Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.
Centre for Infectious Disease Research in Zambia, Lusaka, Zambia; School of Medicine, University of Zambia, Lusaka, Zambia.
J Clin Virol. 2018 Jan;98:5-7. doi: 10.1016/j.jcv.2017.11.005. Epub 2017 Nov 16.
We evaluated the field performance of a rapid point-of-care (POC) test for hepatitis B surface antigen (HBsAg) that could support decentralization and scale-up of hepatitis B virus (HBV) diagnosis in Africa.
To determine the field performance of the Determine HBsAg POC test for diagnosis of HBV co-infection among HIV patients in Zambia.
Between 2013-2014, we screened HIV-infected adults for HBsAg at two urban clinics in Zambia. A subset were tested with the POC Determine HBsAg (Alere, USA) by finger prick in the clinic and HBsAg serology (Access2Analyzer, Beckman Coulter) at a reference laboratory. If either test was reactive, we determined HBV viral load (VL) and genotype. We described patient demographic and clinical characteristics (including liver fibrosis) and assessed the sensitivity, specificity, positive and negative predictive values (PPV and NPV) of the Determine test. In secondary analyses, we assessed sensitivity among patients with replicating HBV (i.e., VL>20 IU/ml) and with high HBV VL (i.e.,>20,000IU/ml).
Among 412 participants with both HBsAg tests, median age was 34 years, 51% were women, and median CD4 was 208 cells/mm. By serology, 66 (16%) were HBsAg-positive. Overall Determine had 87.9% sensitivity, 99.7% specificity, 98.3% PPV, and 97.7% NPV. Six of 8 patients with false negative results had undetectable HBV VL and no evidence of significant liver fibrosis. Test sensitivity was 95.9% among the 51 with replicating HBV and 100% among the 28 with high HBV VL.
Determine HBsAg is a cheaper alternative HBV testing option compared to the gold standard ELISA and has high specificity and good sensitivity in the field among HIV-infected individuals.
我们评估了一种用于乙型肝炎表面抗原（HBsAg）的即时检验（POC），它可以支持乙型肝炎病毒（HBV）诊断在非洲的分散和扩大。
确定 Determine HBsAg POC 试验在赞比亚 HIV 感染者中诊断乙型肝炎病毒合并感染的现场性能。
2013-2014 年，我们在赞比亚的两个城市诊所筛选了感染 HIV 的成年人的 HBsAg。一部分人通过诊所的指尖采血和参考实验室的 HBsAg 血清学（Access2Analyzer，Beckman Coulter）用 POC Determine HBsAg（Alere，美国）进行检测。如果任何一种检测都呈阳性，我们就确定 HBV 病毒载量（VL）和基因型。我们描述了患者的人口统计学和临床特征（包括肝纤维化），并评估了 Determine 试验的敏感性、特异性、阳性和阴性预测值（PPV 和 NPV）。在二次分析中，我们评估了在复制性 HBV （即 VL>20IU/ml）和高 HBV VL （即>20,000IU/ml）的患者中的敏感性。
在 412 名同时进行 HBsAg 检测的参与者中，中位年龄为 34 岁，51%为女性，中位 CD4 为 208 个细胞/mm。根据血清学，66 人（16%）HBsAg 阳性。总体而言，Determine 的敏感性为 87.9%，特异性为 99.7%，PPV 为 98.3%，NPV 为 97.7%。8 名假阴性结果中有 6 名患者的 HBV VL 无法检测，且无明显肝纤维化证据。在 51 名复制性 HBV 患者中，检测的敏感性为 95.9%，在 28 名高 HBV VL 患者中为 100%。
与金标准 ELISA 相比，Determine HBsAg 是一种更便宜的乙型肝炎病毒检测选择，在 HIV 感染者中具有较高的特异性和良好的现场敏感性。
