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Development and Evaluation of a Rapid and Sensitive EBOV-RPA Test for Rapid Diagnosis of Ebola Virus Disease

Confirming Ebola virus disease (EVD), a deadly infectious disease, requires real-time RT-PCR, which takes up to a few hours to yield results. Therefore, a rapid diagnostic assay is imperative for EVD diagnosis. A rapid nucleic acid test based on recombinase polymerase amplification (EBOV-RPA) was de...

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Autores principales: Yang, Mingjuan, Ke, Yuehua, Wang, Xuesong, Ren, Hang, Liu, Wei, Lu, Huijun, Zhang, Wenyi, Liu, Shiwei, Chang, Guohui, Tian, Shuguang, Wang, Lihua, Huang, Liuyu, Liu, Chao, Yang, Ruifu, Chen, Zeliang
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4887875/
https://www.ncbi.nlm.nih.gov/pubmed/27246147
http://dx.doi.org/10.1038/srep26943
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author Yang, Mingjuan
Ke, Yuehua
Wang, Xuesong
Ren, Hang
Liu, Wei
Lu, Huijun
Zhang, Wenyi
Liu, Shiwei
Chang, Guohui
Tian, Shuguang
Wang, Lihua
Huang, Liuyu
Liu, Chao
Yang, Ruifu
Chen, Zeliang
author_facet Yang, Mingjuan
Ke, Yuehua
Wang, Xuesong
Ren, Hang
Liu, Wei
Lu, Huijun
Zhang, Wenyi
Liu, Shiwei
Chang, Guohui
Tian, Shuguang
Wang, Lihua
Huang, Liuyu
Liu, Chao
Yang, Ruifu
Chen, Zeliang
author_sort Yang, Mingjuan
collection PubMed
description Confirming Ebola virus disease (EVD), a deadly infectious disease, requires real-time RT-PCR, which takes up to a few hours to yield results. Therefore, a rapid diagnostic assay is imperative for EVD diagnosis. A rapid nucleic acid test based on recombinase polymerase amplification (EBOV-RPA) was developed to specifically detect the 2014 outbreak strains. The EBOV-RPA assay was evaluated by testing samples from suspected EVD patients in parallel with RT-PCR. An EBOV-RPA, which could be completed in 20 min, was successfully developed. Of 271 patients who tested positive for Ebola virus by RT-PCR, 264 (sensitivity: 97%, 95% CI: 95.5–99.3%) were positive by EBOV-RPA; 101 of 104 patients (specificity: 97%, 95% CI: 93.9–100%) who tested negative by RT-PCR were also negative by EBOV-RPA. The sensitivity values for samples with a Ct value of <34, which accounted for 95.59% of the samples, was 100%. Discordant samples positive by RT-PCR but negative by EBOV-RPA had significantly high Ct values. Results of external quality assessment samples with EBOV-RPA were 100%, consistent with those of RT-PCR. The EBOV-RPA assay showed 97% sensitivity and 97% specificity for all EVD samples tested, making it a rapid and sensitive test for EVD diagnosis.
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spelling pubmed-48878752016-06-09 Development and Evaluation of a Rapid and Sensitive EBOV-RPA Test for Rapid Diagnosis of Ebola Virus Disease Yang, Mingjuan Ke, Yuehua Wang, Xuesong Ren, Hang Liu, Wei Lu, Huijun Zhang, Wenyi Liu, Shiwei Chang, Guohui Tian, Shuguang Wang, Lihua Huang, Liuyu Liu, Chao Yang, Ruifu Chen, Zeliang Sci Rep Article Confirming Ebola virus disease (EVD), a deadly infectious disease, requires real-time RT-PCR, which takes up to a few hours to yield results. Therefore, a rapid diagnostic assay is imperative for EVD diagnosis. A rapid nucleic acid test based on recombinase polymerase amplification (EBOV-RPA) was developed to specifically detect the 2014 outbreak strains. The EBOV-RPA assay was evaluated by testing samples from suspected EVD patients in parallel with RT-PCR. An EBOV-RPA, which could be completed in 20 min, was successfully developed. Of 271 patients who tested positive for Ebola virus by RT-PCR, 264 (sensitivity: 97%, 95% CI: 95.5–99.3%) were positive by EBOV-RPA; 101 of 104 patients (specificity: 97%, 95% CI: 93.9–100%) who tested negative by RT-PCR were also negative by EBOV-RPA. The sensitivity values for samples with a Ct value of <34, which accounted for 95.59% of the samples, was 100%. Discordant samples positive by RT-PCR but negative by EBOV-RPA had significantly high Ct values. Results of external quality assessment samples with EBOV-RPA were 100%, consistent with those of RT-PCR. The EBOV-RPA assay showed 97% sensitivity and 97% specificity for all EVD samples tested, making it a rapid and sensitive test for EVD diagnosis. Nature Publishing Group 2016-06-01 /pmc/articles/PMC4887875/ /pubmed/27246147 http://dx.doi.org/10.1038/srep26943 Text en Copyright © 2016, Macmillan Publishers Limited http://creativecommons.org/licenses/by/4.0/ This work is licensed under a Creative Commons Attribution 4.0 International License. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in the credit line; if the material is not included under the Creative Commons license, users will need to obtain permission from the license holder to reproduce the material. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/
spellingShingle Article
Yang, Mingjuan
Ke, Yuehua
Wang, Xuesong
Ren, Hang
Liu, Wei
Lu, Huijun
Zhang, Wenyi
Liu, Shiwei
Chang, Guohui
Tian, Shuguang
Wang, Lihua
Huang, Liuyu
Liu, Chao
Yang, Ruifu
Chen, Zeliang
Development and Evaluation of a Rapid and Sensitive EBOV-RPA Test for Rapid Diagnosis of Ebola Virus Disease
title Development and Evaluation of a Rapid and Sensitive EBOV-RPA Test for Rapid Diagnosis of Ebola Virus Disease
title_full Development and Evaluation of a Rapid and Sensitive EBOV-RPA Test for Rapid Diagnosis of Ebola Virus Disease
title_fullStr Development and Evaluation of a Rapid and Sensitive EBOV-RPA Test for Rapid Diagnosis of Ebola Virus Disease
title_full_unstemmed Development and Evaluation of a Rapid and Sensitive EBOV-RPA Test for Rapid Diagnosis of Ebola Virus Disease
title_short Development and Evaluation of a Rapid and Sensitive EBOV-RPA Test for Rapid Diagnosis of Ebola Virus Disease
title_sort development and evaluation of a rapid and sensitive ebov-rpa test for rapid diagnosis of ebola virus disease
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4887875/
https://www.ncbi.nlm.nih.gov/pubmed/27246147
http://dx.doi.org/10.1038/srep26943
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