Evaluation of the cobas SARS-CoV-2 & Influenza A/B v2 assay for detecting SARS-CoV-2 and influenza A and B viruses in nasopharyngeal swab specimens
ABSTRACT Accurate and rapid diagnostic assays that simultaneously detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and influenza A/B are crucial for effective clinical management and infection control. In the present study, we evaluated the cobas SARS-CoV-2 & Influenza A/B v2...
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American Society for Microbiology
2025-08-01
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| Series: | Microbiology Spectrum |
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| Online Access: | https://journals.asm.org/doi/10.1128/spectrum.01111-25 |
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| author | Eunjung Jeong Minhee Kang Hyeonseek Park Ji-Youn Kim Sun Ae Yun Yun Young Cho Jae-Hoon Ko Tae Yeul Kim Hee Jae Huh Nam Yong Lee |
| author_facet | Eunjung Jeong Minhee Kang Hyeonseek Park Ji-Youn Kim Sun Ae Yun Yun Young Cho Jae-Hoon Ko Tae Yeul Kim Hee Jae Huh Nam Yong Lee |
| author_sort | Eunjung Jeong |
| collection | DOAJ |
| description | ABSTRACT Accurate and rapid diagnostic assays that simultaneously detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and influenza A/B are crucial for effective clinical management and infection control. In the present study, we evaluated the cobas SARS-CoV-2 & Influenza A/B v2 assay (Roche Diagnostics, Basel, Switzerland) using the Roche cobas 5800 system, comparing it to the Allplex SARS-CoV-2/FluA/FluB/RSV assay (Seegene, Seoul, Republic of Korea). A total of 871 nasopharyngeal swab specimens, including 164 SARS-CoV-2-positive, 76 influenza A-positive, 77 influenza B-positive, and 554 negative specimens, were tested using the cobas and Allplex assays in parallel. The positive percent agreement and negative percent agreement between the cobas and Allplex assays were 100% and 98.3% for SARS-CoV-2, 100% and 99.1% for influenza A, and 100% and 99.3% for influenza B, respectively. Cohen’s kappa values ranged from 0.95 to 0.96, indicating almost perfect agreement. The limits of detection for SARS-CoV-2 E and open reading frame 1ab genes, influenza A, and influenza B were 25.3, 12.4, 16.1, and 11.0 copies/mL, respectively. No cross-reactivity was observed with 29 non-target respiratory pathogens. These findings demonstrate that the cobas assay reliably detects SARS-CoV-2 and influenza A/B with high sensitivity and specificity. Notably, this assay enables high-throughput automated workflows, facilitating timely decision-making during SARS-CoV-2 and influenza cocirculation.IMPORTANCEAccurate and rapid diagnostic assays that simultaneously detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and influenza A/B are essential for effective clinical management and infection control. This study demonstrates that the cobas SARS-CoV-2 & Influenza A/B v2 assay reliably detects SARS-CoV-2 and influenza A/B with high sensitivity and specificity. Designed for use on the cobas 5800/6800/8800 systems, this assay supports high-throughput automated workflows, enabling timely decision-making during periods of high testing demand, such as the cocirculation of SARS-CoV-2 and influenza. |
| format | Article |
| id | doaj-art-9b7ca9d1493f4ee68ea9d7b90697a5b9 |
| institution | Kabale University |
| issn | 2165-0497 |
| language | English |
| publishDate | 2025-08-01 |
| publisher | American Society for Microbiology |
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| series | Microbiology Spectrum |
| spelling | doaj-art-9b7ca9d1493f4ee68ea9d7b90697a5b92025-08-20T03:38:59ZengAmerican Society for MicrobiologyMicrobiology Spectrum2165-04972025-08-0113810.1128/spectrum.01111-25Evaluation of the cobas SARS-CoV-2 & Influenza A/B v2 assay for detecting SARS-CoV-2 and influenza A and B viruses in nasopharyngeal swab specimensEunjung Jeong0Minhee Kang1Hyeonseek Park2Ji-Youn Kim3Sun Ae Yun4Yun Young Cho5Jae-Hoon Ko6Tae Yeul Kim7Hee Jae Huh8Nam Yong Lee9Biomedical Engineering Research Center, Smart Healthcare Research Institute, Samsung Medical Center, Gangnam-gu, Seoul, Republic of KoreaBiomedical Engineering Research Center, Smart Healthcare Research Institute, Samsung Medical Center, Gangnam-gu, Seoul, Republic of KoreaBiomedical Engineering Research Center, Smart Healthcare Research Institute, Samsung Medical Center, Gangnam-gu, Seoul, Republic of KoreaResearch