Woldemedihn Gezahegn Mekonnen, Rueegg Corina Silvia, Desalegn Hailemichael, Aberra Hanna, Berhe Nega, Johannessen Asgeir
Department of Statistics, Hawassa University, PO Box 05, Hawassa, Ethiopia.
Oslo Centre for Biostatistics and Epidemiology, Oslo University Hospital, PO Box 4950, Nydalen, 0424, Oslo, Norway.
J Virol Methods. 2021 Mar;289:114057. doi: 10.1016/j.jviromet.2020.114057. Epub 2020 Dec 29.
The recent launch of the first point-of-care Xpert® hepatitis B virus (HBV) viral load kit from Cepheid could help to scale up treatment for chronic hepatitis B (CHB) in resource-limited settings. This study aimed to assess the performance of the Xpert kit under field conditions in Ethiopia. One-hundred-and-thirty CHB patients with viral loads ranging from <1 log to>7 log IU/mL were randomly sampled. The viral load was assessed with both the Xpert and the gold standard Abbott RealTime HBV Viral Load assay in each patient. There was a high correlation between the viral loads assessed by Xpert and Abbott (r = 0.948, p < 0.001). The Bland-Altman plot showed a small bias between the two assays, with an on average 0.23 log IU/mL higher viral load result of the Xpert kit; 4 samples differed by>1 log IU/mL. Using the treatment threshold of 2000 IU/mL in both tests, Xpert had a sensitivity of 94 %, specificity of 71 %, positive predictive value of 70 %, and negative predictive value of 95 %. In conclusion, the Xpert kit demonstrated good validity for the measurement of HBV viral load in a real-life setting.
赛沛公司近期推出的首款即时检测(POC)Xpert® 乙型肝炎病毒(HBV)病毒载量检测试剂盒,有助于在资源有限的环境中扩大慢性乙型肝炎(CHB)的治疗规模。本研究旨在评估Xpert试剂盒在埃塞俄比亚现场条件下的性能。随机抽取了130例病毒载量范围从<1 log到>7 log IU/mL的CHB患者。对每位患者同时使用Xpert和金标准雅培实时HBV病毒载量检测法评估病毒载量。Xpert和雅培检测的病毒载量之间存在高度相关性(r = 0.948,p < 0.001)。Bland-Altman图显示两种检测方法之间存在较小偏差,Xpert试剂盒的病毒载量结果平均高0.23 log IU/mL;4个样本的差异>1 log IU/mL。在两种检测中均使用2000 IU/mL的治疗阈值,Xpert的灵敏度为94%,特异性为71%,阳性预测值为70%,阴性预测值为95%。总之,Xpert试剂盒在实际应用中对HBV病毒载量的测量显示出良好的有效性。