• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    Voices for Medtech: AdvaMed and MDMA Leaders Share Thoughts

    Digitize Your QMS via an Enterprise Cloud Platform

    Diagnostic Desperation: A Look at IVD Trends During COVID-19

    Resourceful Resources: Materials Make a Difference During the Pandemic

    Stressed Testing: Challenges with Medical Device Testing
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Top News
    Cretex CFO Announces Retirement

    New AI-Based Tool Developed for Coronary Artery Analysis, Intervention Planning

    First Reported Use of Pulse Biosciences' CellFX System

    EUA Granted for New COVID-19, Flu A, Flu B Combo Kit

    EchoNous Expands Its Kosmos Hardware Platform
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Voices for Medtech: AdvaMed and MDMA Leaders Share Thoughts

    Digitize Your QMS via an Enterprise Cloud Platform

    Diagnostic Desperation: A Look at IVD Trends During COVID-19

    Resourceful Resources: Materials Make a Difference During the Pandemic

    Stressed Testing: Challenges with Medical Device Testing
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Cybersecurity Compromises, Courtesy of COVID-19

    A Look at the Actual Device Costs for Hospitals

    Show Time: Here’s What a Year of No Tradeshows Meant for Small Businesses

    FDA Making Progress With Technology and Data Action Plans

    What’s Hot Now in Medtech M&A
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    Concise Engineering

    Medicoil

    Spectrum Plastics Group

    Medbio LLC

    FUTEK Advanced Sensor Technology Inc.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    How Grant Funding Works and How It Can Help

    Refurbished Medical Equipment Testing and Certification Under the NEC

    Taking the First Step with Metal Components

    4 Trends Driving Medical Manufacturing in 2021

    Pioneering AI Solutions to Reinforce Healthcare Services
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Forefront Medical Technology

    K-Tube Technologies

    MW Life Sciences

    Medicoil

    Qosina Corp.
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • Podcasts
    • Resources
    • eBook
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Breaking News

    Siemens Healthineers Obtains EUA for Semi-Quantitative Antibody Test

    The SARS-CoV-2 IgG Antibody Test offers the first EUA for a semi-quantitative assay to help clinicians assess the level of an individual‘s immune response.

    Related CONTENT
    • Varian CEO to Retire Following Siemens Healthineers Acquisition
    • South Korean HIV Testing to Reach Peak Market Value This Year
    • Refurbished Medical Imaging Equipment Market to be Worth $21.14 Billion By 2027
    • Additive Manufacturing Center of Excellence Welcomes New Advisory Board Additions
    • Siemens Healthineers’ Laboratory-Based IL-6 Assay Receives EUA
    Business Wire08.05.20
    Siemens Healthineers has received FDA Emergency Use Authorization (EUA) for the SARS-CoV-2 IgG (COV2G) antibody test.1 This is the first antibody test authorized with a semi-quantitative detection claim and the fifth antibody test from the company to receive EUA that offers sensitivity and specificity of greater than 99 percent. The COV2G antibody test offers both a positive or negative result for IgG antibodies and reports a numerical result expressed as index value. The test also attained the CE-mark and is now broadly available globally.

    A positive or negative result for IgG antibodies provides insight into an individual’s prior exposure to the SARS-CoV-2 virus. Importantly, a semi-quantitative result enables clinicians to gauge the level of IgG antibodies in a patient’s blood sample. With this numerical value, clinicians can establish a baseline and be better equipped to assess changes of an individual’s immune response to the SARS-CoV-2 virus. Comparison of numerical results will help determine how SARS-CoV-2 antibodies develop in an individual and persist over time. A semi-quantitative result is necessary to accurately establish the level of IgG that may be protective, and the Siemens Healthineers’ COV2G assay is well positioned to support this global pursuit.

    When an individual is infected with the SARS-CoV-2 virus, unique antibodies will develop at different stages of the infection. Whereas the Siemens Healthineers SARS-CoV-2 Total antibody test detects antibodies to IgM and IgG that are present both early and later during the immune response, the COV2G antibody test specifically detects IgG antibodies that persist, and are the basis for an individual’s longer term immune response. The combination of these tests provides a complete picture of a patient’s serological status for the most accurate results throughout his or her contiuum of care.

    “Our high-quality antibody test helps clinicians assess the level of a person‘s immune response, which is an important tool to have at this stage of the pandemic,” said Deepak Nath, Ph.D., president of Laboratory Diagnostics for Siemens Healthineers. “Siemens Healthineers offers a robust portfolio of reliable tests to help support patient care and fight COVID-19.”

