Ebola Virus Triage Test Granted Emergency Use Authorization
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By LabMedica International staff writers Posted on 14 Jun 2016 |
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Image: The Idylla fully automated, real-time polymerase chain reaction (rt-PCR) based molecular diagnostics system (Photo courtesy of Biocartis).
The 2014 Ebola virus outbreak in West Africa was the largest outbreak since its discovery 40 years ago and with over 11,000 deaths reported and affecting multiple countries, that outbreak demonstrated a clear need for improved infectious disease surveillance and management.
Today, further preparation is needed, as specialists expect sporadic Ebola virus outbreaks to continue in the future. A molecular diagnostic test for the Ebola Zaire virus has received Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA, Silver Springs, MD, USA) and may be used to detect Ebola Zaire virus in patients with signs and symptoms of Ebola virus disease.
The Idylla Ebola Virus Triage Test (Biocartis, Mechelen, Belgium) is a real-time reverse transcription polymerase chain reaction (rRT–PCR) test intended for the qualitative detection of ribonucleic acid (RNA) from the Ebola Zaire virus that was detected in the West Africa outbreak in 2014, in Ethylenediaminetetraacetic acid (EDTA) venous whole blood from individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors. The test, which delivers results within 100 minutes on a single cartridge, runs on the Biocartis Idylla platform, a fully automated, sample-to-result, real-time RT-PCR system, which allows for rapid deployment in both developed and emerging market countries.
The Idylla Ebola Virus Triage Test sample manipulation is reduced to a single step, i.e. entering the blood sample into the Idylla cartridge, after which the cartridge becomes a hermetically closed container. This reduces the risk of exposure to the Ebola virus for healthcare workers. Furthermore, the Idylla Ebola Virus Triage Test requires only minimal training of healthcare professionals and can be transported and stored at ambient temperature conditions, which enables rapid global deployment during outbreaks. Due to the difficulty in obtaining clinical specimens positive for Ebola, the Idylla Ebola Virus Triage Test was evaluated with limited numbers of contrived specimens spiked with live Ebola Zaire virus RNA.
Rudi Pauwels, PhD, Founder and Chief Executive Officer at Biocartis, said, “The 2014 Ebola and more recently the Zika outbreak, demonstrates that in today’s global world we need rapid, highly accurate and easily deployable diagnostic systems. The Idylla Ebola Virus Triage Test is the first infectious disease outbreak test authorized by the FDA on our Idylla platform, which is perfectly suited for outbreak control through early and fast testing. The test allows healthcare professionals in the field to rapidly diagnose infection, implement control measures and as such, open doors to faster and better treatment decisions.”
Related Links:
US Food and Drug Administration
Biocartis
Today, further preparation is needed, as specialists expect sporadic Ebola virus outbreaks to continue in the future. A molecular diagnostic test for the Ebola Zaire virus has received Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA, Silver Springs, MD, USA) and may be used to detect Ebola Zaire virus in patients with signs and symptoms of Ebola virus disease.
The Idylla Ebola Virus Triage Test (Biocartis, Mechelen, Belgium) is a real-time reverse transcription polymerase chain reaction (rRT–PCR) test intended for the qualitative detection of ribonucleic acid (RNA) from the Ebola Zaire virus that was detected in the West Africa outbreak in 2014, in Ethylenediaminetetraacetic acid (EDTA) venous whole blood from individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors. The test, which delivers results within 100 minutes on a single cartridge, runs on the Biocartis Idylla platform, a fully automated, sample-to-result, real-time RT-PCR system, which allows for rapid deployment in both developed and emerging market countries.
The Idylla Ebola Virus Triage Test sample manipulation is reduced to a single step, i.e. entering the blood sample into the Idylla cartridge, after which the cartridge becomes a hermetically closed container. This reduces the risk of exposure to the Ebola virus for healthcare workers. Furthermore, the Idylla Ebola Virus Triage Test requires only minimal training of healthcare professionals and can be transported and stored at ambient temperature conditions, which enables rapid global deployment during outbreaks. Due to the difficulty in obtaining clinical specimens positive for Ebola, the Idylla Ebola Virus Triage Test was evaluated with limited numbers of contrived specimens spiked with live Ebola Zaire virus RNA.
Rudi Pauwels, PhD, Founder and Chief Executive Officer at Biocartis, said, “The 2014 Ebola and more recently the Zika outbreak, demonstrates that in today’s global world we need rapid, highly accurate and easily deployable diagnostic systems. The Idylla Ebola Virus Triage Test is the first infectious disease outbreak test authorized by the FDA on our Idylla platform, which is perfectly suited for outbreak control through early and fast testing. The test allows healthcare professionals in the field to rapidly diagnose infection, implement control measures and as such, open doors to faster and better treatment decisions.”
Related Links:
US Food and Drug Administration
Biocartis
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