bioMérieux announces the CE marking of 3 dengue immunoassays on VIDAS(r)
Marcy l'Etoile, France - April, 7th 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(r) DENGUE NS1 Ag
* VIDAS(r) Anti-DENGUE IgM
* VIDAS(r) 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 (1-2).
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
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 (3-5).
VIDAS(r) 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(r) 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
Performed on the VIDAS(r) family platforms, VIDAS(r) 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(r) DENGUE panel is easy to use and accessible to all laboratories.
Capitalizing on bioMérieux's expertise in infectious diseases, VIDAS(r) DENGUE
assays enable clear-cut results with no equivocal zone and an objective
interpretation thanks to the automation.
"This new VIDAS(r) 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
Launched 30 years ago, VIDAS(r) has transformed the field of immunoassays
offering laboratories universal access to a simple, automated and robust
technology providing fast and reliable results. Today, VIDAS(r) is still the
most widely used immunoassay system in clinical laboratories worldwide.
The VIDAS(r) menu covers a wide range of pathologies, including infectious and
chronic diseases and a range of tests dedicated to emergency and critical care.
A number of these parameters are part of the bioMérieux full solution to
address the global challenges of antimicrobial resistance (AMR) and sepsis. As
it enters into its fourth decade, VIDAS(r) remains a major focus of the
bioMérieux immunoassay strategy with ongoing research into new parameters and
frequent launches that create value for labs and clinicians, for the benefits
of the patients.
A world leader in the field of in vitro diagnostics for over 55 years,
bioMérieux is present in 44 countries and serves more than 160 countries with
the support of a large network of distributors. In 2020, revenues reached
EUR3.1 billion, with over 90% of international sales.
bioMérieux provides diagnostic solutions (systems, reagents, software and
services) which determine the source of disease and contamination to improve
patient health and ensure consumer safety. Its products are mainly used for
diagnosing infectious diseases. They are also used for detecting microorganisms
in agri- food, pharmaceutical and cosmetic products.
Corporate website: www.biomerieux.com.
1. Wilder-Smith A, Ooi E-E, Horstick O, Wills B. Dengue. The Lancet.
2. WHO. Dengue and severe dengue. Fact sheets. [cited 2021 March 31]. Available
3. Raafat N, Blacksell SD, Maude RJ. A review of dengue diagnostics and
implications for surveillance and control. Trans R Soc Trop Med Hyg.
4. Muller DA, Depelsenaire AC, Young PR. Clinical and Laboratory Diagnosis of
Dengue Virus Infection. J Infect Dis. 2017;215(suppl_2):S89-S95.
5. Peeling RW, Artsob H, Pelegrino JL, Buchy P, Cardosa MJ, Devi S, et al.
Evaluation of diagnostic tests: dengue. Nat Rev Microbiol. 2010;8(12
6 WHO, CDC, HAS, PAHO dengue testing recommendations.