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Evaluation of four commercial severe acute respiratory coronavirus 2 antibody tests

INTRODUCTION: Numerous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serological tests exists commercially; however, their performance using clinical samples is limited. Although insufficient to detect SARS-CoV-2 in the early phase of infection, antibody assays can be of great use for...

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Autores principales: Ashizawa, Nobuyuki, Takazono, Takahiro, Ohyama, Kaname, Nagasaki, Yoji, Okamoto, Masaki, Hirayama, Tatsuro, Takahashi, Kensuke, Yamanashi, Hirotomo, Tashiro, Masato, Hosogaya, Naoki, Tanaka, Takeshi, Yamamoto, Kazuko, Fukuda, Yuichi, Imamura, Yoshifumi, Kawanami, Toshinori, Miyazaki, Taiga, Sawai, Toyomitsu, Fukushima, Kiyoyasu, Yatera, Kazuhiro, Yanagihara, Katsunori, Izumikawa, Koichi, Mukae, Hiroshi
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7959261/
https://www.ncbi.nlm.nih.gov/pubmed/33781691
http://dx.doi.org/10.1016/j.jiac.2021.03.008
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author Ashizawa, Nobuyuki
Takazono, Takahiro
Ohyama, Kaname
Nagasaki, Yoji
Okamoto, Masaki
Hirayama, Tatsuro
Takahashi, Kensuke
Yamanashi, Hirotomo
Tashiro, Masato
Hosogaya, Naoki
Tanaka, Takeshi
Yamamoto, Kazuko
Fukuda, Yuichi
Imamura, Yoshifumi
Kawanami, Toshinori
Miyazaki, Taiga
Sawai, Toyomitsu
Fukushima, Kiyoyasu
Yatera, Kazuhiro
Yanagihara, Katsunori
Izumikawa, Koichi
Mukae, Hiroshi
author_facet Ashizawa, Nobuyuki
Takazono, Takahiro
Ohyama, Kaname
Nagasaki, Yoji
Okamoto, Masaki
Hirayama, Tatsuro
Takahashi, Kensuke
Yamanashi, Hirotomo
Tashiro, Masato
Hosogaya, Naoki
Tanaka, Takeshi
Yamamoto, Kazuko
Fukuda, Yuichi
Imamura, Yoshifumi
Kawanami, Toshinori
Miyazaki, Taiga
Sawai, Toyomitsu
Fukushima, Kiyoyasu
Yatera, Kazuhiro
Yanagihara, Katsunori
Izumikawa, Koichi
Mukae, Hiroshi
author_sort Ashizawa, Nobuyuki
collection PubMed
description INTRODUCTION: Numerous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serological tests exists commercially; however, their performance using clinical samples is limited. Although insufficient to detect SARS-CoV-2 in the early phase of infection, antibody assays can be of great use for surveillance studies or for some coronavirus disease 2019 (COVID-19) patients presenting late to the hospital. METHODS: This study evaluated the sensitivity and specificity of four commercial SARS-CoV-2 lateral flow antibody tests using 213 serum specimens from 90 PCR-positive confirmed COVID-19 patients. Of 59 negative control sera, 50 were obtained from patients with other respiratory infectious diseases before COVID-19 pandemic began while nine were from patients infected with other respiratory viruses, including two seasonal coronaviruses. RESULTS: The varied sensitivities for the four commercial kits were 70.9%, 65.3%, 45.1%, and 65.7% for BioMedomics, Autobio Diagnostics, Genbody, and KURABO, respectively, between sick days 1 and 155 in COVID-19 patients. The sensitivities of the four tests gradually increased over time after infection before sick day 5 (15.0%, 12.5%, 15.0%, and 20.0%); from sick day 11–15 (95.7%, 87.2%, 53.2%, and 89.4%); and after sick day 20 (100%, 100%, 68.6%, and 96.1%), respectively. For severe illness, the sensitivities were quite high in the late phase after sick day 15. The specificities were over 96% for all four tests. No cross-reaction due to other pathogens, including seasonal coronaviruses, was observed. CONCLUSIONS: Our results demonstrated the large differences in the antibody test performances. This ought to be considered when performing surveillance analysis.
