Performance Evaluation of a Fully Automated Molecular Diagnostic System for Multiplex Detection of SARS-CoV-2, Influenza A/B Viruses, and Respiratory Syncytial Virus
<b data-eusoft-scrollable-element="1">Background/Objectives</b>: 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 laborator...
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MDPI AG
2025-07-01
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| Online Access: | https://www.mdpi.com/2075-4418/15/14/1791 |
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| author | James G. Komu Dulamjav Jamsransuren Sachiko Matsuda Haruko Ogawa Yohei Takeda |
| author_facet | James G. Komu Dulamjav Jamsransuren Sachiko Matsuda Haruko Ogawa Yohei Takeda |
| author_sort | James G. Komu |
| collection | DOAJ |
| description | <b data-eusoft-scrollable-element="1">Background/Objectives</b>: 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). <b data-eusoft-scrollable-element="1">Methods</b>: 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. <b data-eusoft-scrollable-element="1">Results</b>: 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<sup data-eusoft-scrollable-element="1">0</sup>, ≤10<sup data-eusoft-scrollable-element="1">−2</sup>, 10<sup data-eusoft-scrollable-element="1">0</sup>, and 10<sup data-eusoft-scrollable-element="1">2</sup> TCID<sub data-eusoft-scrollable-element="1">50</sub>/mL, respectively, compared to ≤10<sup data-eusoft-scrollable-element="1">−1</sup>, ≤10<sup data-eusoft-scrollable-element="1">0</sup>, ≤10<sup data-eusoft-scrollable-element="1">0</sup>, and ≤10<sup data-eusoft-scrollable-element="1">4</sup> TCID<sub data-eusoft-scrollable-element="1">50</sub>/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<sup data-eusoft-scrollable-element="1">2</sup> values of 0.90, 0.85, 0.92, and 0.95 for SARS-CoV-2, IAV, IBV, and RSV, respectively. <b data-eusoft-scrollable-element="1">Conclusions</b>: geneLEAD/VIASURE is a reliable diagnostic tool for detecting SARS-CoV-2, IAV/IBV, and RSV in single- and multiple-infection scenarios. |
| format | Article |
| id | doaj-art-f4f6239ad2d94e6cb4f17424eef4ddb8 |
| institution | Matheson Library |
| issn | 2075-4418 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | MDPI AG |
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| series | Diagnostics |
| spelling | doaj-art-f4f6239ad2d94e6cb4f17424eef4ddb82025-07-25T13:19:54ZengMDPI AGDiagnostics2075-44182025-07-011514179110.3390/diagnostics15141791Performance Evaluation of a Fully Automated Molecular Diagnostic System for Multiplex Detection of SARS-CoV-2, Influenza A/B Viruses, and Respiratory Syncytial VirusJames G. Komu0Dulamjav Jamsransuren1Sachiko Matsuda2Haruko Ogawa3Yohei Takeda4Graduate School of Animal and Veterinary Sciences and Agriculture, Obihiro University of Agriculture and Veterinary Medicine, 2-11 Inada, Obihiro 080-8555, Hokkaido, JapanResearch Center for Global Agromedicine, Obihiro University of Agriculture and Veterinary Medicine, 2-11 Inada, Obihiro 080-8555, Hokkaido, JapanResearch Center for Global Agromedicine, Obihiro University of Agriculture and Veterinary Medicine, 2-11 Inada, Obihiro 080-8555, Hokkaido, JapanDepartment of Veterinary Medicine, Obihiro University of Agriculture and Veterinary Medicine, 2-11 Inada, Obihiro 080-8555, Hokkaido, JapanResearch Center for Global Agromedicine, Obihiro University of Agriculture and Veterinary Medicine, 2-11 Inada, Obihiro 080-8555, Hokkaido, Japan<b data-eusoft-scrollable-element="1">Background/Objectives</b>: 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). <b data-eusoft-scrollable-element="1">Methods</b>: 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. <b data-eusoft-scrollable-element="1">Results</b>: 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<sup data-eusoft-scrollable-element="1">0</sup>, ≤10<sup data-eusoft-scrollable-element="1">−2</sup>, 10<sup data-eusoft-scrollable-element="1">0</sup>, and 10<sup data-eusoft-scrollable-element="1">2</sup> TCID<sub data-eusoft-scrollable-element="1">50</sub>/mL, respectively, compared to ≤10<sup data-eusoft-scrollable-element="1">−1</sup>, ≤10<sup data-eusoft-scrollable-element="1">0</sup>, ≤10<sup data-eusoft-scrollable-element="1">0</sup>, and ≤10<sup data-eusoft-scrollable-element="1">4</sup> TCID<sub data-eusoft-scrollable-element="1">50</sub>/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<sup data-eusoft-scrollable-element="1">2</sup> values of 0.90, 0.85, 0.92, and 0.95 for SARS-CoV-2, IAV, IBV, and RSV, respectively. <b data-eusoft-scrollable-element="1">Conclusions</b>: geneLEAD/VIASURE is a reliable diagnostic tool for detecting SARS-CoV-2, IAV/IBV, and RSV in single- and multiple-infection scenarios.https://www.mdpi.com/2075-4418/15/14/1791multiplex RT-qPCRautomationsample-to-resultSARS-CoV-2influenza virusesRSV |
| spellingShingle | James G. Komu Dulamjav Jamsransuren Sachiko Matsuda Haruko Ogawa Yohei Takeda Performance Evaluation of a Fully Automated Molecular Diagnostic System for Multiplex Detection of SARS-CoV-2, Influenza A/B Viruses, and Respiratory Syncytial Virus Diagnostics multiplex RT-qPCR automation sample-to-result SARS-CoV-2 influenza viruses RSV |
| title | Performance Evaluation of a Fully Automated Molecular Diagnostic System for Multiplex Detection of SARS-CoV-2, Influenza A/B Viruses, and Respiratory Syncytial Virus |
| title_full | Performance Evaluation of a Fully Automated Molecular Diagnostic System for Multiplex Detection of SARS-CoV-2, Influenza A/B Viruses, and Respiratory Syncytial Virus |
| title_fullStr | Performance Evaluation of a Fully Automated Molecular Diagnostic System for Multiplex Detection of SARS-CoV-2, Influenza A/B Viruses, and Respiratory Syncytial Virus |
| title_full_unstemmed | Performance Evaluation of a Fully Automated Molecular Diagnostic System for Multiplex Detection of SARS-CoV-2, Influenza A/B Viruses, and Respiratory Syncytial Virus |
| title_short | Performance Evaluation of a Fully Automated Molecular Diagnostic System for Multiplex Detection of SARS-CoV-2, Influenza A/B Viruses, and Respiratory Syncytial Virus |
| title_sort | performance evaluation of a fully automated molecular diagnostic system for multiplex detection of sars cov 2 influenza a b viruses and respiratory syncytial virus |
| topic | multiplex RT-qPCR automation sample-to-result SARS-CoV-2 influenza viruses RSV |
| url | https://www.mdpi.com/2075-4418/15/14/1791 |
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