    Highly accurate antibody test results support key decision-making for individuals and communities. Antibody tests have multiple uses:
    • As an adjunct to PCR tests to aid in clinical assessment2
    • To help determine prior exposure to the virus, by detecting antibodies that may neutralize the virus3,4
    • To potentially identify donors of convalescent plasma5
    • For epidemiological purposes including establishing prevalence of disease in populations
    • To potentially help verify effectiveness of vaccines as they become available3,4

    Antibody tests from Siemens Healthineers are well-positioned to aid vaccine development efforts. The COV2G antibody test, and all SARS-CoV-2 antibody tests from Siemens Healthineers, detect antibodies to S1RBD. Multiple potential vaccines in development for SARS-CoV-2 include the spike protein, specifically S1RBD—a key protein on the surface of the SARS-CoV-2 virus—within their focus.

    Among the considerations for accelerated vaccine approval, according to most recent FDA guidance issued on June 30, validated serology testing in clinical trials may play a pivotal role in assessing surrogate endpoints such as immune response to a vaccine. This requires additional understanding of SARS-CoV-2 immunology and, specifically, vaccine immune responses that might be reasonably likely to predict protection against COVID-19 and post-marketing studies to affirm predicted efficacy. The COV2G test meets or exceeds FDA EUA requirements.6

    The COV2G antibody test is available on an expansive installed base of analyzers installed in the U.S. and in countries that accept the CE mark worldwide. This includes the Atellica Solution and ADVIA Centaur XP and XPT families of analyzers. Comparable tests for Siemens Healthineers Dimension Vista and Dimension EXL systems also are being pursued.7

    Siemens Healthineers has distinguished itself during the pandemic as a provider of quality antibody tests. For example, in a recent head-to-head evaluation of four commercial antibody tests conducted by Public Health England, in partnership with the University of Oxford, Siemens Healthineers’ COV2T assay was the only test that met both sensitivity and specificity targets.8

    To learn more about antibody test offerings from Siemens Healthineers, visit https://www.siemens-healthineers.com/laboratory-diagnostics/assays-by-diseases-conditions/infectious-disease-assays/cov2g-assay.

    References
    1 This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for detecting the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Product availability may vary by country and is subject to varying regulatory requirements.
    2 https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antibody-tests-guidelines.html Accessed June 21, 2020
    3 Bao L, Deng W, Gao H, et al. Reinfection could not occur in SARS-CoV-2 infected rhesus macaques. Posted 2020 May 1. https://doi.org/10.1101/2020.03.13.990226
    4 Cross-neutralization of SARS-CoV-2 by a human monoclonal SARS-CoV antibody. Pinto, D. et al. Nature https://doi.org/10.1038/s41586-020-2349-y (2020).
    5 Luchsinger LL et al. Serological Analysis of New York City COVID19 Convalescent Plasma Donors. https://doi.org/10.1101/2020.06.08.20124792.This version posted June 9, 2020
    6 Positive percent agreement (sensitivity) ≥ 90%; Negative percent agreement (specificity) ≥ 95% https://www.fda.gov/media/137698/download. This version posted June 26, 2020
    7 Available under IVD CE Mark. Product availability varies by country.
    8 Evaluation of sensitivity and specificity of four commercially available SARS-CoV-2 antibody immunoassays. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/898437/Evaluation__of_sensitivity_and_specificity_of_4_commercially_available_SARS-CoV-2_antibody_immunoassays.pdf. This version posted July 2020
    Related Searches
    • Diagnostics
    Related Knowledge Center
    • Diagnostics
    Suggested For You
    Varian CEO to Retire Following Siemens Healthineers Acquisition Varian CEO to Retire Following Siemens Healthineers Acquisition
    South Korean HIV Testing to Reach Peak Market Value This Year South Korean HIV Testing to Reach Peak Market Value This Year
    Refurbished Medical Imaging Equipment Market to be Worth $21.14 Billion By 2027 Refurbished Medical Imaging Equipment Market to be Worth $21.14 Billion By 2027
    Additive Manufacturing Center of Excellence Welcomes New Advisory Board Additions Additive Manufacturing Center of Excellence Welcomes New Advisory Board Additions
    Siemens Healthineers’ Laboratory-Based IL-6 Assay Receives EUA Siemens Healthineers’ Laboratory-Based IL-6 Assay Receives EUA
    Thyroid Function Tests Market in India to Reach $125 Million in 2025 Thyroid Function Tests Market in India to Reach $125 Million in 2025
    CorVent, Siemens Healthineers Ink RESPOND-19 Ventilator Distribution Deal CorVent, Siemens Healthineers Ink RESPOND-19 Ventilator Distribution Deal
    FDA, EU Nods for POC Testing on Siemens Healthineers FDA, EU Nods for POC Testing on Siemens Healthineers' epoc NXS Host Mobile Computer
    RSNA News: Siemens Introduces Cios Flow Mobile C-arm System RSNA News: Siemens Introduces Cios Flow Mobile C-arm System
    The Lost Year: 2020 Year in Review The Lost Year: 2020 Year in Review
    The Top 30 and M&A in 2021: What’s Next? The Top 30 and M&A in 2021: What’s Next?
    Babson Diagnostics Closes $13.7 Million Series A Financing Babson Diagnostics Closes $13.7 Million Series A Financing
    BD Makes Executive Leadership Appointments BD Makes Executive Leadership Appointments
    Siemens Healthineers Collaborates with Novartis Pharma Siemens Healthineers Collaborates with Novartis Pharma
    FDA Clears Siemens Healthineers AI-Based Software FDA Clears Siemens Healthineers AI-Based Software