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spelling pubmed-79592612021-03-16 Evaluation of four commercial severe acute respiratory coronavirus 2 antibody tests Ashizawa, Nobuyuki Takazono, Takahiro Ohyama, Kaname Nagasaki, Yoji Okamoto, Masaki Hirayama, Tatsuro Takahashi, Kensuke Yamanashi, Hirotomo Tashiro, Masato Hosogaya, Naoki Tanaka, Takeshi Yamamoto, Kazuko Fukuda, Yuichi Imamura, Yoshifumi Kawanami, Toshinori Miyazaki, Taiga Sawai, Toyomitsu Fukushima, Kiyoyasu Yatera, Kazuhiro Yanagihara, Katsunori Izumikawa, Koichi Mukae, Hiroshi J Infect Chemother Original Article INTRODUCTION: Numerous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serological tests exists commercially; however, their performance using clinical samples is limited. Although insufficient to detect SARS-CoV-2 in the early phase of infection, antibody assays can be of great use for surveillance studies or for some coronavirus disease 2019 (COVID-19) patients presenting late to the hospital. METHODS: This study evaluated the sensitivity and specificity of four commercial SARS-CoV-2 lateral flow antibody tests using 213 serum specimens from 90 PCR-positive confirmed COVID-19 patients. Of 59 negative control sera, 50 were obtained from patients with other respiratory infectious diseases before COVID-19 pandemic began while nine were from patients infected with other respiratory viruses, including two seasonal coronaviruses. RESULTS: The varied sensitivities for the four commercial kits were 70.9%, 65.3%, 45.1%, and 65.7% for BioMedomics, Autobio Diagnostics, Genbody, and KURABO, respectively, between sick days 1 and 155 in COVID-19 patients. The sensitivities of the four tests gradually increased over time after infection before sick day 5 (15.0%, 12.5%, 15.0%, and 20.0%); from sick day 11–15 (95.7%, 87.2%, 53.2%, and 89.4%); and after sick day 20 (100%, 100%, 68.6%, and 96.1%), respectively. For severe illness, the sensitivities were quite high in the late phase after sick day 15. The specificities were over 96% for all four tests. No cross-reaction due to other pathogens, including seasonal coronaviruses, was observed. CONCLUSIONS: Our results demonstrated the large differences in the antibody test performances. This ought to be considered when performing surveillance analysis. Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. 2021-07 2021-03-15 /pmc/articles/PMC7959261/ /pubmed/33781691 http://dx.doi.org/10.1016/j.jiac.2021.03.008 Text en © 2021 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
Ashizawa, Nobuyuki
Takazono, Takahiro
Ohyama, Kaname
Nagasaki, Yoji
Okamoto, Masaki
Hirayama, Tatsuro
Takahashi, Kensuke
Yamanashi, Hirotomo
Tashiro, Masato
Hosogaya, Naoki
Tanaka, Takeshi
Yamamoto, Kazuko
Fukuda, Yuichi
Imamura, Yoshifumi
Kawanami, Toshinori
Miyazaki, Taiga
Sawai, Toyomitsu
Fukushima, Kiyoyasu
Yatera, Kazuhiro
Yanagihara, Katsunori
Izumikawa, Koichi
Mukae, Hiroshi
Evaluation of four commercial severe acute respiratory coronavirus 2 antibody tests
title Evaluation of four commercial severe acute respiratory coronavirus 2 antibody tests
title_full Evaluation of four commercial severe acute respiratory coronavirus 2 antibody tests
title_fullStr Evaluation of four commercial severe acute respiratory coronavirus 2 antibody tests
title_full_unstemmed Evaluation of four commercial severe acute respiratory coronavirus 2 antibody tests
title_short Evaluation of four commercial severe acute respiratory coronavirus 2 antibody tests
title_sort evaluation of four commercial severe acute respiratory coronavirus 2 antibody tests
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7959261/
https://www.ncbi.nlm.nih.gov/pubmed/33781691
http://dx.doi.org/10.1016/j.jiac.2021.03.008
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