Rapid antigen test

Gauss Partners with State of California on New COVID-19 Antibody Study

Retrieved on: 
Thursday, April 22, 2021

The California Department of Public Health will mail letters to more than 200,000 households asking them to take part in this study.

Key Points: 
  • The California Department of Public Health will mail letters to more than 200,000 households asking them to take part in this study.
  • The app is designed to guide patients to properly self-administer a nasal swab and perform the rapid antigen test.
  • Gauss is a recipient of the Apple Design Award, which recognizes the best in design, innovation, and technology on Apple platforms.
  • In September 2020, Gauss announced a partnership with Cellex, Inc. to develop a rapid at-home test for COVID-19.

Avacta Receives Clinical Validation of AffiDX SARS-CoV-2 Antigen Lateral Flow Test

Retrieved on: 
Tuesday, April 20, 2021

b'Avacta Group plc (AIM: AVCT), the developer of diagnostics and innovative cancer therapies based on its proprietary Affimer\xc2\xae and pre|CISION\xe2\x84\xa2 platforms, is pleased to announce positive data from the clinical validation of its AffiDX\xc2\xae SARS-CoV-2 antigen lateral flow test.

Key Points: 
  • b'Avacta Group plc (AIM: AVCT), the developer of diagnostics and innovative cancer therapies based on its proprietary Affimer\xc2\xae and pre|CISION\xe2\x84\xa2 platforms, is pleased to announce positive data from the clinical validation of its AffiDX\xc2\xae SARS-CoV-2 antigen lateral flow test.
  • These data will now be combined with stability and other performance data from ongoing studies to finalise the technical file for CE marking the AffiDX SARS-CoV-2 antigen lateral flow test for professional use, allowing the Company to begin commercial roll-out in Europe in May.\nThe clinical evaluation of Avacta\xe2\x80\x99s lateral flow test was carried out at a single site in Europe with patient samples with viral loads confirmed by PCR.
  • Avacta\xe2\x80\x99s rapid antigen test identified 96/98 of these correctly as positive with a 20 minutes read time resulting in a clinical sensitivity of 98.0% for samples within this broad range down to low viral loads.
  • The clinical data for Avacta\xe2\x80\x99s AffiDX\xc2\xae SARS-CoV-2 antigen lateral flow test demonstrated 100% sensitivity for identifying infectious individuals in this range.\nDr Alastair Smith, Chief Executive of Avacta Group commented: \xe2\x80\x9cI am delighted with the clinical data from this larger clinical study, which has robustly evaluated the AffiDX antigen test with lower viral loads of Ct>26 as well as with higher viral load samples.

eMed and State of Colorado Partnership Expands Availability of Free At-Home COVID-19 Rapid Testing

Retrieved on: 
Tuesday, April 13, 2021

b'MIAMI, April 13, 2021 /PRNewswire/ -- eMed , a digital health company democratizing healthcare through its digital-point-of-care platform, announces a new milestone in its State of Colorado partnership: At-home COVID-19 rapid testing availability has now been expanded to all employees required to interact with the public at their jobs.

Key Points: 
  • b'MIAMI, April 13, 2021 /PRNewswire/ -- eMed , a digital health company democratizing healthcare through its digital-point-of-care platform, announces a new milestone in its State of Colorado partnership: At-home COVID-19 rapid testing availability has now been expanded to all employees required to interact with the public at their jobs.
  • Now, more Coloradans have access to free rapid antigen testing at home with validated results in just minutes.\neMed, the architect behind the first virtually guided, rapid at-home COVID-19 test technology and platform, partnered with the State of Colorado earlier this year to distribute and administer millions of rapid tests with verified results to teachers, staff and selected students .
  • "eMed provides a unique at-home testing solution that is not only convenient, but reliable with third-party verified results a key component in the public health fight to combat this pandemic.
  • 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.\nView original content to download multimedia: http://www.prnewswire.com/news-releases/emed-and-state-of-colorado-partn...\n'

eMed and Truepill Partner to Distribute COVID-19 Rapid At-Home BinaxNOW Antigen Test

Retrieved on: 
Tuesday, April 13, 2021

eMed\'s unique digital health care services will now connect Truepill customers with an at-home COVID-19 rapid antigen test , a vital component for any workplace safety initiative.\neMed\'s partnership with Truepill provides a new distribution channel for companies looking to access the BinaxNOW COVID-19 Ag Card Home Test.

