• 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
    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers

    Diabetes Technology Manufacturers Seemingly on a Sugar Rush

    Post-Pandemic Partnerships: A Full-Service Outsourcing Discussion

    Discovering the Value of Surface Treatments and Coatings for Medtech
    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
    Regulatory
    Financial/Business
    Top News
    Pediatric Medical Device Competition Reveals Five Finalists

    Medical Device Packaging Market to Reach $34B by 2027

    Penumbra Secures CE Mark for its Advanced Mechanical Thrombectomy Tech

    Digital Twin Tech to Significantly Impact India's Cardiology Devices Sector

    Anumana's ECG Pulmonary Hypertension AI Algorithm Gains Breakthrough Status
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers

    Diabetes Technology Manufacturers Seemingly on a Sugar Rush

    Post-Pandemic Partnerships: A Full-Service Outsourcing Discussion

    Discovering the Value of Surface Treatments and Coatings for Medtech
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Injecting Neurostimulators into Blood Vessels (We Swear, It’s Not Sci-Fi)

    Understanding the Costs of Care in the OR

    Sick of Being Sick: Pandemic Fatigue Flares at AAOS

    Managing Critical Healthcare Supply Chains in Turbulent Times

    To Drive Value, Human Capital Leaders Turn to Outsourced Solutions
    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
    Arthur G. Russell Co. Inc., The

    Fusion Biotec Inc.

    Xact Wire EDM Corp.

    Trademark Plastics Inc.

    BMP Medical
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    3D Printing in Dental Prosthodontics, Orthodontics, and Surgery

    What New Tech Can Improve Your Medical Manufacturing Plant?

    Why Medical Device Firms Must Navigate the Muddy Waters of ESG Requirements

    Medical Device Servicing vs. Remanufacturing

    Digital Marketplaces for Medical Equipment Come of Age
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Arthur G. Russell Co. Inc., The

    Fusion Biotec Inc.

    Xact Wire EDM Corp.

    Trademark Plastics Inc.

    BMP Medical
    • 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
    • eBook
    • Resources
    • Podcasts
    • 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

    FDA Publishes COVID-19 Molecular Dx Test Comparative Performance Data

    Shows Limit of Detection of over 55 authorized molecular diagnostic COVID-19 tests against a standardized sample panel.

    Related CONTENT
    • Roche to Acquire Long-Term Partner TIB Molbiol
    • Smaller Devices Require More Efficient Material Integration
    • Pandemic Underscores Importance of Medtech Material Innovation
    • Disinfectant Resistance is Crucial in Medtech Material Selection
    • Electronics Integration Impacting Medtech Materials
    U.S. Food and Drug Administration09.16.20
    The U.S. Food and Drug Administration published comparative performance data for some authorized COVID-19 molecular diagnostic tests. The tables show the Limit of Detection (LoD) of more than 55 authorized molecular diagnostic COVID-19 tests against a standardized sample panel provided by the FDA. The FDA provided these standardized samples, known as a reference panel, to test developers who are required to assess their test’s performance against this panel (or other FDA-recommended reference materials) as a condition of their Emergency Use Authorization (EUA).
     
    “By providing this panel to both commercial and laboratory test developers and evaluating the data we receive, we are able to gain valuable insight into the comparative performance of different authorized molecular diagnostic tests under the same conditions,” said Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health. “Reference panels can be used in many ways to support test development and authorization, but most importantly, they are a powerful tool in monitoring test performance and ensuring that Americans have access to diagnostics they can trust.”
     
    The FDA began distributing the reference panel of samples in May and has provided it to more than 150 developers as a resource in the development and validation of accurate and reliable diagnostic tests. In order to ensure accuracy of test results using the reference panel, the FDA did not disclose the amount of viral material in the samples, resulting in a blind test for developers.
     
