• 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
    Seeking a Revolution in Clinical Care Through AI

    Diversifying Supply Chains: New Opportunities Post Pandemic and After Brexit

    Addition by Subtraction: The Latest of Machining for Medtech

    Innovation Incubators: An R&D Roundtable

    Virtual Allies: Electronics Manufacturing Services Providers Offer Real Solutions
    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
    January AI Raises $8.8 Million in New Funding

    FDA Clears Ava Fertility Tracking Wearable Device

    First Patient in Europe Treated With Diamondback 360 Coronary Orbital Atherectomy System

    Artificial Intelligence, Machine Learning Adoption in Healthcare to Grow Considerably

    Japan to Lead APAC Assisted Reproductive Technology Devices Market
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Seeking a Revolution in Clinical Care Through AI

    Diversifying Supply Chains: New Opportunities Post Pandemic and After Brexit

    Addition by Subtraction: The Latest of Machining for Medtech

    Innovation Incubators: An R&D Roundtable

    Virtual Allies: Electronics Manufacturing Services Providers Offer Real Solutions
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Rethink Your Medtech ASC Strategy, Part 1

    Pandemic-Level Playing Field: How COVID-19 Made Space for Progress

    Tips for Reigniting Your MDR/IVDR Preparation

    Three Major Innovation Opportunities for Biomedical Textiles

    Use Vertical Integration to Increase Productivity, Drive Innovation
    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
    PTI Engineered Plastics Inc.

    Unicep

    Medbio LLC

    K-Tube Technologies

    maxon
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    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

    The 8 Major Types of PPE Supply Chain Fraud
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Creganna Medical, part of TE Connectivity

    K-Tube Technologies

    Forefront Medical Technology

    MW Life Sciences

    Unicep
    • 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

    FDA Authorizes First OTC Fully At-Home Diagnostic COVID-19 Test

    The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test.

    Related CONTENT
    • Refurbished Medical Equipment Testing and Certification Under the NEC
    • Rice University Researchers Receive Funding to Develop Covid-19 Sensor System
    • BD Collaborates with Scanwell Health
    • South Korean HIV Testing to Reach Peak Market Value This Year
    • Study Validates Vocalis Health’s COVID-19 Screening Tool
    U.S. Food and Drug Administration12.16.20
    The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with reactive molecules. The test detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample from any individual 2 years of age or older. 
     
    “Today’s authorization is a major milestone in diagnostic testing for COVID-19. By authorizing a test for over- the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes,” said FDA Commissioner Stephen M. Hahn, M.D. “As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes.” 
     
    The announcement today of the first fully at-home OTC COVID-19 diagnostic test follows last month’s authorization of the first prescription COVID-19 test for home use and last week’s announcement of the first non-prescription test system, in which a lab processes the self-collected sample. The FDA has authorized more than 225 diagnostic tests for COVID-19 since the start of the pandemic, including more than 25 tests that allow for home collection of samples, which are then sent to a lab for testing. The Ellume COVID-19 Home Test is the first COVID-19 test that can be used completely at home without a prescription. 
     
    “The FDA strongly supports innovation in test development and we have worked tirelessly with test developers to support the shared goal of getting more accurate and reliable tests to Americans who need them. Today is a promising step forward and we are eager to continue advancing additional innovation in COVID-19 testing that the science supports,” said Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health. “This test, like other antigen tests, is less sensitive and less specific than typical molecular tests run in a lab. However, the fact that it can be used completely at home and return results quickly means that it can play an important role in response to the pandemic.” 
     
    Similar to other antigen tests, a small percentage of positive and negative results from this test may be false. Therefore, for patients without symptoms, positive results should be treated as presumptively positive until confirmed by another test as soon as possible. This is especially true if there are fewer infections in a particular community, as false positive results can be more common when antigen tests are used in populations where there is little COVID-19 (low prevalence).
     
    The FDA reminds patients that all tests can experience false negative and false positive results. Individuals with positive results should self-isolate and seek additional care from their health care provider. Individuals who test negative and experience COVID-like symptoms should follow up with their health care provider as negative results do not preclude an individual from SARS-CoV-2 infection.
     
