 1.5 IU/mL）相关的患者中观察到假阴性。所有三种 POC-RDT 都具有相当高的灵敏度和出色的特异性，但在 HBsAg 滴度低的患者中观察到假阴性结果。因此，这些 POC-RDT 可能有助于识别需要 HBV 治疗的患者，但不能推荐作为献血者筛查测试。