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.
Highlights
The ongoing Ebola virus disease (EVD) outbreak in West Africa is the largest since its first discovery in 19761–3
The EBOV-RPA is based on recombinase polymerase amplification (RPA) technology[12,13], which is performed at a constant temperature and has a run time shorter than 15 min
The EBOV-RPA assay can be completed in 20 minutes
Summary
The ongoing Ebola virus disease (EVD) outbreak in West Africa is the largest since its first discovery in 19761–3. Due to the rapid progression to death and the long time required to obtain laboratory results, rapid diagnosis is extremely important for timely triage and treatment[8]. The diagnosis of EVD in West Africa involves the collection of blood and/or swab samples, transportation to the field laboratory, and testing by real-time RT-PCR. Samples from suspected patients are collected and sent to the laboratory for diagnosis confirmation. Despite positive predictive values (PPVs) of 100%, the sensitivity of the dipstick test is limited to samples with cycle threshold values
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