    The Ellume COVID-19 Home Test uses a mid-turbinate nasal swab (sample is collected further back than the usual nasal swab, but not as far back as nasopharyngeal swabs, which are only appropriate for use by a trained health care provider) to detect certain proteins of the virus known as antigens. The Ellume COVID-19 Home Test correctly identified 96 percent of positive samples and 100 percent of negative samples in individuals with symptoms. In people without symptoms, the test correctly identified 91 percent of positive samples and 96 percent of negative samples. The Ellume COVID-19 Home Test uses an analyzer that connects with a software application on a smartphone to help users perform the test and interpret results. Results are delivered in as little as 20 minutes to individuals via their smartphone. The mobile application requires individuals to input their zip code and date of birth, with optional fields including name and e-mail address, and reports the results as appropriate to public health authorities to monitor disease prevalence. Ellume expects to produce more than three million tests in January 2021.
     
    The FDA continues to work with test developers to expand access to COVID-19 testing and supports further development of COVID-19 tests that can be used completely at home.
    Related Searches
    • Diagnostics
    Related Knowledge Center
    • Diagnostics
    Suggested For You
    Refurbished Medical Equipment Testing and Certification Under the NEC Refurbished Medical Equipment Testing and Certification Under the NEC
    Rice University Researchers Receive Funding to Develop Covid-19 Sensor System Rice University Researchers Receive Funding to Develop Covid-19 Sensor System
    BD Collaborates with Scanwell Health BD Collaborates with Scanwell Health
    South Korean HIV Testing to Reach Peak Market Value This Year South Korean HIV Testing to Reach Peak Market Value This Year
    Study Validates Vocalis Health’s COVID-19 Screening Tool Study Validates Vocalis Health’s COVID-19 Screening Tool
    Quidel Opens New Manufacturing Facility to Boost COVID-19 Antigen Test Production Quidel Opens New Manufacturing Facility to Boost COVID-19 Antigen Test Production
    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
    Suitcase Laboratory to Detect COVID-19 in Development Suitcase Laboratory to Detect COVID-19 in Development
    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
    ProPhase Labs Begins Saliva-Based, Viral RT-PCR Multiplex-Testing ProPhase Labs Begins Saliva-Based, Viral RT-PCR Multiplex-Testing
    Report: Emergency Use Authorization a Top Health Hazard for 2021 Report: Emergency Use Authorization a Top Health Hazard for 2021
    Rapid Medical Diagnostic Kits Market Size Worth $23.04 Billion By 2027 Rapid Medical Diagnostic Kits Market Size Worth $23.04 Billion By 2027
    Avacta Group and Mologic Enter Commercial Partnership Avacta Group and Mologic Enter Commercial Partnership
    Kardium Receives $115 Million in New Financing for Afib Treatment Kardium Receives $115 Million in New Financing for Afib Treatment
    Use Vertical Integration to Increase Productivity, Drive Innovation Use Vertical Integration to Increase Productivity, Drive Innovation

    Related Breaking News

    • 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


    • Diagnostics
      SmartBreast Corp. Acquires Discover NM750b from GE Healthcare

      SmartBreast Corp. Acquires Discover NM750b from GE Healthcare

      Will manufacture, market, and distribute the Molecular Breast Imaging scanner.
      Charles Sternberg, Assistant Editor 02.09.21

    • Diagnostics
      Rapid Medical Diagnostic Kits Market Size Worth $23.04 Billion By 2027

      Rapid Medical Diagnostic Kits Market Size Worth $23.04 Billion By 2027

      A desire to provide rapid disease treatments is driving the market's growth.
      Michael Barbella, Managing Editor 02.09.21

    • Diagnostics
      Avacta Group and Mologic Enter Commercial Partnership

      Avacta Group and Mologic Enter Commercial Partnership

      Aims to accelerate to market Avacta’s SARS-CoV-2 antigen test and support testing in low and middle income countries.
      Charles Sternberg, Assistant Editor 02.08.21


    • Diagnostics | Digital Health | Software & IT
      Hologic, Google Cloud Begin Collaboration on Next-Gen Dx Tech

