Evidence map›Paper›PMID 26562786›Full record

ArticlePloS one2015

Analytical Performance Characteristics of the Cepheid GeneXpert Ebola Assay for the Detection of Ebola Virus.

Benjamin A Pinsky, Malaya K Sahoo, Johanna Sandlund, Marika Kleman, Medha Kulkarni, Per Grufman, Malin Nygren, Robert Kwiatkowski, Ellen Jo Baron, Fred Tenover and 11 more

Erratum issued Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03767231 (Emergency Department Patient's Perceptions and Acceptability Toward a Novel Point-of-Care Hepatitis C Virus Viral Load Testing), which is not on this map. Cited by 31 papers.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed
4.9field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03767231 nanot yet recruitingnot on this mapstarted 2026, after this paper: background citation

Emergency Department Patient's Perceptions and Acceptability Toward a Novel Point-of-Care Hepatitis C Virus Viral Load Testing

TypeinterventionalSponsorJohns Hopkins UniversityRan2026 to 2027Enrolled200ConditionsHepatitis CArmsXpert HCV Viral Load Finger-stick Point-of-Care test (Cepheid)
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 55 citations in OpenAlex.

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  16. The current landscape of nucleic acid tests for filovirus detection.Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2018
    Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 5 institutions in 3 countries.

Benjamin A PinskyDepartment of Pathology, Stanford University School of Medicine, Stanford, California, United States of America.
Malaya K SahooDepartment of Pathology, Stanford University School of Medicine, Stanford, California, United States of America.
Johanna SandlundDepartment of Pathology, Stanford University School of Medicine, Stanford, California, United States of America.
Marika KlemanCepheid, Solna, Sweden.
Medha KulkarniCepheid, Sunnyvale, California, United States of America.
Per GrufmanCepheid, Solna, Sweden.
Malin NygrenCepheid, Solna, Sweden.
Robert KwiatkowskiCepheid, Sunnyvale, California, United States of America.
Ellen Jo BaronCepheid, Sunnyvale, California, United States of America.
Fred TenoverCepheid, Sunnyvale, California, United States of America.
Blake DenisonCepheid, Sunnyvale, California, United States of America.
Russell HiguchiCepheid, Sunnyvale, California, United States of America.
Reuel Van AttaCepheid, Sunnyvale, California, United States of America.
Neil Reginald BeerLawrence Livermore National Laboratory, Livermore, California, United States of America.
Alda Celena CarrilloLawrence Livermore National Laboratory, Livermore, California, United States of America.
Pejman Naraghi-AraniLawrence Livermore National Laboratory, Livermore, California, United States of America.
Chad E MireDepartment of Microbiology and Immunology, University of Texas Medical Branch, Galveston, Texas, United States of America.
Charlene RanadheeraSpecial Pathogens Program, National Microbiology Laboratory, Public Health Agency of Canada, Winnipeg, Manitoba, Canada.
Allen GrollaSpecial Pathogens Program, National Microbiology Laboratory, Public Health Agency of Canada, Winnipeg, Manitoba, Canada.
Nina LagerqvistThe Public Health Agency of Sweden, Solna, Sweden.
David H PersingCepheid, Sunnyvale, California, United States of America.
Lawrence Livermore National Laboratory · USStanford University · USPublic Health Agency of Canada · CAPublic Health Agency of Sweden · SEThe University of Texas Medical Branch at Galveston · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe recently developed Xpert® Ebola Assay is a novel nucleic acid amplification test for simplified detection of Ebola virus (EBOV) in whole blood and buccal swab samples. The assay targets sequences in two EBOV genes, lowering the risk for new variants to escape detection in the test. The objective of this report is to present analytical characteristics of the Xpert® Ebola Assay on whole blood samples. METHODS AND

findingsThis study evaluated the assay's analytical sensitivity, analytical specificity, inclusivity and exclusivity performance in whole blood specimens. EBOV RNA, inactivated EBOV, and infectious EBOV were used as targets. The dynamic range of the assay, the inactivation of virus, and specimen stability were also evaluated. The lower limit of detection (LoD) for the assay using inactivated virus was estimated to be 73 copies/mL (95% CI: 51-97 copies/mL). The LoD for infectious virus was estimated to be 1 plaque-forming unit/mL, and for RNA to be 232 copies/mL (95% CI 163-302 copies/mL). The assay correctly identified five different Ebola viruses, Yambuku-Mayinga, Makona-C07, Yambuku-Ecran, Gabon-Ilembe, and Kikwit-956210, and correctly excluded all non-EBOV isolates tested. The conditions used by Xpert® Ebola for inactivation of infectious virus reduced EBOV titer by ≥6 logs.

conclusionIn summary, we found the Xpert® Ebola Assay to have high analytical sensitivity and specificity for the detection of EBOV in whole blood. It offers ease of use, fast turnaround time, and remote monitoring. The test has an efficient viral inactivation protocol, fulfills inclusivity and exclusivity criteria, and has specimen stability characteristics consistent with the need for decentralized testing. The simplicity of the assay should enable testing in a wide variety of laboratory settings, including remote laboratories that are not capable of performing highly complex nucleic acid amplification tests, and during outbreaks where time to detection is critical.

Indexed as

AnimalsChlorocebus aethiopsEbolavirusGenes, ViralHemorrhagic Fever, EbolaHost-Pathogen InteractionsHumansMass ScreeningNucleic Acid Amplification TechniquesReproducibility of ResultsRNA, ViralSensitivity and SpecificityTime FactorsVero CellsVirus InactivationRNA, Viral

Identifiers

PMID26562786
PMCPMC4643052
OpenAlexW2176136214

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.