• 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
    Pharmaceutical Focus: A Look at Combination Products

    The Printed World: Additive Manufacturing in Medtech

    The Lost Year: 2020 Year in Review

    Extrusion Evolution

    Little Big Parts: Micromolding Under the Microscope
    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
    Optimize EP Launches CaRM Cardiac Device Data Management Platform

    U.S. TAVR Market Projected to Reach Nearly $5 Billion by 2030

    FDA Clears Canon Medical's Compressed SPEEDER for 3D Exams on 1.5T MR

    Cognito Therapeutics’ Lead Product Receives FDA Breakthrough Device Designation

    Moon Surgical Expands Leadership Team
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Pharmaceutical Focus: A Look at Combination Products

    The Printed World: Additive Manufacturing in Medtech

    The Lost Year: 2020 Year in Review

    Extrusion Evolution

    Little Big Parts: Micromolding Under the Microscope
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Fixing Face Mask Form and Function

    The Heart of the Matter: Trends in Cardiology

    Virtually the Same? The Challenges of Online Conferences

    Digital Health Delivers During a Year for the Ages

    Advanced Technology for Staking and Swaging Medical Plastics
    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
    Creganna Medical, part of TE Connectivity

    Concise Engineering

    Spectrum Plastics Group

    MW Life Sciences

    FUTEK Advanced Sensor Technology Inc.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Meeting Critical Ventilator Product Requirements Amid Pandemic

    Impact of COVID-19 on the Medtech Supply Chain

    Finding the Upside to a Challenging Year

    Preparing Your Design Controls for FDA Approval

    A 'Trial and Error' Approach to Micromolded Parts
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Unicep

    Element

    Medbio LLC

    Concise Engineering

    Medicoil
    • 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

    Ortho's Second COVID-19 Antibody Test With 100 Percent Specificity Debuts

    Tests will aid in responsible back-to-work assessment, according to manufacturer.

    Ortho
    The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Test is the second antibody test from Ortho Clinical Diagnostics to receive FDA Emergency Use Authorization. Image courtesy of Ortho Clinical Diagnostics.
    Related CONTENT
    • Draper Develops Noncontact ECG Sensor
    • Fixing Face Mask Form and Function
    • Will Industry’s COVID-19 Recovery End Prematurely?
    • The Current COVID-19 Environment and Emergency Use Authorizations
    • The FDA Wants to Bring Manufacturing ‘Home’
    Ortho Clinical Diagnostics04.27.20
    Ortho Clinical Diagnostics, a global developer of in-vitro diagnostics with a history of bringing critical tests for infectious diseases to market, today introduced and announced the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization to its second COVID-19 antibody test—the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Test (COVID-19 IgG antibody test). This test is one of only a handful of antibody tests to be granted Emergency Use Authorization.  
     
    Ortho previously received FDA Emergency Use Authorization for its COVID-19 total antibody test on April 14. Of note, both tests have 100% specificity.
     
    “The observed 100 percent specificity with Ortho’s VITROS SARS-CoV-2 tests allows an extremely high level of confidence so that people will not be identified as having an immune response to the virus when in fact they do not,” said Christopher D. Hillyer, M.D., president and CEO, New York Blood Center. “Statistically, the chance of error rises dramatically even with a very small decline from 100 percent in specificity, given our understanding of the prevalence of the COVID-19 virus today.”
     
    “Ortho is proud that both of our COVID-19 total and IgG tests are achieving 100 percent specificity,” said Chris Smith, Ortho Clinical Diagnostics’ CEO. “During this health crisis, good is simply not good enough. This high level of specificity is a testament to Ortho’s strong belief that every test is a life.”
     
    Ortho’s total antibody test’s launch to market in the U.S. was announced on April 3. It detects all COVID-19 related antibodies, including IgM, which appears in the early, acute stage of infection, and helps determine the onset of a patient’s immune response by monitoring all antibodies generated through disease progression. Ortho’s newest test detects only the IgG antibody which appears in a patient’s blood in the later phase of the infection and remains elevated even after recovery.
     
    Both of Ortho’s tests help health care professionals understand if a patient has been exposed to and has developed antibodies to the COVID-19 virus.
     
    “COVID-19 is a novel virus and is being both researched and treated in real-time,” said Michael P. Busch, M.D., Ph.D., director, Vitalant Research Institute. “One of the main areas of research is identifying the time and level certain antibodies appear in the blood, which can help confirm whether a patient has been infected and whether or not they have developed antibodies. Ortho’s tests, which can detect both IgG and total antibodies, will help further our understanding of both infection and immunity to facilitate proper clinical guidance.”
     
    The tests run on Ortho’s high-throughput, fully automated analyzers including its flagship VITROS XT 7600 Integrated System, the VITROS 3600 Immunodiagnostic System, the VITROS 5600 Integrated System and will soon be available on VITROS ECi/ECiQ Immunodiagnostic Systems. VITROS Systems, already installed in more than 1,000 hospitals and reference labs in the United States, are self-contained and do not require an external water source to run, offering labs placement flexibility.
     
