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Comparison of automated SARS-CoV-2 antigen test for COVID-19 infection with quantitative RT-PCR using 313 nasopharyngeal swabs, including from seven serially followed patients
In routine clinical practice, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is determined by reverse-transcription PCR (RT-PCR). In the current pandemic, a more rapid and high-throughput method is in growing demand. Here, we validated the performance of a new antigen test (L...
Autores principales: | , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
The Author(s). Published by Elsevier Ltd on behalf of International Society for Infectious Diseases.
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7422837/ https://www.ncbi.nlm.nih.gov/pubmed/32800855 http://dx.doi.org/10.1016/j.ijid.2020.08.029 |
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author | Hirotsu, Yosuke Maejima, Makoto Shibusawa, Masahiro Nagakubo, Yuki Hosaka, Kazuhiro Amemiya, Kenji Sueki, Hitomi Hayakawa, Miyoko Mochizuki, Hitoshi Tsutsui, Toshiharu Kakizaki, Yumiko Miyashita, Yoshihiro Yagi, Shintaro Kojima, Satoshi Omata, Masao |
author_facet | Hirotsu, Yosuke Maejima, Makoto Shibusawa, Masahiro Nagakubo, Yuki Hosaka, Kazuhiro Amemiya, Kenji Sueki, Hitomi Hayakawa, Miyoko Mochizuki, Hitoshi Tsutsui, Toshiharu Kakizaki, Yumiko Miyashita, Yoshihiro Yagi, Shintaro Kojima, Satoshi Omata, Masao |
author_sort | Hirotsu, Yosuke |
collection | PubMed |
description | In routine clinical practice, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is determined by reverse-transcription PCR (RT-PCR). In the current pandemic, a more rapid and high-throughput method is in growing demand. Here, we validated the performance of a new antigen test (LUMIPULSE) based on chemiluminescence enzyme immunoassay. A total of 313 nasopharyngeal swabs (82 serial samples from 7 infected patients and 231 individual samples from 4 infected patients and 215 uninfected individuals) were analyzed for SARS-CoV-2 with quantitative RT-PCR (RT-qPCR) and then subjected to LUMIPULSE. We determined the cutoff value for antigen detection using receiver operating characteristic curve analysis and compared the performance of the antigen test with that of RT-qPCR. We also compared the viral loads and antigen levels in serial samples from seven infected patients. Using RT-qPCR as the reference, the antigen test exhibited 55.2% sensitivity and 99.6% specificity, with a 91.4% overall agreement rate (286/313). In specimens with > 100 viral copies and between 10 and 100 copies, the antigen test showed 100% and 85% concordance with RT-qPCR, respectively. This concordance declined with lower viral loads. In the serially followed patients, the antigen levels showed a steady decline, along with viral clearance. This gradual decline was in contrast with the abrupt positive-to-negative and negative-to-positive status changes observed with RT-qPCR, particularly in the late phase of infection. In summary, the LUMIPULSE antigen test can rapidly identify SARS-CoV-2-infected individuals with moderate to high viral loads and may be helpful for monitoring viral clearance in hospitalized patients. |
format | Online Article Text |
id | pubmed-7422837 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | The Author(s). Published by Elsevier Ltd on behalf of International Society for Infectious Diseases. |
record_format | MEDLINE/PubMed |
spelling | pubmed-74228372020-08-13 Comparison of automated SARS-CoV-2 antigen test for COVID-19 infection with quantitative RT-PCR using 313 nasopharyngeal swabs, including from seven serially followed patients Hirotsu, Yosuke Maejima, Makoto Shibusawa, Masahiro Nagakubo, Yuki Hosaka, Kazuhiro Amemiya, Kenji Sueki, Hitomi Hayakawa, Miyoko Mochizuki, Hitoshi Tsutsui, Toshiharu Kakizaki, Yumiko Miyashita, Yoshihiro Yagi, Shintaro Kojima, Satoshi Omata, Masao Int J Infect Dis Article In routine clinical practice, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is determined by reverse-transcription PCR (RT-PCR). In the current pandemic, a more rapid and high-throughput method is in growing demand. Here, we validated the performance of a new antigen test (LUMIPULSE) based on chemiluminescence enzyme immunoassay. A total of 313 nasopharyngeal swabs (82 serial samples from 7 infected patients and 231 individual samples from 4 infected patients and 215 uninfected individuals) were analyzed for SARS-CoV-2 with quantitative RT-PCR (RT-qPCR) and then subjected to LUMIPULSE. We determined the cutoff value for antigen detection using receiver operating characteristic curve analysis and compared the performance of the antigen test with that of RT-qPCR. We also compared the viral loads and antigen levels in serial samples from seven infected patients. Using RT-qPCR as the reference, the antigen test exhibited 55.2% sensitivity and 99.6% specificity, with a 91.4% overall agreement rate (286/313). In specimens with > 100 viral copies and between 10 and 100 copies, the antigen test showed 100% and 85% concordance with RT-qPCR, respectively. This concordance declined with lower viral loads. In the serially followed patients, the antigen levels showed a steady decline, along with viral clearance. This gradual decline was in contrast with the abrupt positive-to-negative and negative-to-positive status changes observed with RT-qPCR, particularly in the late phase of infection. In summary, the LUMIPULSE antigen test can rapidly identify SARS-CoV-2-infected individuals with moderate to high viral loads and may be helpful for monitoring viral clearance in hospitalized patients. The Author(s). Published by Elsevier Ltd on behalf of International Society for Infectious Diseases. 2020-10 2020-08-12 /pmc/articles/PMC7422837/ /pubmed/32800855 http://dx.doi.org/10.1016/j.ijid.2020.08.029 Text en © 2020 The Author(s) 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 | Article Hirotsu, Yosuke Maejima, Makoto Shibusawa, Masahiro Nagakubo, Yuki Hosaka, Kazuhiro Amemiya, Kenji Sueki, Hitomi Hayakawa, Miyoko Mochizuki, Hitoshi Tsutsui, Toshiharu Kakizaki, Yumiko Miyashita, Yoshihiro Yagi, Shintaro Kojima, Satoshi Omata, Masao Comparison of automated SARS-CoV-2 antigen test for COVID-19 infection with quantitative RT-PCR using 313 nasopharyngeal swabs, including from seven serially followed patients |
title | Comparison of automated SARS-CoV-2 antigen test for COVID-19 infection with quantitative RT-PCR using 313 nasopharyngeal swabs, including from seven serially followed patients |
title_full | Comparison of automated SARS-CoV-2 antigen test for COVID-19 infection with quantitative RT-PCR using 313 nasopharyngeal swabs, including from seven serially followed patients |
title_fullStr | Comparison of automated SARS-CoV-2 antigen test for COVID-19 infection with quantitative RT-PCR using 313 nasopharyngeal swabs, including from seven serially followed patients |
title_full_unstemmed | Comparison of automated SARS-CoV-2 antigen test for COVID-19 infection with quantitative RT-PCR using 313 nasopharyngeal swabs, including from seven serially followed patients |
title_short | Comparison of automated SARS-CoV-2 antigen test for COVID-19 infection with quantitative RT-PCR using 313 nasopharyngeal swabs, including from seven serially followed patients |
title_sort | comparison of automated sars-cov-2 antigen test for covid-19 infection with quantitative rt-pcr using 313 nasopharyngeal swabs, including from seven serially followed patients |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7422837/ https://www.ncbi.nlm.nih.gov/pubmed/32800855 http://dx.doi.org/10.1016/j.ijid.2020.08.029 |
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