    In the data published, a lower LoD represents a test’s ability to detect a smaller amount of viral material in a given sample, signaling a more sensitive test. However, the data does not indicate how sensitive a particular test is, and, therefore, cannot be used by itself to determine whether to authorize a test or other regulatory action. Instead, the data gives laboratories, healthcare providers and patients a new resource on the relative performance of available tests to better inform which tests they choose to use. The FDA will continue to update the table as it receives additional results.
    Related Searches
    • Diagnostics
    Related Knowledge Center
    • Diagnostics
    Suggested For You
    Roche to Acquire Long-Term Partner TIB Molbiol Roche to Acquire Long-Term Partner TIB Molbiol
    Smaller Devices Require More Efficient Material Integration Smaller Devices Require More Efficient Material Integration
    Pandemic Underscores Importance of Medtech Material Innovation Pandemic Underscores Importance of Medtech Material Innovation
    Disinfectant Resistance is Crucial in Medtech Material Selection Disinfectant Resistance is Crucial in Medtech Material Selection
    Electronics Integration Impacting Medtech Materials Electronics Integration Impacting Medtech Materials
    Ultra-Fast COVID-19 Antibody Test Under Development Ultra-Fast COVID-19 Antibody Test Under Development
    COVID-19 Sample Collection Kits Market to Reach $16.56B by 2028 COVID-19 Sample Collection Kits Market to Reach $16.56B by 2028
    Global Diabetes Care Devices Market to Garner $39.4B by 2027 Global Diabetes Care Devices Market to Garner $39.4B by 2027
    Maintaining Quality in the Fast-Paced Contract Manufacturing Industry Maintaining Quality in the Fast-Paced Contract Manufacturing Industry
    FDA Grants EUA to Beckman Coulter FDA Grants EUA to Beckman Coulter's COVID-19 Antibody Test
    QIAGEN Granted EUA for its 4-Plex COVID-19 Test QIAGEN Granted EUA for its 4-Plex COVID-19 Test
    FDA Policy Supports the Use of Dry Heat Systems in the Processing of N95 Masks FDA Policy Supports the Use of Dry Heat Systems in the Processing of N95 Masks
    Cardiovascular Device Market Expands to Tackle Higher Disease Burden Cardiovascular Device Market Expands to Tackle Higher Disease Burden
    Global Supply Chain Wisdom from Coronavirus-Colored Lenses Global Supply Chain Wisdom from Coronavirus-Colored Lenses
    Diagnosing the IVD Market: An Interview with TEAM Technologies Diagnosing the IVD Market: An Interview with TEAM Technologies

    Related Content

    • Diagnostics
      Roche to Acquire Long-Term Partner TIB Molbiol

      Roche to Acquire Long-Term Partner TIB Molbiol

      Expands PCR-test portfolio in the fight against new infectious diseases.
      GlobeNewswire 09.09.21

    • Materials
      Smaller Devices Require More Efficient Material Integration

      Smaller Devices Require More Efficient Material Integration

      Silicones are becoming increasingly well-suited for implantable medical devices and combination products.
      Michael Barbella, Managing Editor 08.03.21

    • Materials
      Pandemic Underscores Importance of Medtech Material Innovation

      Pandemic Underscores Importance of Medtech Material Innovation

      Materials must meet the changing needs of medtech and society in general through preventative, diagnostic and therapeutic solutions.
      Michael Barbella, Managing Editor 07.30.21


    • Materials
      Disinfectant Resistance is Crucial in Medtech Material Selection

      Disinfectant Resistance is Crucial in Medtech Material Selection

      Understanding the kinds of materials that stand up to healthcare-grade disinfectants can help ensure device longevity.
      Michael Barbella, Managing Editor 07.27.21

    • Materials
      Electronics Integration Impacting Medtech Materials

      Electronics Integration Impacting Medtech Materials

      Conductive materials are becoming a necessary part of medical devices as digital healthcare continues to evolve.
      Michael Barbella, Managing Editor 07.23.21


