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Sci Rep. 2016 Jun 1;6:26943. doi: 10.1038/srep26943.

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

Yang M1, Ke Y1,2, Wang X1,2, Ren H1, Liu W1,2, Lu H2,3, Zhang W1,2, Liu S4, Chang G1,2, Tian S1,2, Wang L2,5, Huang L1, Liu C1,2, Yang R2,6,7, Chen Z1,2,8.

Author information

1
Institute of Disease Control and Prevention, Academy of Military Medical Sciences, 100071, Beijing, China.
2
China Mobile Laboratory Response Team for Ebola in Sierra Leone, Freetown, Sierra Leone.
3
Key Laboratory of Jilin Province for Zoonosis Prevention and Control, Changchun 130122, China.
4
Wangjing Hospital, China Academy of Traditional Chinese Medicine, 100102, Beijing, China.
5
Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing 102206, China.
6
State Key Laboratory of Pathogen and Biosecurity, 100071, Beijing, China.
7
Beijing Key Laboratory of POCT for Bioemergency and Clinics, 100071, Beijing, China.
8
Key Laboratory of Zoonosis of Liaoning Province, College of Animal Science and Veterinary Medicine, Shenyang Agriculture University, 110866, Shenyang, China.

Abstract

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.

PMID:
27246147
PMCID:
PMC4887875
DOI:
10.1038/srep26943
[Indexed for MEDLINE]
Free PMC Article

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