Department of Clinical Laboratory Medicine, the Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Department of Clinical Medicine, the Sixth Clinical School of Guangzhou Medical University, Guangzhou, China.
Bioengineered. 2023 Dec;14(1):2180221. doi: 10.1080/21655979.2023.2180221.
Rapid laboratory detection is remarkably crucial to diagnosing coronavirus disease 2019 (COVID-19) infection, due to whose outbreak causes to the world pandemic. The BinaxNOW antigen card (BinaxNOW) is a simple, effective, and cheap tool to detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The meta-analysis in this study was conducted to evaluate the diagnostic performance of BinaxNOW for SARS-CoV-2. The researchers independently retrieved the related databases (PubMed, Embase, Web of Science, Cochrane Library) before May 1st, 2021, and extracted the relevant data based on the early inclusion/exclusion criterion. Quality Assessment of Diagnostic Accuracy Study-2 was used to evaluate the quality of the enrolled studies. Stata 16.0, Meta-DiSc 1.4, and Review Manager 5.3 were used to generate analytical data for the statistical analysis. 59 sets of data were identified from the seven studies included in this meta-analysis. The combined sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, diagnostic odds ratio, and their 95% confidence intervals were 0.77 (0.76 to 0.79), 0.99 (0.99 to 0.99), 65.72 (48.23 to 89.56), 0.23 (0.19 to 0.28), and 461.10 (281.55 to 755.13), respectively. The area under curve was 0.9910 in the summary receiver operating characteristic curve. BinaxNOW is beneficial for symptomatic patients' onset within 7 days. CT value and testing site may be the heterogeneity source of BinaxNOW accuracy. Moreover, this technology has an efficient performance for diagnosing COVID-19, especially in patients with heavy viral load. BinaxNOW may become a practical tool for large-scale or at-home use for COVID-19 in the post-pandemic era.Highlights● Pooled sensitivity with 0.77 and specificity with 0.99 in the BinaxNOW assay.● CT value and testing site may be the heterogeneity source of BinaxNOW accuracy.● BinaxNOW is beneficial for symptomatic patients' onset within 7 days.● BinaxNOW may become a practical tool for large-scale or at-home use for COVID-19.
快速的实验室检测对于诊断 2019 年冠状病毒病（COVID-19）感染至关重要，因为 COVID-19 的爆发导致了全球大流行。BinaxNOW 抗原卡（BinaxNOW）是一种简单、有效且廉价的检测严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）的工具。本研究中的荟萃分析旨在评估 BinaxNOW 对 SARS-CoV-2 的诊断性能。研究人员于 2021 年 5 月 1 日前独立检索了相关数据库（PubMed、Embase、Web of Science、Cochrane Library），并根据早期纳入/排除标准提取了相关数据。采用诊断准确性研究质量评估 2 版（Quality Assessment of Diagnostic Accuracy Study-2）来评估纳入研究的质量。使用 Stata 16.0、Meta-DiSc 1.4 和 Review Manager 5.3 生成统计分析的分析数据。本荟萃分析共纳入 7 项研究，共纳入 59 组数据。联合灵敏度、特异度、阳性似然比、阴性似然比、诊断比值比及其 95%置信区间分别为 0.77（0.76 至 0.79）、0.99（0.99 至 0.99）、65.72（48.23 至 89.56）、0.23（0.19 至 0.28）和 461.10（281.55 至 755.13），汇总受试者工作特征曲线下面积为 0.9910。BinaxNOW 对症状出现 7 天内的患者有益。CT 值和检测部位可能是 BinaxNOW 准确性的异质性来源。此外，该技术对 COVID-19 的诊断具有高效性能，尤其是对病毒载量高的患者。在大流行后时代，BinaxNOW 可能成为 COVID-19 大规模或家庭使用的实用工具。