    Related Breaking News

    • Diagnostics
      EUA Granted for New COVID-19, Flu A, Flu B Combo Kit

      EUA Granted for New COVID-19, Flu A, Flu B Combo Kit

      One multiplex real-time PCR diagnostic kit can simultaneously detect and differentiate SARS-CoV-2, influenza A and influenza B.
      Michael Barbella, Managing Editor 03.05.21

    • Diagnostics
      EchoNous Expands Its Kosmos Hardware Platform

      EchoNous Expands Its Kosmos Hardware Platform

      Adds continuous wave and pulsed wave Doppler capabilities.
      Charles Sternberg, Assistant Editor 03.04.21

    • Chronic Disease | Diagnostics
      Bio-Techne to Acquire Asuragen for $320M

      Bio-Techne to Acquire Asuragen for $320M

      Bio-Techne gains genetic carrier screening and oncology testing kits.
      Sam Brusco, Associate Editor 03.04.21


    • Diagnostics | Digital Health
      Philips, Disney Join Forces to Reduce Childrens

      Philips, Disney Join Forces to Reduce Childrens' MRI Anxiety

      Will explore effects and use of animated stories and characters, including Disney favorites, as part of Philips Ambient Experience solution.
      Sam Brusco, Associate Editor 03.03.21

    • Diagnostics
      Quidel

      Quidel's QuickVue At-Home COVID-19 Test Earns EUA

      Easy-to-use at-home test provides results in ten minutes with a doctor’s prescription.
      Sam Brusco, Associate Editor 03.02.21

    • Diagnostics
      Hologic Buys Molecular Dx Firm Diagenode for $159M

      Hologic Buys Molecular Dx Firm Diagenode for $159M

      Diagenode brings more than 30 CE-marked, real-time PCR tests.
      Sam Brusco, Associate Editor 03.02.21


    • Diagnostics
      SpinTech Inc. Acquires MR Innovations

      SpinTech Inc. Acquires MR Innovations

      Includes an expert team of engineers and physicists and MR Innovations' patents, published papers and network of global collaborators.
      Charles Sternberg, Assistant Editor 02.24.21

    • Diagnostics
      Rice University Researchers Receive Funding to Develop Covid-19 Sensor System

      Rice University Researchers Receive Funding to Develop Covid-19 Sensor System

      Real-time electronic system will be able to detect minute amounts of SARS-CoV-2.
      Charles Sternberg, Assistant Editor 02.22.21

    • Diagnostics
      BD Collaborates with Scanwell Health

      BD Collaborates with Scanwell Health

      Aims to create an at-home rapid test for SARS-CoV-2 using a BD antigen test and the Scanwell Health mobile app.
      Charles Sternberg, Assistant Editor 02.22.21


    • Diagnostics
      Study Validates Vocalis Health’s COVID-19 Screening Tool

      Study Validates Vocalis Health’s COVID-19 Screening Tool

      VocalisCheck obtains CE mark approval for medical use.
      Charles Sternberg, Assistant Editor 02.18.21

    • Diagnostics
      Test Identifies COVID-19 Patients at Increased Risk of Intubation With Mechanical Ventilation

      Test Identifies COVID-19 Patients at Increased Risk of Intubation With Mechanical Ventilation

      The assay is currently available in Europe.
      Michael Barbella, Managing Editor 02.16.21

    • Diagnostics
      FDA Grants EUA to Bio-Rad Reliance Assay Kits

      FDA Grants EUA to Bio-Rad Reliance Assay Kits

      Help physicians more easily detect and differentiate SARS-CoV-2 in patients.
      Charles Sternberg, Assistant Editor 02.16.21


