Cargando…
Evaluation of the QIAstat-Dx Respiratory SARS-CoV-2 panel, a rapid multiplex PCR method for the diagnosis of COVID-19
INTRODUCTION: Rapid, simple, and accurate methods are required to diagnose coronavirus disease 2019 (COVID-19), which is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This study aimed to evaluate the performance of the QIAstat-Dx Respiratory SARS-CoV-2 Panel (QIAstat-SARS-C...
Autores principales: | , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd.
2022
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8825349/ https://www.ncbi.nlm.nih.gov/pubmed/35184977 http://dx.doi.org/10.1016/j.jiac.2022.02.004 |
_version_ | 1784647189114388480 |
---|---|
author | Ishikane, Masahiro Unoki-Kubota, Hiroyuki Moriya, Ataru Kutsuna, Satoshi Ando, Honami Kaburagi, Yasushi Suzuki, Tetsuya Iwamoto, Noriko Kimura, Moto Ohmagari, Norio |
author_facet | Ishikane, Masahiro Unoki-Kubota, Hiroyuki Moriya, Ataru Kutsuna, Satoshi Ando, Honami Kaburagi, Yasushi Suzuki, Tetsuya Iwamoto, Noriko Kimura, Moto Ohmagari, Norio |
author_sort | Ishikane, Masahiro |
collection | PubMed |
description | INTRODUCTION: Rapid, simple, and accurate methods are required to diagnose coronavirus disease 2019 (COVID-19), which is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This study aimed to evaluate the performance of the QIAstat-Dx Respiratory SARS-CoV-2 Panel (QIAstat-SARS-CoV-2), a rapid multiplex PCR assay for SARS-CoV-2 detection. METHODS: Nasopharyngeal swabs (NPS) that were obtained from patients with COVID-19 who were diagnosed at the National Center for Global Health and Medicine were used in this study. When the NPS samples were found to be negative for SARS-CoV-2 after treatment, they were used as negative samples. We evaluated the performance of the QIAstat-SARS-CoV-2 comparing SARS-CoV-2 detection with the National Institute of Infectious Diseases in Japan-recommended real-time polymerase chain reaction (RT-PCR) method (NIID-RT-PCR). RESULTS: In total, 45 NPS samples were analyzed. The proportion of overall agreement between QIAstat-SARS-CoV-2 and NIID-RT-PCR on 45 samples was 91.0% with a sensitivity of 84.0% (21/25), specificity at 100% (20/20), negative predictive value at 83.3% (20/24), and positive predictive value at 100% (21/21). There were no patients with co-infections with pathogens other than SARS-CoV-2. CONCLUSIONS: QIAstat-SARS-CoV-2 showed a high agreement in comparison with the NIID-RT-PCR for the detection of SARS-CoV-2. The QIAstat-SARS-CoV-2 also provided a rapid and accurate diagnosis for COVID-19, even when the concurrent detection of other respiratory pathogens was desired, and therefore, has the potential to direct appropriate therapy and infection control precautions. |
format | Online Article Text |
id | pubmed-8825349 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. |
record_format | MEDLINE/PubMed |
spelling | pubmed-88253492022-02-09 Evaluation of the QIAstat-Dx Respiratory SARS-CoV-2 panel, a rapid multiplex PCR method for the diagnosis of COVID-19 Ishikane, Masahiro Unoki-Kubota, Hiroyuki Moriya, Ataru Kutsuna, Satoshi Ando, Honami Kaburagi, Yasushi Suzuki, Tetsuya Iwamoto, Noriko Kimura, Moto Ohmagari, Norio J Infect Chemother Original Article INTRODUCTION: Rapid, simple, and accurate methods are required to diagnose coronavirus disease 2019 (COVID-19), which is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This study aimed to evaluate the performance of the QIAstat-Dx Respiratory SARS-CoV-2 Panel (QIAstat-SARS-CoV-2), a rapid multiplex PCR assay for SARS-CoV-2 detection. METHODS: Nasopharyngeal swabs (NPS) that were obtained from patients with COVID-19 who were diagnosed at the National Center for Global Health and Medicine were used in this study. When the NPS samples were found to be