Comparative Evaluation of the Diagnostic Performance of the Prototype Cepheid GeneXpert Ebola Assay

Abstract

The diagnostic sensitivity of the three platforms was 100% in 91 patient samples that were confirmed to be infectious by virus isolation. All three molecular platforms detected viral EBOV RNA in additional samples that did not contain viable EBOV. The analytical sensitivity of the GeneXpert Ebola POC for the detection of NP was higher, and comparable to that of polymerase gene detection, than that for the detection of GP when using a titrated laboratory stock of EBOV. There was no detectable cross-reactivity with other hemorrhagic fever viruses or arboviruses. The GeneXpert Ebola POC offers an easy to operate and sensitive diagnostic tool that can be used for the rapid screening of suspected EVD cases in treatment or in holding centers during EVD outbreaks.

Diagnosis of Ebola Virus Disease: Past, Present, and Future

“…The analytic and clinical performance characteristics of the Xpert Ebola assay were further evaluated at the NICD in South Africa (72). This study presented a comparison of results obtained from the Xpert Ebola assay and a laboratory-developed real-time RT-PCR assay (L gene target) performed on 281 frozen serum and plasma samples collected from EVD suspect patients in Sierra Leone.…”

Ebola virus disease and pregnancy: A review of the current knowledge of Ebola virus pathogenesis, maternal, and neonatal outcomes

“…New point-of-care diagnostics with sensitivity and specificity comparable to traditional RT-PCR techniques have been developed and are being tested (WHO, 2015a;van Vuren et al, 2015). Irrespective of test type, EVD diagnosis often requires blood testing, which carries a risk of viral exposure for those performing venipuncture.…”

Bolstering Community Cooperation in Ebola Resurgence Protocols: Combining Field Blood Draw and Point-of-Care Diagnosis

“…Traditionally, diagnosis of EVD involves real-time reverse transcription-PCR (RT-PCR) assays, which require 2 to 6 hours once a sample is received [21–24]. In 2015, the United States Food and Drug Administration and the WHO authorized emergency use of the Cepheid GeneXpert Ebola assay, a point-of-care diagnostic test that uses whole blood versus serum or plasma and accelerates results [26–28].…”

“…In 2015, the United States Food and Drug Administration and the WHO authorized emergency use of the Cepheid GeneXpert Ebola assay, a point-of-care diagnostic test that uses whole blood versus serum or plasma and accelerates results [26–28]. The sensitivity and specificity of the assay are comparable to those of the standard real-time RT-PCR, with enhanced sensitivity for the nucleoprotein target [21,26]. Specifically, compared to the benchmark Trombley real-time RT-PCR (rRT-PCR) assay for detection of the nucleoprotein of the Ebola virus [29], sensitivity and specificity on whole blood samples were found to be 100% (95% CI: 84.6%–100%) and 95.8% (95% CI: 91.8%–98.2%), respectively, for GeneXpert [26].…”