Institute for Future Medicine, Samsung Medical Center, Gangnam-gu, Seoul, Republic of KoreaResearch Institute for Future Medicine, Samsung Medical Center, Gangnam-gu, Seoul, Republic of KoreaResearch Institute for Future Medicine, Samsung Medical Center, Gangnam-gu, Seoul, Republic of KoreaDivision of Infectious Diseases, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Gangnam-gu, Seoul, Republic of KoreaDepartment of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Gangnam-gu, Seoul, Republic of KoreaDepartment of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Gangnam-gu, Seoul, Republic of KoreaDepartment of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Gangnam-gu, Seoul, Republic of KoreaABSTRACT Accurate and rapid diagnostic assays that simultaneously detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and influenza A/B are crucial for effective clinical management and infection control. In the present study, we evaluated the cobas SARS-CoV-2 & Influenza A/B v2 assay (Roche Diagnostics, Basel, Switzerland) using the Roche cobas 5800 system, comparing it to the Allplex SARS-CoV-2/FluA/FluB/RSV assay (Seegene, Seoul, Republic of Korea). A total of 871 nasopharyngeal swab specimens, including 164 SARS-CoV-2-positive, 76 influenza A-positive, 77 influenza B-positive, and 554 negative specimens, were tested using the cobas and Allplex assays in parallel. The positive percent agreement and negative percent agreement between the cobas and Allplex assays were 100% and 98.3% for SARS-CoV-2, 100% and 99.1% for influenza A, and 100% and 99.3% for influenza B, respectively. Cohen’s kappa values ranged from 0.95 to 0.96, indicating almost perfect agreement. The limits of detection for SARS-CoV-2 E and open reading frame 1ab genes, influenza A, and influenza B were 25.3, 12.4, 16.1, and 11.0 copies/mL, respectively. No cross-reactivity was observed with 29 non-target respiratory pathogens. These findings demonstrate that the cobas assay reliably detects SARS-CoV-2 and influenza A/B with high sensitivity and specificity. Notably, this assay enables high-throughput automated workflows, facilitating timely decision-making during SARS-CoV-2 and influenza cocirculation.IMPORTANCEAccurate and rapid diagnostic assays that simultaneously detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and influenza A/B are essential for effective clinical management and infection control. This study demonstrates that the cobas SARS-CoV-2 & Influenza A/B v2 assay reliably detects SARS-CoV-2 and influenza A/B with high sensitivity and specificity. Designed for use on the cobas 5800/6800/8800 systems, this assay supports high-throughput automated workflows, enabling timely decision-making during periods of high testing demand, such as the cocirculation of SARS-CoV-2 and influenza.https://journals.asm.org/doi/10.1128/spectrum.01111-25SARS-CoV-2influenzacobas assayAllplex assay |
| spellingShingle | Eunjung Jeong Minhee Kang Hyeonseek Park Ji-Youn Kim Sun Ae Yun Yun Young Cho Jae-Hoon Ko Tae Yeul Kim Hee Jae Huh Nam Yong Lee Evaluation of the cobas SARS-CoV-2 & Influenza A/B v2 assay for detecting SARS-CoV-2 and influenza A and B viruses in nasopharyngeal swab specimens Microbiology Spectrum SARS-CoV-2 influenza cobas assay Allplex assay |
| title | Evaluation of the cobas SARS-CoV-2 & Influenza A/B v2 assay for detecting SARS-CoV-2 and influenza A and B viruses in nasopharyngeal swab specimens |
| title_full | Evaluation of the cobas SARS-CoV-2 & Influenza A/B v2 assay for detecting SARS-CoV-2 and influenza A and B viruses in nasopharyngeal swab specimens |
| title_fullStr | Evaluation of the cobas SARS-CoV-2 & Influenza A/B v2 assay for detecting SARS-CoV-2 and influenza A and B viruses in nasopharyngeal swab specimens |
| title_full_unstemmed | Evaluation of the cobas SARS-CoV-2 & Influenza A/B v2 assay for detecting SARS-CoV-2 and influenza A and B viruses in nasopharyngeal swab specimens |
| title_short | Evaluation of the cobas SARS-CoV-2 & Influenza A/B v2 assay for detecting SARS-CoV-2 and influenza A and B viruses in nasopharyngeal swab specimens |
| title_sort | evaluation of the cobas sars cov 2 influenza a b v2 assay for detecting sars cov 2 and influenza a and b viruses in nasopharyngeal swab specimens |
| topic | SARS-CoV-2 influenza cobas assay Allplex assay |
| url | https://journals.asm.org/doi/10.1128/spectrum.01111-25 |
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