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Prospective study of 1308 nasopharyngeal swabs from 1033 patients using the LUMIPULSE SARS-CoV-2 antigen test: Comparison with RT-qPCR

BACKGROUND: Reverse transcription polymerase chain reaction (RT-PCR) is the gold standard for detection of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). Previously, the accuracy of the quantitative LUMIPULSE SARS-CoV-2 antigen test was demonstrated using samples collected retrospecti...

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Autores principales: Hirotsu, Yosuke, Maejima, Makoto, Shibusawa, Masahiro, Amemiya, Kenji, Nagakubo, Yuki, Hosaka, Kazuhiro, Sueki, Hitomi, Hayakawa, Miyoko, Mochizuki, Hitoshi, Tsutsui, Toshiharu, Kakizaki, Yumiko, Miyashita, Yoshihiro, Omata, Masao
Formato: Online Artículo Texto
Lenguaje:English
Publicado: The Author(s). Published by Elsevier Ltd on behalf of International Society for Infectious Diseases. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7863769/
https://www.ncbi.nlm.nih.gov/pubmed/33556612
http://dx.doi.org/10.1016/j.ijid.2021.02.005
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author Hirotsu, Yosuke
Maejima, Makoto
Shibusawa, Masahiro
Amemiya, Kenji
Nagakubo, Yuki
Hosaka, Kazuhiro
Sueki, Hitomi
Hayakawa, Miyoko
Mochizuki, Hitoshi
Tsutsui, Toshiharu
Kakizaki, Yumiko
Miyashita, Yoshihiro
Omata, Masao
author_facet Hirotsu, Yosuke
Maejima, Makoto
Shibusawa, Masahiro
Amemiya, Kenji
Nagakubo, Yuki
Hosaka, Kazuhiro
Sueki, Hitomi
Hayakawa, Miyoko
Mochizuki, Hitoshi
Tsutsui, Toshiharu
Kakizaki, Yumiko
Miyashita, Yoshihiro
Omata, Masao
author_sort Hirotsu, Yosuke
collection PubMed
description BACKGROUND: Reverse transcription polymerase chain reaction (RT-PCR) is the gold standard for detection of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). Previously, the accuracy of the quantitative LUMIPULSE SARS-CoV-2 antigen test was demonstrated using samples collected retrospectively. In this study, the LUMIPULSE antigen test was clinically validated using prospective samples. METHODS: In total, 1033 nasopharyngeal swab samples were collected from 1033 individuals, and an additional 275 follow-up samples were collected from 43 patients who subsequently tested positive for coronavirus disease 2019 (COVID-19). All 1308 samples were subjected to quantitative RT-PCR (RT-qPCR) and the antigen test. The antibody response was investigated for patients with discordant results to clarify if seroconversion had occurred. RESULTS: RT-qPCR identified 990 samples as negative and 43 as positive, while the antigen test identified 992 samples as negative, 37 as positive and four as inconclusive. The overall concordance rate was 99.7% (1026/1029). Sensitivity, specificity, positive predictive value and negative predictive value of the antigen test were 92.5% (37/40), 100% (989/989), 100% (37/37) and 99.7% (989/992), respectively, after exclusion of the four inconclusive results. The kappa coefficient was 0.960 (95% confidence interval 0.892–0.960), suggesting excellent agreement between the two tests. Seropositivity in five of seven patients with discordant results suggested that the discrepancy was caused by samples collected during the late phase of infection. Using follow-up samples, correlation was observed between the antigen level and the viral load or cycle threshold value. The concordance rate between these test results tended to be high among samples collected 0–9 days after symptom onset, but this decreased gradually in samples collected thereafter. CONCLUSIONS: This prospective study demonstrated that the LUMIPULSE antigen test is a highly accurate diagnostic test for SARS-CoV-2.