    “Both tests run on the widely used Ortho VITROS platform and the results will paint a vivid picture of a patient’s immune response status,” said Chockalingam Palaniappan, Ph.D., chief innovation officer, Ortho Clinical Diagnostics. “Clinicians will now have invaluable information that will allow them to make decisions about the propriety of a patient returning to work. This is critical information for first responders, health care professionals and other essential personnel working with affected populations.”
     
    Ortho plans to manufacture several million COVID-19 IgG antibody tests each month.
     
    Ortho’s COVID-19 IgG antibody tests are designed and solely intended to be performed by laboratory professionals and cannot be directly used by patients as they are not for home use. Patients should consult with their health care provider to discuss antibody testing and back-to-work options.
    Related Searches
    • ortho clinical diagnostics
    • system
    • u.s. food and drug administration
    • fda
    Suggested For You
    Draper Develops Noncontact ECG Sensor Draper Develops Noncontact ECG Sensor
    Fixing Face Mask Form and Function Fixing Face Mask Form and Function
    Will Industry’s COVID-19 Recovery End Prematurely? Will Industry’s COVID-19 Recovery End Prematurely?
    The Current COVID-19 Environment and Emergency Use Authorizations The Current COVID-19 Environment and Emergency Use Authorizations
    The FDA Wants to Bring Manufacturing ‘Home’ The FDA Wants to Bring Manufacturing ‘Home’
    RenovaCare Receives FDA Conditional IDE Approval of CellMist System and SkinGun Device RenovaCare Receives FDA Conditional IDE Approval of CellMist System and SkinGun Device
    FDA OKs SentiAR FDA OKs SentiAR's Holographic Cardiac Ablation Guidance System
    OralDNA Labs Gains EUA for Saline Oral Rinse COVID-19 RT-PCR Test OralDNA Labs Gains EUA for Saline Oral Rinse COVID-19 RT-PCR Test
    BD BD's SARS-CoV-2 Antigen Test OKed in Europe
    Saliva Tests Could Spot Silent COVID-19 Carriers Saliva Tests Could Spot Silent COVID-19 Carriers
    Cepheid Cepheid's Combo COVID-19, Flu A/B, RSV Test Earns EUA
    FDA OKs Masimo’s Rad-G Pulse Oximeter FDA OKs Masimo’s Rad-G Pulse Oximeter
    FDA Clears Scientia Vascular FDA Clears Scientia Vascular's Zoom Wire
    Hologic Granted EUA for Asymptomatic COVID-19 Testing Hologic Granted EUA for Asymptomatic COVID-19 Testing
    Philips Releases QuickClear Mechanical Thrombectomy System for Blood Clot Removal Philips Releases QuickClear Mechanical Thrombectomy System for Blood Clot Removal

    Related Breaking News

    • Optimize EP Launches CaRM Cardiac Device Data Management Platform

      Optimize EP Launches CaRM Cardiac Device Data Management Platform

      Digital tool automates workflow processes and enhances data algorithms to efficiently improve patient care.
      Accesswire 01.15.21

    • Cardiovascular
      U.S. TAVR Market Projected to Reach Nearly $5 Billion by 2030

      U.S. TAVR Market Projected to Reach Nearly $5 Billion by 2030

      The use of TAVR over open surgical techniques for replacing an aortic valve has exploded globally in recent years.
      GlobalData 01.15.21

    • FDA Clears Canon Medical

      FDA Clears Canon Medical's Compressed SPEEDER for 3D Exams on 1.5T MR

      New software version for Vantage Orian 1.5T also offers a solution to help clinicians image and quantify fatty liver disease.
      Business Wire 01.15.21


    • Neurological
      Cognito Therapeutics’ Lead Product Receives FDA Breakthrough Device Designation

      Cognito Therapeutics’ Lead Product Receives FDA Breakthrough Device Designation

      Next-generation digital therapeutic is designed for the treatment of Alzheimer’s disease.
      Business Wire 01.14.21

    • Surgical
      Moon Surgical Expands Leadership Team

      Moon Surgical Expands Leadership Team

      Adds Jeffery Alvarez, David Noonan, and Nicolas Linard.
      Moon Surgical 01.14.21

    • Royal Philips Partners with Merck on Fertility Treatments

      Royal Philips Partners with Merck on Fertility Treatments

      Partnership supports improved access to care and better outcomes in fertility treatment.
      Royal Philips 01.14.21


    • FDA Clears Fever-Detecting Vital Data Sensor in New Cardiac Monitor

      FDA Clears Fever-Detecting Vital Data Sensor in New Cardiac Monitor

      Product contains integrated sensor technologies designed to measure patient activity, heart rate, and body temperature.
      PR Newswire 01.14.21

    • Surge Period Expected for ERCP and PTC Devices Market

      Surge Period Expected for ERCP and PTC Devices Market

      But the boost will not offset revenue losses due to COVID-19.
      GlobalData 01.14.21

    • Beckman Coulter Launches High-Throughput COVID-19 Antigen Test in U.S.

      Beckman Coulter Launches High-Throughput COVID-19 Antigen Test in U.S.

