Department of Clinical Laboratory Medicine, The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Department of Infectious Disease, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
J Clin Lab Anal. 2020 Jul;34(7):e23281. doi: 10.1002/jcla.23281. Epub 2020 Mar 10.
Detection of hepatitis B virus (HBV) is vital for the diagnosis of hepatitis B infection. A novel test loop-mediated isothermal amplification (LAMP) has been successfully applied to detect various pathogens. However, the accuracy of LAMP in diagnosing HBV remains unclear. Therefore, in the present study, the accuracy of LAMP for HBV detection was evaluated systematically.
Embase, Cochrane Library, and PubMed databases were searched for studies using LAMP to detect HBV. Then, two researchers extracted data and assessed the quality of literature using the QUADAS-2 tool independently. I statistic and chi-square test were analyzed to investigate the heterogeneity, and Deek's funnel plot assessed the publication bias. The pooled sensitivity (SEN), specificity (SPE), positive LR (PLR), negative LR (NLR), diagnostic odds ratio (DOR), and 95% confidence intervals were displayed in forest plots. We calculated the area under the curve (AUC) to assess the overall efficiency of LAMP for HBV detection.
A total of nine studies with 1298 samples were finally included in this evaluation. The pooled sensitivity and specificity of HBV detection were 0.91 (95% CI: 0.89 ~ 0.92) and 0.97 (95% CI: 0.94 ~ 0.99), respectively. The PLR, NLR, and DOR were 16.93 (95% CI: 6.15 ~ 46.55), 0.08 (95% CI: 0.05 ~ 0.14), and 397.57 (95% CI: 145.41 ~ 1087.07). Besides, the AUC was 0.9872, and Deek's plot suggested that there existed publication bias in the studies.
Compared with PCR, LAMP is a simple, rapid, and effective assay to diagnose HBV. However, additional evidence is essential to confirm that LAMP can replace other methods in diagnosing HBV infection.
乙型肝炎病毒 (HBV) 的检测对于乙型肝炎感染的诊断至关重要。一种新的检测方法——环介导等温扩增 (LAMP) 已成功应用于检测各种病原体。然而，LAMP 诊断 HBV 的准确性尚不清楚。因此，本研究系统评估了 LAMP 检测 HBV 的准确性。
检索 Embase、Cochrane 图书馆和 PubMed 数据库，使用 LAMP 检测 HBV 的研究。然后，两名研究人员独立提取数据并使用 QUADAS-2 工具评估文献质量。采用 I ² 和卡方检验分析异质性，Deek 漏斗图评估发表偏倚。汇总灵敏度 (SEN)、特异性 (SPE)、阳性似然比 (PLR)、阴性似然比 (NLR)、诊断比值比 (DOR) 和 95%置信区间以森林图展示。计算曲线下面积 (AUC) 以评估 LAMP 检测 HBV 的总体效率。
最终纳入 9 项研究共 1298 例样本。HBV 检测的汇总灵敏度和特异性分别为 0.91（95%CI：0.890.92）和 0.97（95%CI：0.940.99）。PLR、NLR 和 DOR 分别为 16.93（95%CI：6.1546.55）、0.08（95%CI：0.050.14）和 397.57（95%CI：145.41~1087.07）。此外，AUC 为 0.9872，Deek 图表明研究中存在发表偏倚。
与 PCR 相比，LAMP 是一种简单、快速、有效的 HBV 诊断方法。然而，需要更多的证据来证实 LAMP 可以替代其他方法来诊断 HBV 感染。