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spelling pubmed-78637692021-02-09 Prospective study of 1308 nasopharyngeal swabs from 1033 patients using the LUMIPULSE SARS-CoV-2 antigen test: Comparison with RT-qPCR Hirotsu, Yosuke Maejima, Makoto Shibusawa, Masahiro Amemiya, Kenji Nagakubo, Yuki Hosaka, Kazuhiro Sueki, Hitomi Hayakawa, Miyoko Mochizuki, Hitoshi Tsutsui, Toshiharu Kakizaki, Yumiko Miyashita, Yoshihiro Omata, Masao Int J Infect Dis Article BACKGROUND: Reverse transcription polymerase chain reaction (RT-PCR) is the gold standard for detection of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). Previously, the accuracy of the quantitative LUMIPULSE SARS-CoV-2 antigen test was demonstrated using samples collected retrospectively. In this study, the LUMIPULSE antigen test was clinically validated using prospective samples. METHODS: In total, 1033 nasopharyngeal swab samples were collected from 1033 individuals, and an additional 275 follow-up samples were collected from 43 patients who subsequently tested positive for coronavirus disease 2019 (COVID-19). All 1308 samples were subjected to quantitative RT-PCR (RT-qPCR) and the antigen test. The antibody response was investigated for patients with discordant results to clarify if seroconversion had occurred. RESULTS: RT-qPCR identified 990 samples as negative and 43 as positive, while the antigen test identified 992 samples as negative, 37 as positive and four as inconclusive. The overall concordance rate was 99.7% (1026/1029). Sensitivity, specificity, positive predictive value and negative predictive value of the antigen test were 92.5% (37/40), 100% (989/989), 100% (37/37) and 99.7% (989/992), respectively, after exclusion of the four inconclusive results. The kappa coefficient was 0.960 (95% confidence interval 0.892–0.960), suggesting excellent agreement between the two tests. Seropositivity in five of seven patients with discordant results suggested that the discrepancy was caused by samples collected during the late phase of infection. Using follow-up samples, correlation was observed between the antigen level and the viral load or cycle threshold value. The concordance rate between these test results tended to be high among samples collected 0–9 days after symptom onset, but this decreased gradually in samples collected thereafter. CONCLUSIONS: This prospective study demonstrated that the LUMIPULSE antigen test is a highly accurate diagnostic test for SARS-CoV-2. The Author(s). Published by Elsevier Ltd on behalf of International Society for Infectious Diseases. 2021-04 2021-02-05 /pmc/articles/PMC7863769/ /pubmed/33556612 http://dx.doi.org/10.1016/j.ijid.2021.02.005 Text en © 2021 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
Amemiya, Kenji
Nagakubo, Yuki
Hosaka, Kazuhiro
Sueki, Hitomi
Hayakawa, Miyoko
Mochizuki, Hitoshi
Tsutsui, Toshiharu
Kakizaki, Yumiko
Miyashita, Yoshihiro
Omata, Masao
Prospective study of 1308 nasopharyngeal swabs from 1033 patients using the LUMIPULSE SARS-CoV-2 antigen test: Comparison with RT-qPCR
title Prospective study of 1308 nasopharyngeal swabs from 1033 patients using the LUMIPULSE SARS-CoV-2 antigen test: Comparison with RT-qPCR
title_full Prospective study of 1308 nasopharyngeal swabs from 1033 patients using the LUMIPULSE SARS-CoV-2 antigen test: Comparison with RT-qPCR
title_fullStr Prospective study of 1308 nasopharyngeal swabs from 1033 patients using the LUMIPULSE SARS-CoV-2 antigen test: Comparison with RT-qPCR
title_full_unstemmed Prospective study of 1308 nasopharyngeal swabs from 1033 patients using the LUMIPULSE SARS-CoV-2 antigen test: Comparison with RT-qPCR
title_short Prospective study of 1308 nasopharyngeal swabs from 1033 patients using the LUMIPULSE SARS-CoV-2 antigen test: Comparison with RT-qPCR
title_sort prospective study of 1308 nasopharyngeal swabs from 1033 patients using the lumipulse sars-cov-2 antigen test: comparison with rt-qpcr
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7863769/
https://www.ncbi.nlm.nih.gov/pubmed/33556612
http://dx.doi.org/10.1016/j.ijid.2021.02.005
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