ReEBOV Antigen Rapid Test kit for point-of-care and laboratory-based testing for Ebola virus disease: a field validation study

Broadhurst, M. Jana; Kelly, John D.; Miller, Ann C.; Semper, Amanda; Bailey, Daniel; Groppelli, Elisabetta; Simpson, Andrew J. H.; Brooks, Timothy; Hula, Susan; Nyoni, Wilfred; Sankoh, Alhaji B.; Kanu, Santigi; Jalloh, Alhaji; Ton, Quy; Sarchet, Nicholas; George, Peter; Perkins, Mark D.; Wonderly, Betsy; Murray, Megan; Pollock, Nira R.

doi:10.1016/s0140-6736(15)61042-x

Cited by 190 publications

(142 citation statements)

References 3 publications

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“…However, we observed that EBOV concentrations of 3.4 × 10 5 genomes/mL were present in experimentally infected nonhuman primates prior to the development of hallmark signs. In agreement with nonhuman primate testing, subsequent clinical testing demonstrated that the ReEBOV RDTs range of 1.0 × 10 5 -1.0 × 10 9 genomes/mL correlated well with threshold cycle times observed in patients with EVD during the course of acute EVD [25,27,28]. The ReEBOV RDT analytical validation presented here for FDA and WHO applications demonstrated the capacity to accurately detect EVD and provide a rapid, point-of-care test for EVD case triage and management.…”

Section: Discussionsupporting

confidence: 69%

“…The ReEBOV RDT specificity estimate ranged from 80.3% with replicate serum testing to as high as 97.5% for screening samples obtained by finger stick. This range in sensitivity has been independently observed in subsequent clinical studies [25,26]. By use of experimental nonhuman primate infections to correlate disease presentation kinetics with ReEBOV RDT performance, the detection range of the ReEBOV RDT becomes clearer.…”

Section: Discussionmentioning

confidence: 71%

“…The ReEBOV RDT analytical validation presented here for FDA and WHO applications demonstrated the capacity to accurately detect EVD and provide a rapid, point-of-care test for EVD case triage and management. Field trials and independent clinical studies further confirmed its potential clinical effectiveness (Boisen et al, unpublished data) [25,26]. The ReEBOV RDT is the first point of care RDT to receive both FDA and WHO emergency use status for the ongoing 2013-2016 West African Ebola outbreak.…”

Section: Discussionmentioning

confidence: 94%

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Analytical Validation of the ReEBOV Antigen Rapid Test for Point-of-Care Diagnosis of Ebola Virus Infection

et al. 2016

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Background. Ebola virus disease (EVD) is a severe viral illness caused by Ebola virus (EBOV). The 2013-2016 EVD outbreak inWest Africa is the largest recorded, with >11 000 deaths. Development of the ReEBOV Antigen Rapid Test (ReEBOV RDT) was expedited to provide a point-of-care test for suspected EVD cases.Methods. Recombinant EBOV viral protein 40 antigen was used to derive polyclonal antibodies for RDT and enzyme-linked immunosorbent assay development. ReEBOV RDT limits of detection (LOD), specificity, and interference were analytically validated on the basis of Food and Drug Administration (FDA) guidance.Results. The ReEBOV RDT specificity estimate was 95% for donor serum panels and 97% for donor whole-blood specimens. The RDT demonstrated sensitivity to 3 species of Ebolavirus (Zaire ebolavirus, Sudan ebolavirus, and Bundibugyo ebolavirus) associated with human disease, with no cross-reactivity by pathogens associated with non-EBOV febrile illness, including malaria parasites. Interference testing exhibited no reactivity by medications in common use. The LOD for antigen was 4.7 ng/test in serum and 9.4 ng/test in whole blood. Quantitative reverse transcription-polymerase chain reaction testing of nonhuman primate samples determined the range to be equivalent to 3.0 × 10 5 -9.0 × 10 8 genomes/mL.Conclusions. The analytical validation presented here contributed to the ReEBOV RDT being the first antigen-based assay to receive FDA and World Health Organization emergency use authorization for this EVD outbreak, in February 2015.

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Section: Discussionsupporting

confidence: 69%

Section: Discussionmentioning

confidence: 71%

Section: Discussionmentioning

confidence: 94%

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Analytical Validation of the ReEBOV Antigen Rapid Test for Point-of-Care Diagnosis of Ebola Virus Infection

et al. 2016

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“…We strongly recommend acceleration of the development of a rapid point-of-care Ebola test that would allow Ebola testing to be executed simultaneously with malaria tests, 19,20 and to be made readily available at an affordable cost. This has the potential to enhance rational screening for fever, referral of confirmed Ebola cases and uptake of malaria treatment.…”

Section: Discussionmentioning

confidence: 99%

Management of malaria in children with fever in rural Sierra Leone in relation to the 2014–2015 Ebola outbreak

Moses¹,

Tamang²,

Denisiuk

et al. 2017

public health action

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“…To date, many diagnostic tests such as GeneXpert [8], Idylla [9], real-time reverse transcription-polymerase chain reaction (RT-PCR) assays [10], and immunoassays [11], have been developed for the detection of EBOV, but most of these assays are meant to be used by trained laboratory personnel and require additional infrastructure, such as cold storage of regents, laboratory equipment, and lengthy sample-preparation steps [12]. While these diagnostic tests are easy to run in countries that have a good healthcare system, they are problematic in many parts of the world, because of limited laboratory capacity and logistical infrastructure [13].…”

mentioning

confidence: 99%

Molecular Diagnostic Field Test for Point-of-Care Detection of Ebola Virus Directly From Blood

et al. 2016

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A molecular diagnostic method for robust detection of Ebola virus (EBOV) at the point of care (POC) directly from blood samples is described. This assay is based on reverse transcriptase loop-mediated isothermal amplification (RT-LAMP) of the glycoprotein gene of EBOV. Complete reaction formulations were lyophilized in 0.2-mL polymerase chain reaction tubes. RT-LAMP reactions were performed on a battery-operated isothermal instrument. Limit of detection of this RT-LAMP assay was 2.8 × 10 2 plaque-forming units (PFU)/test and 1 × 10 3 PFU/test within 40 minutes for EBOV-Kikwit and EBOV-Makona, respectively. This assay was found to be specific for the detection of EBOV, as no nonspecific amplification was detected in blood samples spiked with closely related viruses and other pathogens. These results showed that this diagnostic test can be used at the point of care for rapid and specific detection of EBOV directly from blood with high sensitivity within 40 minutes.

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ReEBOV Antigen Rapid Test kit for point-of-care and laboratory-based testing for Ebola virus disease: a field validation study

Cited by 190 publications

References 3 publications

Analytical Validation of the ReEBOV Antigen Rapid Test for Point-of-Care Diagnosis of Ebola Virus Infection

Analytical Validation of the ReEBOV Antigen Rapid Test for Point-of-Care Diagnosis of Ebola Virus Infection

Management of malaria in children with fever in rural Sierra Leone in relation to the 2014–2015 Ebola outbreak

Molecular Diagnostic Field Test for Point-of-Care Detection of Ebola Virus Directly From Blood

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