negative for SARS-CoV-2 after treatment, they were used as negative samples. We evaluated the performance of the QIAstat-SARS-CoV-2 comparing SARS-CoV-2 detection with the National Institute of Infectious Diseases in Japan-recommended real-time polymerase chain reaction (RT-PCR) method (NIID-RT-PCR). RESULTS: In total, 45 NPS samples were analyzed. The proportion of overall agreement between QIAstat-SARS-CoV-2 and NIID-RT-PCR on 45 samples was 91.0% with a sensitivity of 84.0% (21/25), specificity at 100% (20/20), negative predictive value at 83.3% (20/24), and positive predictive value at 100% (21/21). There were no patients with co-infections with pathogens other than SARS-CoV-2. CONCLUSIONS: QIAstat-SARS-CoV-2 showed a high agreement in comparison with the NIID-RT-PCR for the detection of SARS-CoV-2. The QIAstat-SARS-CoV-2 also provided a rapid and accurate diagnosis for COVID-19, even when the concurrent detection of other respiratory pathogens was desired, and therefore, has the potential to direct appropriate therapy and infection control precautions. Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. 2022-06 2022-02-09 /pmc/articles/PMC8825349/ /pubmed/35184977 http://dx.doi.org/10.1016/j.jiac.2022.02.004 Text en © 2022 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved. Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active. |
spellingShingle | Original Article Ishikane, Masahiro Unoki-Kubota, Hiroyuki Moriya, Ataru Kutsuna, Satoshi Ando, Honami Kaburagi, Yasushi Suzuki, Tetsuya Iwamoto, Noriko Kimura, Moto Ohmagari, Norio Evaluation of the QIAstat-Dx Respiratory SARS-CoV-2 panel, a rapid multiplex PCR method for the diagnosis of COVID-19 |
title | Evaluation of the QIAstat-Dx Respiratory SARS-CoV-2 panel, a rapid multiplex PCR method for the diagnosis of COVID-19 |
title_full | Evaluation of the QIAstat-Dx Respiratory SARS-CoV-2 panel, a rapid multiplex PCR method for the diagnosis of COVID-19 |
title_fullStr | Evaluation of the QIAstat-Dx Respiratory SARS-CoV-2 panel, a rapid multiplex PCR method for the diagnosis of COVID-19 |
title_full_unstemmed | Evaluation of the QIAstat-Dx Respiratory SARS-CoV-2 panel, a rapid multiplex PCR method for the diagnosis of COVID-19 |
title_short | Evaluation of the QIAstat-Dx Respiratory SARS-CoV-2 panel, a rapid multiplex PCR method for the diagnosis of COVID-19 |
title_sort | evaluation of the qiastat-dx respiratory sars-cov-2 panel, a rapid multiplex pcr method for the diagnosis of covid-19 |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8825349/ https://www.ncbi.nlm.nih.gov/pubmed/35184977 http://dx.doi.org/10.1016/j.jiac.2022.02.004 |
work_keys_str_mv | AT ishikanemasahiro evaluationoftheqiastatdxrespiratorysarscov2panelarapidmultiplexpcrmethodforthediagnosisofcovid19 AT unokikubotahiroyuki evaluationoftheqiastatdxrespiratorysarscov2panelarapidmultiplexpcrmethodforthediagnosisofcovid19 AT moriyaataru evaluationoftheqiastatdxrespiratorysarscov2panelarapidmultiplexpcrmethodforthediagnosisofcovid19 AT kutsunasatoshi evaluationoftheqiastatdxrespiratorysarscov2panelarapidmultiplexpcrmethodforthediagnosisofcovid19 AT andohonami evaluationoftheqiastatdxrespiratorysarscov2panelarapidmultiplexpcrmethodforthediagnosisofcovid19 AT kaburagiyasushi evaluationoftheqiastatdxrespiratorysarscov2panelarapidmultiplexpcrmethodforthediagnosisofcovid19 AT suzukitetsuya evaluationoftheqiastatdxrespiratorysarscov2panelarapidmultiplexpcrmethodforthediagnosisofcovid19 AT iwamotonoriko evaluationoftheqiastatdxrespiratorysarscov2panelarapidmultiplexpcrmethodforthediagnosisofcovid19 AT kimuramoto evaluationoftheqiastatdxrespiratorysarscov2panelarapidmultiplexpcrmethodforthediagnosisofcovid19 AT ohmagarinorio evaluationoftheqiastatdxrespiratorysarscov2panelarapidmultiplexpcrmethodforthediagnosisofcovid19 |