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Ortho Clinical Diagnostics expands COVID-19 test offerings

Ortho Clinical Diagnostics
19 Aug 2021
Diane Li
Assistant Editor

Industry news

Ortho Clinical Diagnostics, one of the world’s largest pure-play in vitro diagnostics companies, has announced its qualitative COVID-19 Total N antibody test received U.S. Food and Drug Administration EUA. This new antibody test is the fifth assay to receive EUA within Ortho’s COVID-19 testing solutions. The test detects the individual’s immune response or total antibodies to the COVID-19 virus and is intended to help clinicians understand if their patient had a recent or prior COVID-19 infection.

Ortho’s new qualitative VITROS® Anti-SARS-CoV-2 Total N antibody test is designed to capture the nucleocapsid protein, detect total antibodies to the COVID-19 virus, and is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2. The test offers 99.2% specificity and excellent sensitivity.1 Ortho is the first company to have an EUA for both a quantitative IgG antibody assay targeting the spike protein and a total assay targeting the nucleocapsid protein.

About Ortho’s VITROS® COVID-19 Testing Solutions

Ortho’s VITROS® COVID-19 Testing Solutions help labs meet the demands of the pandemic with reliable, high-throughput testing solutions that offer SARS-CoV-2 infection and antibody testing on Ortho's trusted VITROS® Systems.

Up to 150 antibody tests or up to 130 antigen tests can be processed each hour on Ortho’s VITROS Systems, already installed in more than 1,000 labs across all 50 states in the U.S and in over 5,400 labs across the world.

The VITROS® SARS-CoV-2 Antigen Test is a high-throughput, highly accurate test that detects acute infection of SARS-CoV-2. The VITROS® COVID-19 antibody tests include IgG and Total tests that target the S1 spike protein.

The VITROS® COVID-19 Performance Dashboard allows labs to easily view COVID-19 antibody testing data and enables more informed decisions. The web-based system provides productivity information regarding Ortho analyzers, test volumes, workload balance, sample quality metrics, and reagent efficiency.

Do you use Ortho Clinical Diagnostics products in your lab? Write a review today for your chance to win a $400 Amazon gift card>>

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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.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.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 GeneticsMolecular Genetics covers the analysis of hereditary genetic disease and chromosomal abnormalities. Genetics can be analysed using DNA, RNA, and protein microarrays, PCR, RT PCR and DNA sequencing. Genetic equipment includes genetic workstations, thermal cyclers, cooling blocks and electrophoresis products. Diagnostic kits are used for DNA / RNA extraction and purification.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.FDAThe Food and Drug Association (FDA) is an agency within the U.S. Department of Health and Human Services. Among other things, it is responsible for ensuring the safety, effectiveness and quality of drugs, vaccines and other biological products, and medical devices. In Vitro DiagnosticsIn vitro diagnostics (IVD) involve testing samples outside the body, typically in a laboratory, to diagnose diseases or conditions. IVD technologies include blood tests, molecular assays, and other bodily fluid tests, enabling accurate diagnosis and monitoring of diseases. These tests are essential for guiding treatment decisions in clinical settings. Browse our peer-reviewed product directory to find the best IVD solutions; compare products, check reviews, and get pricing directly from manufacturers.Molecular DiagnosticsMolecular diagnostics use an individual’s genetic code and gene expression to diagnose and monitor diseases. The technique is used increasingly in the field of infectious diseases and oncology, as well as areas such as coagulation, HLA typing and pharmacogenomics. Molecular diagnostics plays a pivotal role in personalized medicine.CoronavirusCoronaviruses 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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