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bioMérieux announces the CE marking of 3 dengue immunoassays on VIDAS®07 April, 2021
bioMérieux, a world leader in the field of in vitro diagnostics, announces the CE marking of its innovative and fully-automated assays to diagnose dengue infection:
- VIDAS® DENGUE NS1 Ag
- VIDAS® Anti-DENGUE IgM
- VIDAS® Anti-DENGUE IgG
Dengue is a viral disease transmitted to humans by certain types of mosquitoes. With 100 to 400 million people affected each year, it is the most common arthropod-borne viral infection worldwide. The global incidence of this infection has grown over 8 fold during the last 20 years, with the greatest burden observed in Asia (75%) followed by Latin America and Africa.
Dengue often presents non-specifically and with fever, thereby leading to a high risk of misdiagnosis in the absence of laboratory confirmation, especially in countries where many other infectious diseases are circulating. “Presenting in different forms, from mild to life-threatening, a dengue diagnosis and optimal patient management both rely on rapid and reliable diagnostics. In line with our goal of addressing major global health issues, it is important for us to provide these easy, automated, and high-quality tests for diagnosing dengue virus infection.” said Mark Miller, Executive Vice President, Chief Medical Officer, bioMérieux.
Diagnostic testing for dengue relies on several laboratory methods, mainly manual, which each have their own advantages and limitations. If molecular assays are not available or the patient presents later during the course of the disease, serological methods are particularly well suited.
VIDAS® DENGUE NS1 Ag, Anti-DENGUE IgM and Anti-DENGUE IgG are the new automated assays intended as an aid in the diagnosis of dengue infection.
These VIDAS® DENGUE assays can be used independently to detect the viral antigen (NS1) and antibodies (IgM and IgG) produced by the host in response to the infection. These 3 serological tests are recommended by international guidelines.
Performed on the VIDAS® family platforms, VIDAS® DENGUE assays provide reliable results with improved quality compared to the existing manual methods. The performance level responds to the medical need for an early and accurate diagnosis of dengue.
The test process is fully automated, from sample identification to the result report. Based on the single test concept and the “load & go” system, the VIDAS® DENGUE panel is easy to use and accessible to all laboratories. Capitalizing on bioMérieux’s expertise in infectious diseases, VIDAS® DENGUE assays enable clear-cut results with no equivocal zone and an objective interpretation thanks to the automation.
“This new VIDAS® DENGUE solution is cost-effective and suitable for low- and middle-income countries where VIDAS® is widely available. It broadens our immunoassay offer against vector borne-diseases that will be further extended to chikungunya” said Pierre Boulud, Chief Operating Officer, Clinical Operations, bioMérieux.