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Gold Standard Diagnostics releases three COVID-19 antibody tests

Gold Standard Diagnostics

The IgA, IgG, and IgM assays are formatted for optimal functionality in diagnostic laboratories

19 Apr 2020
Diane Li
Assistant Editor

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The Gold Standard Diagnostics Group (GSD) including Gold Standard Diagnostics Inc., VIROTECH Diagnostics GmbH, and NovaTec Immundiagnostica GmbH has announced the immediate availability of three different serological assays for detection of antibodies against the novel coronavirus SARS-CoV-2. GSD followed the FDA’s Emergency Use Notification process as provided in the FDA’s Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency (March 16, 2020). These kits are now available worldwide.

The IgA, IgG, and IgM assays are formatted for optimal functionality in diagnostic laboratories each with a total incubation time of 90 minutes at room temperature with ready to use controls. The kits are designed to be run manually and on any open automated EIA platform. Several hundred samples were run in development studies including PCR confirmed patients, cross-reactive samples, and convalescent sample draws.

According to experts, there is a large range of applications for serologic testing. As knowledge develops about the immunity to potential reinfection of patients having previously contracted COVID-19 and recovered, antibodies testing may provide information about statistically reduced contagion risks of and from these persons. Therefore, reliable detection of these antibodies will play an important role in combating the disease and preventing the spread of infections. GSD’s COVID-19 serology assays are designed to help patients and doctors and will be a valuable tool for epidemiological studies.

Working with talented scientists who always put the patient first, and never compromise on quality has allowed Gold Standard Diagnostics to fast track high quality antibody assays to support global COVID-19 testing efforts. The ability to support antibody testing should increase our understanding of the disease and support health authorities in protecting the health of the population.

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GSD Thunderbolt ™

Gold Standard Diagnostics

An Automation Solution for Every Lab This 2-plate fully automated open platform is compact, efficient and innovative. Features include positive identification sample racks, continuous barcode reading, and on-board optics for remote trouble-shooting access. The interface is bi directional and compatible with any LIS system. User friendly, flexible, and customizable software make automation possible for any EIA application. Up to 192 results can be generated in one run on a combination of up to 8 assays. Unique Features Intelligent Racks (IR) automatically detect the position in which barcoded vials are placed 192 patient sample positions Standard 13 x 75 mm racks; custom racks for any sized vials available 14 position reagent rack holds 22 to 35mm vials Retractable carrier for loading and unloading samples & reagents Internal camera for real time viewing of probe activity Open system to process any EIA assay program  

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AntibodiesAntibodies are used in techniques such as confocal and fluorescence microscopy, flow cytometry, ELISA, ELISPOT, immunohistochemistry, western blotting and immunopreciptation. Select specific antigen reactivity, high specific affinity, low non-specific binding, monoclonal or polyclonal, primary or secondary antibodies and associated conjugates such as an enzyme or dye for visualization.Data AnalysisData analysis hardware and software is available to make data processing straight-forward yet powerful. Data software can be used for math and stats, technical graphing and image analysis. In addition, software is available for specific data analysis of electrophoresis, densitometry, ELISA and DNA sequencing.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.Cellular PathologyCellular Pathology deals with the microscopic analysis of tissue samples and cells. Sample preparation and processing includes fixation, staining, sectioning and slide mounting, using equipment such microtomes and cryostats. In choosing immunohistochemistry and immunocytochemistry kits, consider chromogens, staining method, antibodies, microscopes and imaging.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.Biopharmaceutical AdvancesBiopharmaceutical advances follow the development of pharmaceuticals derived from biotechnology, also known as biotechnology medicines. Biopharmaceuticals may be produced from cell lines, plants, or microbial cells. Important considerations of biopharmaceutical use include application, cost, production process and purification.Clinical ChemistryBiochemistry (or clinical chemistry) involves the analysis of bodily fluids using chemical tests. Techniques used include HPLC, chromatography, spectroscopy, mass spectrometry, immunochemical, electrophoresis, turbidometric / spectrophotometric assay, MRI and ISE analysis. Tests are often carried out on plasma or serum but urine (urinalysis) and fecal specimens are also processed.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.BiopharmaceuticalsBiopharmaceuticals are proteins and other compounds (such as nucleic acids) produced by living organisms that have uses as therapeutics or for in vivo diagnostics. The most well known example of a biopharmaceutical product, and the first to be approved for therapeutic use, was recombinant human insulin.Therapeutic AntibodiesTherapeutic antibodies are antibodies engineered for use in treating diseases. They can be designed to target specific antigens, blocking harmful interactions or modulating immune responses. Therapeutic antibodies are critical in treating conditions like cancer, autoimmune disorders, and infectious diseases. Explore the best therapeutic antibody products in our peer-reviewed product directory; compare options, check reviews, and get pricing directly from manufacturers.AntibodiesCoronavirusCoronaviruses are a large family of viruses that can cause illnesses ranging from the common cold to more severe diseases like COVID-19. Research into the biology, transmission, and treatment of coronaviruses has become a global priority, particularly since the emergence of SARS-CoV-2. Understanding the virus�s structure and behavior is essential for developing vaccines, diagnostics, and antiviral treatments. Explore our peer-reviewed product directory to discover the latest research tools, diagnostic tests, vaccines, and treatments for coronavirus, compare products, read reviews, and receive pricing directly from manufacturers.Covid-19COVID-19, caused by the SARS-CoV-2 virus, has led to a global health crisis with profound impacts on societies and economies. Research into diagnostics, vaccines, treatments, and understanding viral mechanisms continues to evolve. The pandemic has accelerated innovations in healthcare and biopharmaceuticals, including novel vaccine platforms and rapid testing technologies. Browse our peer-reviewed product directory to find top COVID-19 testing kits, research tools, vaccines, and treatments, compare products, read reviews, and receive direct pricing from manufacturers.

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Gold Standard Diagnostics releases three COVID-19 antibody tests