SelectScience
Join Free
Accelerating Science
NewsLife Sciences

Siemens Healthcare Diagnostics Inc. Receives Emergency Use Authorization from FDA for its VERSANT<sup>®</sup> Zika RNA 1.0 Assay (kPCR) Kit

Siemens Healthineers
2 Aug 2016
Alex Waite
Editorial Assistant

Product news

The U.S. Food and Drug Administration (FDA) has granted Siemens Healthcare Diagnostics Inc. (Siemens) an Emergency Use Authorization (EUA) for its real-time PCR Zika Virus assay, the VERSANT® Zika RNA 1.0 Assay (kPCR) Kit.

With respect to Zika in vitro diagnostic tests, FDA has been authorized to issue EUAs to allow for use of unapproved medical products or unapproved uses of approved medical products when, among other circumstances, there are no adequate, approved, and available alternatives and certain additional criteria are met.

“The FDA’s emergency use authorization of the VERSANT® Zika RNA 1.0 Assay (kPCR) Kit from Siemens can lead us one step closer to stopping the spread of the Zika virus,” says Fernando Beils, Vice President, Head of Molecular Diagnostics, Siemens. “Being able to quickly diagnose patients will help physicians to more efficiently manage those affected.”

The VERSANT® Zika RNA 1.0 Assay (kPCR) Kit is capable of detecting the presence of Zika virus, which can be an earlier indicator of Zika virus infection than anti-Zika antibodies. The molecular test is validated for plasma, serum, and urine (collected alongside a patient-matched serum or plasma specimen) from individuals meeting CDC Zika virus clinical criteria and/or CDC Zika virus epidemiological criteria, and is designed to run on the Siemens VERSANT® kPCR Sample Prep automated platform, along with several commercially available thermal cyclers.

The assay must be run by laboratories in the United States that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories. The VERSANT® Zika RNA 1.0 Assay (kPCR) Kit has not been FDA cleared or approved and is only authorized for use for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection.

Links

Siemens HealthineersCompany website

Tags

MicrobiologyMicrobiology is the study of microorganisms including protists, prokaryotes, fungi, and, often, viruses. Microorganisms are a useful research tool as genetic vectors and, in immunology, for antibiotic susceptibility testing, cellular biology and genetics. Microorganisms commonly grow readily in incubators with microbial culture media; this can contain chromogenic supplements to differentiate between cell lines. Estimate your culture’s density of microorganisms with colony counters, or screen and select colonies for desirable clones with automated colony pickers. Additionally, equipment is available to monitor environments for the presence of microbes and identify with microbial identification instruments. Find the best microbiology products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.ImmunologyImmunological techniques measure and characterize immune responses. Immunology kits and analysis systems often use techniques such as ELISA, radioimmunoassay (RIA) and immunodiffusion assays, Immunohistochemistry, and flow cytometry. Immunologists use equipment such as flow Cytometers, plate readers, plate washers and fluorescent microscopes.Cell-Based AssaysCell-based assays are used to monitor the presence, quantity and activities of a desired cellular analyte including drug molecules or biomarkers. This can reveal information on cell health (apoptosis, cytotoxicity, viability and proliferation assays), cell metabolism, cell migration and cell signaling mechanisms. Find the best cell-based assay products, kits and equipment with our peer reviewed product directory: compare products, check customer reviews and receiving pricing direct from manufacturers.Clinical MicrobiologyMicrobiology is the study of microorganisms including protists, prokaryotes, fungi, and, often, viruses. Microorganisms are a useful research tool as genetic vectors and, in immunology, for antibiotic susceptibility testing, cellular biology and genetics. Microorganisms commonly grow readily in incubators with microbial culture media; this can contain chromogenic supplements to differentiate between cell lines. Estimate your culture’s density of microorganisms with colony counters, or screen and select colonies for desirable clones with automated colony pickers. Additionally, equipment is available to monitor environments for the presence of microbes and identify with microbial identification instruments. Find the best microbiology products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.RegulatoryPharmaceutical regulations impact on all areas of drug development, manufacture and control and supply. Services are provided from the early stages of drug development and clinical trials through to dossier submission, approval and marketing. Regulatory also includes submission of analytical studies from the pharmaceutical product and safety. ImmunoassayImmunoassays are laboratory tests that utilize antibody-antigen interactions to detect specific substances. They are widely used in diagnostics for detecting diseases, drug testing, and environmental monitoring. These assays offer rapid, sensitive, and precise detection of biomarkers, making them invaluable in clinical and research labs. Browse our peer-reviewed product directory to compare immunoassay systems, read user reviews, and get pricing directly from manufacturers.Assay DevelopmentThe process of proving an assay to be sensitive with respect to the target is known as assay development. The assay should be able to characterize novel compounds and measure the potency of these compounds against a validated biological target.OlympicsZikaInfectious DiseasesInfectious diseases are caused by pathogens such as bacteria, viruses, and fungi. Effective detection, prevention, and treatment are crucial to control outbreaks and improve public health. Diagnostic tools, vaccines, and antimicrobial treatments are essential components of managing these diseases. Research into emerging pathogens and resistance patterns continues to evolve. Browse our peer-reviewed product directory to find the best diagnostic tools, prevention solutions, and treatment options; compare products, read customer reviews, and get pricing directly from manufacturers.

Related articles

Siemens Healthcare Diagnostics Inc. Receives Emergency Use Authorization from FDA for its VERSANT<sup>®</sup> Zika RNA 1.0 Assay (kPCR) Kit