Clinical evaluation of the BioFire FilmArray ® BioThreat-E test for the diagnosis of Ebola Virus Disease in Guinea

Gay-Andrieu, Françoise; Magassouba, N’Fally; Picot, Valentina; Phillips, Cynthia L.; Peyrefitte, Christophe N.; Dacosta, Brigitte; Doré, Ahmadou; Kourouma, Fodé; Ligeon-Ligeonnet, Véronique; Gauby, Corentin; Longuet, Christophe; Scullion, Matt; Faye, Ousmane; Machuron, Jean Louis; Miller, Mark A.

doi:10.1016/j.jcv.2017.04.015

Cited by 25 publications

(12 citation statements)

References 18 publications

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“…FilmArray BioThreat-E is another product that was given emergency use authorization from both the food and drug administration (FDA) and WHO. The assay is also a cartridge-based automatic RT-PCR system with a turnaround time of only 1 h [ 101 ].…”

Section: Quo Vadis Portable Viral Detection?mentioning

confidence: 99%

The vision of point-of-care PCR tests for the COVID-19 pandemic and beyond

Zhu

Zhang

et al. 2020

TrAC Trends in Analytical Chemistry

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Infectious diseases, such as the most recent case of coronavirus disease 2019, have brought the prospect of point-of-care (POC) diagnostic tests into the spotlight. A rapid, accurate, low-cost, and easy-to-use test in the field could stop epidemics before they develop into full-blown pandemics. Unfortunately, despite all the advances, it still does not exist. Here, we critically review the limited number of prototypes demonstrated to date that is based on a polymerase chain reaction (PCR) and has come close to fulfill this vision. We summarize the requirements for the POC-PCR tests and then go on to discuss the PCR product-detection methods, the integration of their functional components, the potential applications, and other practical issues related to the implementation of lab-on-a-chip technologies. We conclude our review with a discussion of the latest findings on nucleic acid-based diagnosis.

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Section: Quo Vadis Portable Viral Detection?mentioning

confidence: 99%

The vision of point-of-care PCR tests for the COVID-19 pandemic and beyond

Zhu

Zhang

et al. 2020

TrAC Trends in Analytical Chemistry

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“…17 , 38 , 40 There is potential for available laboratory kits to be re-engineered for NPT/POC testing, including kits for viral haemorrhagic pathogens 41 , 42 , 43 , 44 , arboviral diseases, 45 , 46 , 47 , 48 respiratory pathogens 49 , 50 , 51 and biothreat pathogens (including Disease X). 39 , 52 , 53 …”

Section: Molecular Diagnostics For Epidemic Preparednessmentioning

confidence: 99%

An open-source molecular diagnostic platform approach for outbreak and epidemic preparedness

Emperador

Mazzola²,

Kelly-Cirino

2020

Afr. J. Lab. Med.

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Background: Diagnostic development for outbreak pathogens has typically followed a disease-specific reactive rather than proactive response. Given the diversity of outbreak pathogens, particularly those prioritised by the World Health Organization Research and Development Blueprint, a more flexible and proactive approach to epidemic preparedness is needed to expand access to critical molecular diagnostic tests in peripheral and resource-constrained deployment settings.Objective: New and more sustainable directives are needed to spur the development of high-quality products, particularly for epidemics more often found in low- and middle-income countries. To leverage and de-risk the development process, we present the benefits and challenges of an open-source business model for co-development of molecular diagnostic tests for decentralised settings.Methods: We identify key outbreak pathogens that are available only for testing in high infrastructure laboratories and compare in-country installed base platforms that could be leveraged for menu expansion. Key strengths and challenges for development are highlighted for both platform and assay developers, with discussion of how to leverage and de-risk the process through an open-source development model.Results: Depending on the specific partner strengths, options for partnership roles are presented. The proposed open-source business model addresses the particular challenges in the detection of outbreak- and epidemic-prone pathogens in low- and middle-income countries, reduces development and deployment risks to support outbreak response, strengthens diagnostic capacity and creates a viable market for product developers.Conclusion: We hope this model for a collaborative and open-source approach for molecular diagnostics serves to encourage stakeholders to consider co-development partnerships to improve outbreak preparedness and epidemic/pandemic response.

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“…For example, this technique has been used to subtype influenza A and B viruses [50]. Other diagnostic devices such as the BioFire FilmArray can run multiple PCRs at once on a single device allowing the user to select between different panels [51][52][53][54][55]. Whether singleplex or multiplex, PCR remains the most rapid and sensitive method for the detection of viral genomes directly from clinical matrices.…”

Section: Diagnostics and Therapeutic Responsementioning

confidence: 99%