      Test runs on company’s analyzers are capable of processing up to 200 samples per hour, enabling high throughput screening in 30 minutes.
      Beckman Coulter 01.14.21


    • Diagnostics
      Rapid Antigen Tests Manufacturer Acquires BIOLAB

      Rapid Antigen Tests Manufacturer Acquires BIOLAB

      Deal will create jobs and increase Innova's U.S. COVID-19 test kit manufacturing capability.
      Innova Medical Group Inc. 01.14.21

    • Neurological
      Medtronic Begins Adaptive Deep Brain Stimulation Trial for Parkinson

      Medtronic Begins Adaptive Deep Brain Stimulation Trial for Parkinson's

      First-of-its-kind study tests automated therapy that responds to brain signals in Parkinson's patients.
      PR Newswire 01.14.21

    • Diagnostics
      PerkinElmer

      PerkinElmer's SARS-CoV-2 RT-PCR Assay Earns EUA for Asymptomatic Testing

      Gold-standard testing of individuals without COVID-19 symptoms key to controlling the spread.
      Business Wire 01.14.21


    • Diagnostics
      High-Volume COVID Antigen Test Receives FDA EUA

      High-Volume COVID Antigen Test Receives FDA EUA

      Ortho’s Vitros can run up to 130 tests per hour and helps address testing backlogs, supply shortages, and delayed results.
      Ortho Clinical Diagnostics 01.13.21

    • CMS Expedites Breakthrough Device Access; Industry Applauds

      CMS Expedites Breakthrough Device Access; Industry Applauds

      New rule creates an accelerated Medicare coverage pathway for innovative products that the FDA deems ‘breakthrough.’
      MPO Staff 01.13.21

    • Patient Monitoring
      Valencell Launches Blood Pressure Monitoring Tech

      Valencell Launches Blood Pressure Monitoring Tech

      New technology can be built into a myriad of devices to provide accurate blood pressure readings.
      Valencell 01.13.21


    Trending
    • Cytotron Gains Breakthrough Status To Treat Breast, Liver, And Pancreatic Cancers
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • Medtech Matters: Talking Robotic Surgery With Zimmer Biomet
    • 5 Ways Plastics Revolutionized The Healthcare Industry
    • Moon Surgical Expands Leadership Team
    Breaking News
    • Optimize EP Launches CaRM Cardiac Device Data Management Platform
    • U.S. TAVR Market Projected to Reach Nearly $5 Billion by 2030
    • FDA Clears Canon Medical's Compressed SPEEDER for 3D Exams on 1.5T MR
    • Cognito Therapeutics’ Lead Product Receives FDA Breakthrough Device Designation
    • Moon Surgical Expands Leadership Team
    View Breaking News >
    CURRENT ISSUE

    November/December 2020

    • Pharmaceutical Focus: A Look at Combination Products
    • The Printed World: Additive Manufacturing in Medtech
    • The Lost Year: 2020 Year in Review
    • 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

    Brown Fat Associated with Reductions in Chronic Disease Risk
    NIH Study Identifies Antibacterial Properties in Taurine
    NSF Begins New Certification Program
    Coatings World

    Latest Breaking News From Coatings World

    Zeppelin Acquires MTI Mischtechnik
    Ezio Braggio Joins ChemQuest Europe
    IFS Coatings Announce Carbon Offset Program
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Optimize EP Launches CaRM Cardiac Device Data Management Platform
    U.S. TAVR Market Projected to Reach Nearly $5 Billion by 2030
    FDA Clears Canon Medical's Compressed SPEEDER for 3D Exams on 1.5T MR
    Contract Pharma

    Latest Breaking News From Contract Pharma

    KORSCH, MEDELPHARM Partner on R&D Equipment Portfolio
    Frontage Bolsters Clinical Services Capabilities
    Sanofi Unveils EUROAPI as Name of New European API Company
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Neenah to Host Packaging Webinar for Printers
    W.S. Badger is Named a ‘150 Top Impact Company’
    Mana Products, Meiyume and RPG Form The Vertical Beauty Alliance
    Happi

    Latest Breaking News From Happi

    A Surge in Interest for Supplements & Vitamins
    What You're Reading on Happi.com
    Three Form Vertical Beauty Alliance
    Ink World

    Latest Breaking News From Ink World

    dar-tech, inc. Becomes U.S. Midwestern Distributor for ZS Interpolymer
    Techkon USA, Konica Minolta Partner
    Alon Bar-Shany Appointed Chairman of Highcon Board
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Exhibitor registration opens for virtual.drupa
    FTA planning in-person Forum & INFOFLEX
    Fortis Solutions Group achieves SGP certification
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Shemesh Adds U.S. Headquarters
    TZMO USA, Special Needs Group Form Partnership
    BAHP Announces 2021 Officers, Board of Directors
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Rapid Recovery Protocol Can Lead to Increased Range of Motion After TKA
    Boston Scientific Releases WaveWriter Alpha Spinal Cord Stimulators in U.S.
    New Chief Clinical Officer on Board at IncludeHealth
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Roadsimple Modernizes Warehouse Ops with Zebra Technologies
    Toppan Announces 2050 Environmental Vision
    SOI Industry Consortium Joins SEMI as Strategic Association Partner

    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