ArticleThe Journal of infectious diseases2016
Development, Evaluation, and Integration of a Quantitative Reverse-Transcription Polymerase Chain Reaction Diagnostic Test for Ebola Virus on a Molecular Diagnostics Platform.
Article in The Journal of infectious diseases, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
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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.
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Who cites it
6 citing papers in PubMed, 14 citations in OpenAlex.
- Diagnostics of Ebola virus.Frontiers in public health · 2023Review
- Simultaneous detection of Marburg virus and Ebola virus with TaqMan-based multiplex real-time PCR method.Journal of clinical laboratory analysis · 2021Article
- Where are the Ebola diagnostics from last time?Nature · 2019Article
- 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 · 2018Review
- The predictor of mortality outcome in adult patients with Ebola virus disease during the 2014-2015 outbreak in Guinea.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2017Observational
- Molecular Diagnostic Field Test for Point-of-Care Detection of Ebola Virus Directly From Blood.The Journal of infectious diseases · 2016Article
Corrections and comments
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Authors and funding
16 authors at 5 institutions in 2 countries.
Funding
Abstract
backgroundThe 2013-2016 Ebola epidemic in West Africa resulted in accelerated development of rapid diagnostic tests for emergency outbreak preparedness. We describe the development and evaluation of the Idylla™ prototype Ebola virus test, a fully automated sample-to-result molecular diagnostic test for rapid detection of Zaire ebolavirus (EBOV) and Sudan ebolavirus (SUDV).
methodsThe Idylla™ prototype Ebola virus test can simultaneously detect EBOV and SUDV in 200 µL of whole blood. The sample is directly added to a disposable cartridge containing all reagents for sample preparation, RNA extraction, and amplification by reverse-transcription polymerase chain reaction analysis. The performance was evaluated with a variety of sample types, including synthetic constructs and whole blood samples from healthy volunteers spiked with viral RNA, inactivated virus, and infectious virus.
resultsThe 95% limits of detection for EBOV and SUDV were 465 plaque-forming units (PFU)/mL (1010 copies/mL) and 324 PFU/mL (8204 copies/mL), respectively. In silico and in vitro analyses demonstrated 100% correct reactivity for EBOV and SUDV and no cross-reactivity with relevant pathogens. The diagnostic sensitivity was 97.4% (for EBOV) and 91.7% (for SUDV), the specificity was 100%, and the diagnostic accuracy was 95.9%.
conclusionsThe Idylla™ prototype Ebola virus test is a fast, safe, easy-to-use, and near-patient test that meets the performance criteria to detect EBOV in patients with suspected Ebola.
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