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A Prospective Evaluation of the Analytical Performance of GENECUBE(®) HQ SARS-CoV-2 and GENECUBE(®) FLU A/B
BACKGROUND: Molecular tests are the mainstay of detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). However, their accessibility can be limited by the long examination time and inability to evaluate multiple samples at once. OBJECTIVE: This study evaluated the analytical performa...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8129955/ https://www.ncbi.nlm.nih.gov/pubmed/34003471 http://dx.doi.org/10.1007/s40291-021-00535-5 |
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author | Kiyasu, Yoshihiko Akashi, Yusaku Sugiyama, Akio Takeuchi, Yuto Notake, Shigeyuki Naito, Asami Nakamura, Koji Ishikawa, Hiroichi Suzuki, Hiromichi |
author_facet | Kiyasu, Yoshihiko Akashi, Yusaku Sugiyama, Akio Takeuchi, Yuto Notake, Shigeyuki Naito, Asami Nakamura, Koji Ishikawa, Hiroichi Suzuki, Hiromichi |
author_sort | Kiyasu, Yoshihiko |
collection | PubMed |
description | BACKGROUND: Molecular tests are the mainstay of detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). However, their accessibility can be limited by the long examination time and inability to evaluate multiple samples at once. OBJECTIVE: This study evaluated the analytical performance of the newly developed rapid molecular assays GENECUBE(®) HQ SARS-CoV-2 and GENECUBE(®) FLU A/B. METHOD: This prospective study was conducted between 14 December 2020 and 9 January 2021 at a polymerase chain reaction (PCR) center. Samples were collected from the nasopharynx with flocked swabs. Molecular tests were performed with the GENECUBE(®) system and reference reverse transcription (RT)-PCR, and the results of the two assays were compared. RESULT: Among 1065 samples, 81 (7.6%) were positive for SARS-CoV-2 on the reference RT-PCR. Three showed discordance between GENECUBE(®) HQ SARS-CoV-2 and the reference RT-PCR; the total, positive, and negative samples of concordance for the two assays were 99.7%, 100%, and 99.7%, respectively. All discordant cases were positive with GENECUBE(®) HQ SARS-CoV-2 and negative with the reference RT-PCR. SARS-CoV-2 was detected in all three samples using another molecular assay for SARS-CoV-2. For GENECUBE(®) FLU A/B, the total, positive, and negative samples of concordance for the two assays were 99.5%, 100%, and 99.1%. CONCLUSION: The GENECUBE(®) HQ SARS-CoV-2 and GENECUBE(®) FLU A/B demonstrated sufficient analytical performance to detect SARS-CoV-2 and influenza virus A/B. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40291-021-00535-5. |
format | Online Article Text |
id | pubmed-8129955 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Springer International Publishing |
record_format | MEDLINE/PubMed |
spelling | pubmed-81299552021-05-18 A Prospective Evaluation of the Analytical Performance of GENECUBE(®) HQ SARS-CoV-2 and GENECUBE(®) FLU A/B Kiyasu, Yoshihiko Akashi, Yusaku Sugiyama, Akio Takeuchi, Yuto Notake, Shigeyuki Naito, Asami Nakamura, Koji Ishikawa, Hiroichi Suzuki, Hiromichi Mol Diagn Ther Original Research Article BACKGROUND: Molecular tests are the mainstay of detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). However, their accessibility can be limited by the long examination time and inability to evaluate multiple samples at once. OBJECTIVE: This study evaluated the analytical performance of the newly developed rapid molecular assays GENECUBE(®) HQ SARS-CoV-2 and GENECUBE(®) FLU A/B. METHOD: This prospective study was conducted between 14 December 2020 and 9 January 2021 at a polymerase chain reaction (PCR) center. Samples were collected from the nasopharynx with flocked swabs. Molecular tests were performed with the GENECUBE(®) system and reference reverse transcription (RT)-PCR, and the results of the two assays were compared. RESULT: Among 1065 samples, 81 (7.6%) were positive for SARS-CoV-2 on the reference RT-PCR. Three showed discordance between GENECUBE(®) HQ SARS-CoV-2 and the reference RT-PCR; the total, positive, and negative samples of concordance for the two assays were 99.7%, 100%, and 99.7%, respectively. All discordant cases were positive with GENECUBE(®) HQ SARS-CoV-2 and negative with the reference RT-PCR. SARS-CoV-2 was detected in all three samples using another molecular assay for SARS-CoV-2. For GENECUBE(®) FLU A/B, the total, positive, and negative samples of concordance for the two assays were 99.5%, 100%, and 99.1%. CONCLUSION: The GENECUBE(®) HQ SARS-CoV-2 and GENECUBE(®) FLU A/B demonstrated sufficient analytical performance to detect SARS-CoV-2 and influenza virus A/B. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40291-021-00535-5. Springer International Publishing 2021-05-18 2021 /pmc/articles/PMC8129955/ /pubmed/34003471 http://dx.doi.org/10.1007/s40291-021-00535-5 Text en © The Author(s), under exclusive licence to Springer Nature Switzerland AG 2021 This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic. |
spellingShingle | Original Research Article Kiyasu, Yoshihiko Akashi, Yusaku Sugiyama, Akio Takeuchi, Yuto Notake, Shigeyuki Naito, Asami Nakamura, Koji Ishikawa, Hiroichi Suzuki, Hiromichi A Prospective Evaluation of the Analytical Performance of GENECUBE(®) HQ SARS-CoV-2 and GENECUBE(®) FLU A/B |
title | A Prospective Evaluation of the Analytical Performance of GENECUBE(®) HQ SARS-CoV-2 and GENECUBE(®) FLU A/B |
title_full | A Prospective Evaluation of the Analytical Performance of GENECUBE(®) HQ SARS-CoV-2 and GENECUBE(®) FLU A/B |
title_fullStr | A Prospective Evaluation of the Analytical Performance of GENECUBE(®) HQ SARS-CoV-2 and GENECUBE(®) FLU A/B |
title_full_unstemmed | A Prospective Evaluation of the Analytical Performance of GENECUBE(®) HQ SARS-CoV-2 and GENECUBE(®) FLU A/B |
title_short | A Prospective Evaluation of the Analytical Performance of GENECUBE(®) HQ SARS-CoV-2 and GENECUBE(®) FLU A/B |
title_sort | prospective evaluation of the analytical performance of genecube(®) hq sars-cov-2 and genecube(®) flu a/b |
topic | Original Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8129955/ https://www.ncbi.nlm.nih.gov/pubmed/34003471 http://dx.doi.org/10.1007/s40291-021-00535-5 |
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