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A rapid lateral flow immunoassay strip for detection of SARS‐CoV‐2 antigen using latex microspheres

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) is a highly infectious and concealed virus that causes pneumonia, severe acute respiratory syndrome, and even death. Although the epidemic has been controlled since the development of vaccines and quarantine measures, many peop...

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Autores principales: Shen, Lin, Zhang, Qihan, Luo, Xiaolu, Xiao, Haolin, Gu, Miao, Cao, Liangli, Zhao, Feijun, Chen, Zhencheng
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8646881/
https://www.ncbi.nlm.nih.gov/pubmed/34741352
http://dx.doi.org/10.1002/jcla.24091
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author Shen, Lin
Zhang, Qihan
Luo, Xiaolu
Xiao, Haolin
Gu, Miao
Cao, Liangli
Zhao, Feijun
Chen, Zhencheng
author_facet Shen, Lin
Zhang, Qihan
Luo, Xiaolu
Xiao, Haolin
Gu, Miao
Cao, Liangli
Zhao, Feijun
Chen, Zhencheng
author_sort Shen, Lin
collection PubMed
description BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) is a highly infectious and concealed virus that causes pneumonia, severe acute respiratory syndrome, and even death. Although the epidemic has been controlled since the development of vaccines and quarantine measures, many people are still infected, particularly in third‐world countries. Several methods have been developed for detection of SARS‐CoV‐2, but owing to its price and efficiency, the immune strip could be a better method for the third‐world countries. METHODS: In this study, two antibodies were linked to latex microspheres, using 1‐(3‐dimethylaminopropyl)‐3‐ethylcarbodiimide hydrochloride and N‐hydroxysuccinimide, as the bridge to decrease the cost further and improve the detection performance. The specificity of the lateral flow immunoassay strip (LFIA) was tested by several common viruses and respiratory bacterial infections. Besides, the reproducibility and stability of the LFIAs were tested on the same batch of test strips. Under optimal conditions, the sensitivity of LFIA was determined by testing different dilutions of the positive specimens. RESULTS: The proposed LFIAs were highly specific, and the limit of detection was as low as 25 ng/mL for SARS‐CoV‐2 antigens. The clinical applicability was evaluated with 659 samples (230 positive and 429 negative samples) by using both LFIA and rRT‐PCR. Youden’s index (J) was used to assess the performance of these diagnostic tests. The sensitivity and specificity were 98.22% and 97.93%, respectively, and J is 0.9615. The sensitivity and specificity were 98.22% and 97.93%, respectively, and J is 0.9615. In addition, the consistency of our proposed LFIA was analyzed using Cohen's kappa coefficient (κ = 0.9620). CONCLUSION: We found disease stage, age, gender, and clinical manifestations have only a slight influence on the diagnosis. Therefore, the lateral flow immunoassay SARS‐CoV‐2 antigen test strip is suitable for point‐of‐care detection and provides a great application for SARS‐CoV‐2 epidemic control in the third‐world countries.
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spelling pubmed-86468812021-12-06 A rapid lateral flow immunoassay strip for detection of SARS‐CoV‐2 antigen using latex microspheres Shen, Lin Zhang, Qihan Luo, Xiaolu Xiao, Haolin Gu, Miao Cao, Liangli Zhao, Feijun Chen, Zhencheng J Clin Lab Anal Research Articles BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) is a highly infectious and concealed virus that causes pneumonia, severe acute respiratory syndrome, and even death. Although the epidemic has been controlled since the development of vaccines and quarantine measures, many people are still infected, particularly in third‐world countries. Several methods have been developed for detection of SARS‐CoV‐2, but owing to its price and efficiency, the immune strip could be a better method for the third‐world countries. METHODS: In this study, two antibodies were linked to latex microspheres, using 1‐(3‐dimethylaminopropyl)‐3‐ethylcarbodiimide hydrochloride and N‐hydroxysuccinimide, as the bridge to decrease the cost further and improve the detection performance. The specificity of the lateral flow immunoassay strip (LFIA) was tested by several common viruses and respiratory bacterial infections. Besides, the reproducibility and stability of the LFIAs were tested on the same batch of test strips. Under optimal conditions, the sensitivity of LFIA was determined by testing different dilutions of the positive specimens. RESULTS: The proposed LFIAs were highly specific, and the limit of detection was as low as 25 ng/mL for SARS‐CoV‐2 antigens. The clinical applicability was evaluated with 659 samples (230 positive and 429 negative samples) by using both LFIA and rRT‐PCR. Youden’s index (J) was used to assess the performance of these diagnostic tests. The sensitivity and specificity were 98.22% and 97.93%, respectively, and J is 0.9615. The sensitivity and specificity were 98.22% and 97.93%, respectively, and J is 0.9615. In addition, the consistency of our proposed LFIA was analyzed using Cohen's kappa coefficient (κ = 0.9620). CONCLUSION: We found disease stage, age, gender, and clinical manifestations have only a slight influence on the diagnosis. Therefore, the lateral flow immunoassay SARS‐CoV‐2 antigen test strip is suitable for point‐of‐care detection and provides a great application for SARS‐CoV‐2 epidemic control in the third‐world countries. John Wiley and Sons Inc. 2021-11-06 /pmc/articles/PMC8646881/ /pubmed/34741352 http://dx.doi.org/10.1002/jcla.24091 Text en © 2021 The Authors. Journal of Clinical Laboratory Analysis published by Wiley Periodicals LLC. https://creativecommons.org/licenses/by/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research Articles
Shen, Lin
Zhang, Qihan
Luo, Xiaolu
Xiao, Haolin
Gu, Miao
Cao, Liangli
Zhao, Feijun
Chen, Zhencheng
A rapid lateral flow immunoassay strip for detection of SARS‐CoV‐2 antigen using latex microspheres
title A rapid lateral flow immunoassay strip for detection of SARS‐CoV‐2 antigen using latex microspheres
title_full A rapid lateral flow immunoassay strip for detection of SARS‐CoV‐2 antigen using latex microspheres
title_fullStr A rapid lateral flow immunoassay strip for detection of SARS‐CoV‐2 antigen using latex microspheres
title_full_unstemmed A rapid lateral flow immunoassay strip for detection of SARS‐CoV‐2 antigen using latex microspheres
title_short A rapid lateral flow immunoassay strip for detection of SARS‐CoV‐2 antigen using latex microspheres
title_sort rapid lateral flow immunoassay strip for detection of sars‐cov‐2 antigen using latex microspheres
topic Research Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8646881/
https://www.ncbi.nlm.nih.gov/pubmed/34741352
http://dx.doi.org/10.1002/jcla.24091
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