      Hologic, Google Cloud Begin Collaboration on Next-Gen Dx Tech

      Enhancing AI and machine learning for breakthrough results in cervical cancer screening.
      Sam Brusco, Associate Editor 02.02.21

    • Diagnostics
      Hologic Launches SuperSonic MACH 20 Ultrasound System

      Hologic Launches SuperSonic MACH 20 Ultrasound System

      Provides added clinical value for general and specialty ultrasound imaging, including of the breast, liver, muscles, and tendons.
      Charles Sternberg, Assistant Editor 01.28.21

    • Cardiovascular | Diagnostics
      Philips Introduces Abdominal Aortic Aneurysm 3D Ultrasound

      Philips Introduces Abdominal Aortic Aneurysm 3D Ultrasound

      3D ultrasound integrated with software for breakthrough in surveillance of abdominal aortic aneurysms.
      Sam Brusco, Associate Editor 01.28.21


    Trending
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • Hardy Diagnostics Releases Rapid Test For COVID-19
    • 5 Ways Plastics Revolutionized The Healthcare Industry
    • FDA Breakthrough Device Designation Given To MI Transcatheter Heart Pump
    • Refurbished Medical Equipment Testing And Certification Under The NEC
    Breaking News
    • January AI Raises $8.8 Million in New Funding
    • FDA Clears Ava Fertility Tracking Wearable Device
    • First Patient in Europe Treated With Diamondback 360 Coronary Orbital Atherectomy System
    • Artificial Intelligence, Machine Learning Adoption in Healthcare to Grow Considerably
    • Japan to Lead APAC Assisted Reproductive Technology Devices Market
    View Breaking News >
    CURRENT ISSUE

    January/February 2021

    • Seeking a Revolution in Clinical Care Through AI
    • Diversifying Supply Chains: New Opportunities Post Pandemic and After Brexit
    • Addition by Subtraction: The Latest of Machining for Medtech
    • Innovation Incubators: An R&D Roundtable
    • Virtual Allies: Electronics Manufacturing Services Providers Offer Real Solutions
    • 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

    Preliminary Study Links Markers of Impaired Bone Health to Vegan Diet
    Refined Grains Linked to Heart Attack Risk, Early Death
    Kappa Bioscience Extends Research Partnership For COVID-19 Research
    Coatings World

    Latest Breaking News From Coatings World

    Nippon Paint Marine Wins Korea Export Award
    Universal Display Corporation, PPG Expand Global Production of UniversalPHOLED Materials
    PPG Introduces Premium Iso-free Primer Surfacer, Catalyst
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    January AI Raises $8.8 Million in New Funding
    FDA Clears Ava Fertility Tracking Wearable Device
    First Patient in Europe Treated With Diamondback 360 Coronary Orbital Atherectomy System
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Spark Therapeutics Appoints CTO
    Cryoport Launches ESG Program
    U.S. Govt. Purchases 100k Doses of Lilly's COVID-19 Antibody Cocktail
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    The Top Beauty Products of 2021, According to HelloGiggles
    Estée Lauder Taps Ana de Armas as Global Brand Ambassador
    Sephora Announces Significant Expansion
    Happi

    Latest Breaking News From Happi

    What You're Reading on Happi.com
    Cosmetic Chemical Sales To Post CAGR 5.8% To 2025
    ACI Urges Senate to Approve Regan as EPA Administrator
    Ink World

    Latest Breaking News From Ink World

    Etiflex Enters New Markets with Nilpeter FA-22 Installation
    Hydrocarbon Solvents Market to Surpass $8.1 Billion by 2030
    Marshall & Bruce Adds Koenig & Bauer Rapida 106 41-Inch Seven-Color Press
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    FTA converts Forum & INFOFLEX to virtual events
    Xeikon launches two new digital label printing presses
    UFlex adds capacity in packaging films
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Texas Medical Technology Partners with My Protect Kit
    Mexico City Single-Use Plastics Ban Leads to Tampon Shortage
    Believe Diapers Launch in U.S.
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Fusion Robotics Receives FDA Clearance for Spinal Navigation and Robotics System
    Kaia Health Unveils Next-Gen Complete MSK Care Solutions
    First Implantation of CTL Amedica's Minimally Invasive Flex Tower
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

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

    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