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Siemens Healthineers to expand COVID-19 testing to include antibody test

Siemens Healthineers

The antibody test, which has a potential time to result of 14 minutes, will join the rest of the company's diagnostic portfolio

30 Apr 2020
Diane Li
Assistant Editor

Industry news

Siemens Healthineers has announced it is significantly expanding its infectious disease testing capabilities to aid in the COVID-19 pandemic. Recognizing the critical need for accurate diagnostic testing to manage COVID-19, the company has developed a laboratory-based total antibody test to detect the presence of SARS-CoV-2 antibodies in blood. This total antibody test will provide a clear view of patients’ disease progression by identifying Individuals infected with the virus who have developed an immune response to the virus, even if they were asymptomatic or never diagnosed with the disease. The test, which detects both IgM and IgG antibodies, has demonstrated specificity and sensitivity of greater than 99 percent.

Siemens Healthineers anticipates availability of the total antibody test by late May 2020. Planned expanded production in the company’s Walpole, Massachusetts manufacturing facility will accommodate more than 25 million tests per month in June and beyond. The company is pursuing Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) as well as the CE Mark.

The test will be available on the Atellica Solution immunoassay analyzer, which can run up to 440 tests per hour and will enable a result in just 14 minutes. In addition, the serology test also is expected to be available on the company’s expansive installed base of ADVIA Centaur XP and XPT analyzers, which deliver up to 240 tests per hour, with a result in 18 minutes. Availability of this test on these industry leading platforms ensures more patients are tested in a shorter time.

“Siemens Healthineers is working diligently to address the need for high-quality tests in the fight against COVID-19. This test is being designed with the precision and controls, sensitivity and specificity that laboratories have come to expect from our immunoassay tests,” said Deepak Nath, PhD, President, Laboratory Diagnostics, Siemens Healthineers. “I am especially proud of the dedication of our colleagues involved in development of this test—many of whom are based at the U.S. epicenter of the pandemic.”

The test will join a robust diagnostics portfolio from Siemens Healthineers currently aiding in the prognosis, treatment and follow up of COVID-19 patients. For example, the molecular Fast Track Diagnostics (FTD) SARS-CoV-2 test kit is used to aid in the diagnosis of infection by the SARS-CoV-2 virus that causes the COVID-19 disease. Additionally, the company’s imaging, blood gas, and broad and differentiated menu of tests, including D-Dimer, provide actionable results that aid in the care of acute infected patients.

Comparable tests for Siemens Healthineers Dimension Vista and Dimension EXL systems are being pursued in the coming weeks with a view to further expand clinical reach. In addition, the company intends to develop an IgG test to provide flexibility for testing needs as the pandemic evolves.

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Immunologists use equipment such as flow Cytometers, plate readers, plate washers and fluorescent microscopes.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.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.VirusesViruses are microscopic pathogens that require a host cell to replicate. Understanding their structure, replication cycle, and impact on the immune system is crucial in developing effective treatments, vaccines, and diagnostic methods. Research continues to focus on emerging viral diseases and antiviral drug discovery. Explore solutions for virus research, detection, and treatment in our peer-reviewed product directory; compare products, check customer 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.Vaccine DevelopmentVaccine development focuses on creating immunizations to protect against infectious diseases. The process involves identifying antigens, developing and testing vaccine efficacy, and ensuring safety through preclinical testing and multiple clinical trial phases. Scientists use various approaches, including weakened or inactivated viruses, protein subunits, or mRNA. Advanced platforms and rapid diagnostic tools aid in vaccine research and testing. Explore vaccine development solutions in our peer-reviewed product directory; compare products, read reviews, and get pricing directly from manufacturers. CoronavirusCoronaviruses are a large family of viruses that can cause illnesses ranging from the common cold to more severe diseases like COVID-19. 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