Lim Ho-Jae, Park Jung-Eun, Park Min-Young, Baek Joo-Hwan, Jung Sunkyung, Sung Nackmoon, Yang Jae-Hyun, Lee Min-Woo, Lee Sun-Hwa, Yang Yong-Jin
Department of Molecular Diagnostics, Seegene Medical Foundation, Seoul 04805, Korea.
Department of Integrative Biological Sciences & BK21 FOUR Educational Research Group for Age-Associated Disorder Control Technology, Chosun University, Gwangju 61452, Korea.
Diagnostics (Basel). 2021 Jun 13;11(6):1084. doi: 10.3390/diagnostics11061084.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) triggers disease with nonspecific symptoms that overlap those of infections caused by other seasonal respiratory viruses (RVs), such as the influenza virus (Flu) or respiratory syncytial virus (RSV). A molecular assay for accurate and rapid detection of RV and SARS-CoV-2 is crucial to manage these infections. Here, we compared the analytical performance and clinical reliability of Allplex™ SARS-CoV-2/FluA/FluB/RSV (SC2FabR; Seegene Inc., Seoul, South Korea) kit with those of four commercially available RV detection kits. Upon testing five target viral strains (SARS-CoV-2, FluA, FluB, RSV A, and RSV B), the analytical performance of SC2FabR was similar to that of the other kits, with no significant difference ( ≥ 0.78) in z-scores. The efficiency of SC2FabR (E-value, 81-104%) enabled reliable SARS-CoV-2 and seasonal RV detection in 888 nasopharyngeal swab specimens processed using a fully automated nucleic acid extraction platform. Bland-Altman analyses revealed an agreement value of 95.4% (SD ± 1.96) for the kits, indicating statistically similar results for all five. In conclusion, SC2FabR is a rapid and accurate diagnostic tool for both SARS-CoV-2 and seasonal RV detection, allowing for high-throughput RV analysis with efficiency comparable to that of commercially available kits. This can be used to help manage respiratory infections in patients during and after the coronavirus disease 2019 pandemic.
严重急性呼吸综合征冠状病毒2（SARS-CoV-2）引发的疾病具有非特异性症状，与其他季节性呼吸道病毒（RVs），如流感病毒（Flu）或呼吸道合胞病毒（RSV）引起的感染症状重叠。一种用于准确快速检测RV和SARS-CoV-2的分子检测方法对于管理这些感染至关重要。在此，我们将Allplex™ SARS-CoV-2/FluA/FluB/RSV（SC2FabR；韩国首尔Seegene公司）试剂盒的分析性能和临床可靠性与四种市售RV检测试剂盒进行了比较。在检测五种目标病毒株（SARS-CoV-2、FluA、FluB、RSV A和RSV B）时，SC2FabR的分析性能与其他试剂盒相似，z值无显著差异（≥0.78）。SC2FabR的效率（E值，81-104%）使得在使用全自动核酸提取平台处理的888份鼻咽拭子标本中能够可靠地检测SARS-CoV-2和季节性RV。Bland-Altman分析显示试剂盒的一致性值为95.4%（标准差±1.96），表明所有五种试剂盒的结果在统计学上相似。总之，SC2FabR是一种用于检测SARS-CoV-2和季节性RV的快速准确的诊断工具，能够进行高通量RV分析，其效率与市售试剂盒相当。这可用于帮助管理2019冠状病毒病大流行期间及之后患者的呼吸道感染。
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