    • Diagnostics
      Suitcase Laboratory to Detect COVID-19 in Development

      Suitcase Laboratory to Detect COVID-19 in Development

      Mobile laboratory for rapid detection of SARS-CoV-2 for Africa.
      Sam Brusco, Associate Editor 02.12.21

    • Diagnostics
      BD Earns EUA, CE Mark for Combo SARS-CoV-2, Influenza A+B Test

      BD Earns EUA, CE Mark for Combo SARS-CoV-2, Influenza A+B Test

      Also shows ability to detect U.K., South African variants of COVID-19.
      Sam Brusco, Associate Editor 02.12.21

    • Diagnostics
      ProPhase Labs Begins Saliva-Based, Viral RT-PCR Multiplex-Testing

      ProPhase Labs Begins Saliva-Based, Viral RT-PCR Multiplex-Testing

      System can be used for COVID-19, Influenza A & B, and other viruses.
      Charles Sternberg, Assistant Editor 02.09.21


    Trending
    • Hardy Diagnostics Releases Rapid Test For COVID-19
    • TransEnterix Changes Name To Asensus Surgical
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • Plastikos Medical Begins Phase II Of Expansion
    • Top 10 Trends In The Medical Device And Equipment Industry
    Breaking News
    • Cretex CFO Announces Retirement
    • New AI-Based Tool Developed for Coronary Artery Analysis, Intervention Planning
    • First Reported Use of Pulse Biosciences' CellFX System
    • EUA Granted for New COVID-19, Flu A, Flu B Combo Kit
    • EchoNous Expands Its Kosmos Hardware Platform
    View Breaking News >
    CURRENT ISSUE

    March 2021

    • Stressed Testing: Challenges with Medical Device Testing
    • Resourceful Resources: Materials Make a Difference During the Pandemic
    • Diagnostic Desperation: A Look at IVD Trends During COVID-19
    • Digitize Your QMS via an Enterprise Cloud Platform
    • Voices for Medtech: AdvaMed and MDMA Leaders Share Thoughts
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Thymoquinone Inhibits Viral Infection in In Vitro Settings, New Study Finds
    IFT Transitions 2021 Annual Event to Digital Experience
    NY Federal Judge Enters Permanent Injunction Against Dietary Supplement Manufacturer
    Coatings World

    Latest Breaking News From Coatings World

    Sherwin-Williams Announces Resignation of President, COO
    Ashland Completes Expansion, Relocation of Viatel Bioresorbable Polymers Manufacturing Facility
    Evonik Receives Sustainability Award from EcoVadis
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Cretex CFO Announces Retirement
    New AI-Based Tool Developed for Coronary Artery Analysis, Intervention Planning
    First Reported Use of Pulse Biosciences' CellFX System
    Contract Pharma

    Latest Breaking News From Contract Pharma

    AGC Biologics Expands Cell and Gene Facility in Italy
    Celonic to Boost Cell & Gene Therapy Production
    Pharmaron Acquires Biomanufacturing Site in the UK from AbbVie
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Ulta Beauty Opens in Herald Square
    Elizabeth Arden Taps Sui He as Global Brand Ambassador
    Natura &Co Outperforms the Global Market in Q4 2020
    Happi

    Latest Breaking News From Happi

    What You're Reading on Happi.com
    Indie Beauty Innovators Wanted
    Cosmetic Chemists Seek Mentors
    Ink World

    Latest Breaking News From Ink World

    Massilly North America Adds Koenig & Bauer MetalStar 3 Metal Decorating Press
    Hydrocarbon Solvents Market to Surpass $8.1 Billion by 2030
    Access Direct Mail Doubles Revenue with SCREEN's Truepress Jet520HD
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Arjobex America welcomes Maggie Naberezny to sales team
    Henkel publishes 30th Sustainability Report
    Avery Dennison Smartrac launches new Circus Pro inlays
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    FPInnovations Develops Biodegradable Mask
    Sani Professional Sanitizing and Disinfecting Products Approved by EPA
    Autefa Solutions Offers Fully Automated Line for Protective Mask Production
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Colfax Decides to Divide Its Businesses
    Stryker Corp.'s 2020 Sales Slip 3.6 Percent
    Bioventus Appoints Managing Director, China and Asia Pacific
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Comercial Kywi Improves Customer Service, Front-Store Operations with Zebra Mobile Solution
    Global Smart Glass Market to Register 6.8% CAGR Between 2021-28: Grand View Research
    Global Printed Circuit Board Market Projected to Reach $69.32 Billion by 2027

    Copyright © 2021 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login