      Trending
      • Quality Management Evolution: What to Expect in 2022
      • Dexcom Reportedly In Talks To Acquire Insulet | Medical Product Outsourcing
      • Shrinking Medical Devices Create Sizable Challenges For Micromolders | Medical Product Outsourcing
      • 5 Ways Plastics Revolutionized The Healthcare Industry | Medical Product Outsourcing
      • Prometheus Group Sued Over Reused Catheters And Rectal Sensors | Medical Product Outsourcing
      Breaking News
      • Pediatric Medical Device Competition Reveals Five Finalists
      • Medical Device Packaging Market to Reach $34B by 2027
      • Penumbra Secures CE Mark for its Advanced Mechanical Thrombectomy Tech
      • Digital Twin Tech to Significantly Impact India's Cardiology Devices Sector
      • Anumana's ECG Pulmonary Hypertension AI Algorithm Gains Breakthrough Status
      View Breaking News >
      CURRENT ISSUE

      May 2022

      • Cybersecurity Challenges Leave Medical Device Makers Insecure
      • Contract Design for Medtech
      • Diabetes Medical Device Technology Update
      • Medtech Full-Service Outsourcing Q&A 2022

      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

      Thorne Relaunches Gut Health Test with Microbiome Wipe
      Alkemist Labs Announces Alkemist Assured Seal and Next Generation Transparency Reports
      GC Rieber Foundations Expand Philanthropic Efforts
      Coatings World

      Latest Breaking News From Coatings World

      PPG Hosts The Future of Coatings' Technology Innovation Day in Amsterdam
      Azelis Expands Presence in India with Acquisition of Chemo India and Unipharm Laboratories
      Teknos Publishes Sustainability Report
      Medical Product Outsourcing

      Latest Breaking News From Medical Product Outsourcing

      Pediatric Medical Device Competition Reveals Five Finalists
      Medical Device Packaging Market to Reach $34B by 2027
      Penumbra Secures CE Mark for its Advanced Mechanical Thrombectomy Tech
      Contract Pharma

      Latest Breaking News From Contract Pharma

      Mirum Pharmaceuticals Acquires San Diego-based Satiogen
      Catalyst Biosciences Sells Complement Portfolio to Vertex Pharmaceuticals
      Insmed Appoints Drayton Wise as Chief Commercial Officer
      Beauty Packaging

      Latest Breaking News From Beauty Packaging

      La Roche-Posay Launches Matte Moisturizer for Oily Skin
      3 Amorepacific Employees Stole $2.3 Million
      L'Oreal CEO Nicolas Hieronimus On Sustainability Initiatives
      Happi

      Latest Breaking News From Happi

      Thayers Natural Remedies Celebrates 175 Years with Social Campaign
      Former Model Shirley Powell’s Indie Beauty Brand LaJeanell Comprises Gender Inclusive Skincare and Makeup
      L’Oréal's New UVMune 400 Sun Filtering Technology Protects Skin From Ultra-Long UVA Rays
      Ink World

      Latest Breaking News From Ink World

      Flint Group Flexible Packaging Europe Implements Further Price Increase
      Nazdar Launches 205 Series Inks for Roland TrueVIS SG2 and VG2 Series Printers
      Quad Adds Landa S10P Nanographic Printing Press
      Label & Narrow Web

      Latest Breaking News From Label & Narrow Web

      AWA to host 22nd Global Release Liner Industry Conference & Exhibition
      Domino assists Grace Label with supply chain disruptions
      Rotocon wins AI Business Excellence Award
      Nonwovens Industry

      Latest Breaking News From Nonwovens Industry

      Rael Raises $35M in Series B Funding
      Schobertechnologies Offers Rotary Web-fed Converting Solutions
      Thorne Relaunches Gut Health Test with Microbiome Wipe
      Orthopedic Design & Technology

      Latest Breaking News From Orthopedic Design & Technology

      Study Confirms Knee Shapes are Highly Individualized
      Stryker Launches EasyFuse Dynamic Compression for Foot & Ankle
      Extremity Medical Rolls Out OMNI Stable Ankle Fracture System
      Printed Electronics Now

      Latest Breaking News From Printed Electronics Now

      InnovationLab Acquires Flexible Printed Battery Technology from Evonik
      Canatu Receives IATF 16949:2016 Certification
      Applied Materials Announces 2Q 2022 Results

      Copyright © 2022 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