Komu James G, Jamsransuren Dulamjav, Matsuda Sachiko, Ogawa Haruko, Takeda Yohei
Graduate School of Animal and Veterinary Sciences and Agriculture, Obihiro University of Agriculture and Veterinary Medicine, 2-11 Inada, Obihiro 080-8555, Hokkaido, Japan.
Department of Medical Laboratory Sciences, College of Health Sciences, Jomo Kenyatta University of Agriculture and Technology, Nairobi P.O. Box 62000-00200, Kenya.
Diagnostics (Basel). 2025 Jul 16;15(14):1791. doi: 10.3390/diagnostics15141791.
: Concurrent outbreaks of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A and B viruses (IAV/IBV), and respiratory syncytial virus (RSV) necessitate rapid and precise differential laboratory diagnostic methods. This study aimed to evaluate the multiplex molecular diagnostic performance of the geneLEAD VIII system (Precision System Science Co., Ltd., Matsudo, Japan), a fully automated sample-to-result precision instrument, in conjunction with the VIASURE SARS-CoV-2, Flu & RSV Real Time PCR Detection Kit (CerTest Biotec, S.L., Zaragoza, Spain). : The specific detection capabilities of SARS-CoV-2, IAV/IBV, and RSV genes were evaluated using virus-spiked saliva and nasal swab samples. Using saliva samples, the viral titer detection limits of geneLEAD/VIASURE and manual referent singleplex RT-qPCR assays were compared. The performance of geneLEAD/VIASURE in analyzing single- and multiple-infection models was scrutinized. The concordance between the geneLEAD/VIASURE and the manual assays was assessed. : The geneLEAD/VIASURE successfully detected all the virus genes in the saliva and nasal swab samples despite some differences in the Ct values. The viral titer detection limits in the saliva samples for SARS-CoV-2, IAV, IBV, and RSV using geneLEAD/VIASURE were 10, ≤10, 10, and 10 TCID/mL, respectively, compared to ≤10, ≤10, ≤10, and ≤10 TCID/mL, respectively, in the manual assays. geneLEAD/VIASURE yielded similar Ct values in the single- and multiple-infection models, with some exceptions noted in the triple-infection models when low titers of RSV were spiked with high titers of the other viruses. The concordance between geneLEAD/VIASURE and the manual assays was high, with Pearson's R values of 0.90, 0.85, 0.92, and 0.95 for SARS-CoV-2, IAV, IBV, and RSV, respectively. : geneLEAD/VIASURE is a reliable diagnostic tool for detecting SARS-CoV-2, IAV/IBV, and RSV in single- and multiple-infection scenarios.
严重急性呼吸综合征冠状病毒2（SARS-CoV-2）、甲型和乙型流感病毒（IAV/IBV）以及呼吸道合胞病毒（RSV）同时爆发，需要快速且精确的实验室鉴别诊断方法。本研究旨在评估geneLEAD VIII系统（日本松户市精密系统科学有限公司）这一全自动样本到结果的精密仪器，结合VIASURE SARS-CoV-2、流感及RSV实时荧光定量PCR检测试剂盒（西班牙萨拉戈萨市CerTest Biotec公司）的多重分子诊断性能。
使用添加病毒的唾液和鼻拭子样本评估SARS-CoV-2、IAV/IBV和RSV基因的特异性检测能力。使用唾液样本，比较geneLEAD/VIASURE和手动参考单重逆转录定量聚合酶链反应（RT-qPCR）检测方法的病毒滴度检测限。仔细检查geneLEAD/VIASURE在分析单重和多重感染模型中的性能。评估geneLEAD/VIASURE与手动检测方法之间的一致性。
尽管Ct值存在一些差异，但geneLEAD/VIASURE成功检测出唾液和鼻拭子样本中的所有病毒基因。使用geneLEAD/VIASURE检测唾液样本中SARS-CoV-2、IAV、IBV和RSV的病毒滴度检测限分别为10、≤10、10和10 TCID/mL，而手动检测方法中的检测限分别为≤10、≤10、≤10和≤10 TCID/mL。在单重和多重感染模型中，geneLEAD/VIASURE产生的Ct值相似，但在三重感染模型中，当低滴度的RSV与高滴度的其他病毒混合时，有一些例外情况。geneLEAD/VIASURE与手动检测方法之间的一致性很高，SARS-CoV-2、IAV、IBV和RSV的Pearson相关系数R值分别为0.90、0.85、0.92和0.95。
geneLEAD/VIASURE是在单重和多重感染情况下检测SARS-CoV-2、IAV/IBV和RSV的可靠诊断工具。