Key Points: 
  • eMed\'s unique digital health care services will now connect Truepill customers with an at-home COVID-19 rapid antigen test , a vital component for any workplace safety initiative.\neMed\'s partnership with Truepill provides a new distribution channel for companies looking to access the BinaxNOW COVID-19 Ag Card Home Test.
  • Whether through the COVID-19 workplace safety platform, or as an independent purchase order, Truepill\'s nimble logistics provide a uniquely customizable solution.
  • Test users are led and supervised through the testing process remotely by an eMed Certified Guide, who authenticates the test and result, and reports results to the appropriate public health authorities.
  • We\'re thrilled to partner with industry innovator eMed to lead the charge and deliver solutions that everyone can rely on.

HealthBar Becomes AditxtScore™ Channel Partner to Offer AditxtScore™ for COVID-19 Immunity Status Monitoring to Complement its Concierge and Drive-Thru Testing Services

Retrieved on: 
Tuesday, April 6, 2021

The company offers drive-thru and concierge COVID-19 testing, including rapid, PCR, antibody, and antigen tests.

Key Points: 
  • The company offers drive-thru and concierge COVID-19 testing, including rapid, PCR, antibody, and antigen tests.
  • HealthBar also partners with organizations to provide at-location testing for employees as well as an expanding menu of medical services.
  • As an AditxtScoreChannel Partner, HealthBar will now offer its consumer and employer clients AditxtScorefor COVID-19 as an immune monitoring service.
  • This service will complement HealthBar's current offerings and provide key information regarding immunity status.

Medivolve Subsidiary Collection Sites Provides March Sales Update With Total Sales of 20,574 Tests at an Average Price of $99 per Test

Retrieved on: 
Tuesday, April 6, 2021

TORONTO, April 06, 2021 (GLOBE NEWSWIRE) -- Medivolve Inc.(Medivolve) (NEO:MEDV; OTC:COPRF; FRA:4NC) is pleased to provide a sales update for its wholly owned subsidiary, Collection Sites, LLC.

Key Points: 
  • TORONTO, April 06, 2021 (GLOBE NEWSWIRE) -- Medivolve Inc.(Medivolve) (NEO:MEDV; OTC:COPRF; FRA:4NC) is pleased to provide a sales update for its wholly owned subsidiary, Collection Sites, LLC.
  • During the month of March, Collection Sites realized the sale of 20,574 tests at an average selling price of $99 per test across its network.
  • The Company continued to see the strongest demand for antigen tests, followed by antibody and then PCR tests.
  • March was another solid month of sales for Collection Sites with over 20,000 tests conducted across our network.

Quidel’s Sofia® SARS Antigen Test Receives Emergency Use Authorization for Screening Use With Serial Testing

Retrieved on: 
Friday, April 2, 2021

This new intended use allows the Sofia SARS Antigen FIA to be used among asymptomatic individuals and run without a prescription provided that individuals test twice within 24-36 hours.

Key Points: 
  • This new intended use allows the Sofia SARS Antigen FIA to be used among asymptomatic individuals and run without a prescription provided that individuals test twice within 24-36 hours.
  • Clinical studies in asymptomatic patients undergoing serial testing are ongoing to establish the clinical performance.
  • Broadscale application of our Sofia rapid antigen test for COVID-19 screening will catch asymptomatic cases early and limit virus spread.
  • The Sofia SARS Antigen FIA is only for use under the Food and Drug Administrations Emergency Use Authorization.

BD Receives Emergency Use Authorization for Asymptomatic Screening for SARS-CoV-2 through Serial Rapid Antigen Testing

Retrieved on: 
Thursday, April 1, 2021

Articles and studies in multiple peer-reviewed publications including the New England Journal of Medicine1 and the British Medical Journal2 have touted the benefits of serial, rapid antigen testing.

Key Points: 
  • Articles and studies in multiple peer-reviewed publications including the New England Journal of Medicine1 and the British Medical Journal2 have touted the benefits of serial, rapid antigen testing.
  • The EUA for the BD Veritor Plus System includes SARS-CoV-2 screening through serial testing of asymptomatic individuals when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests.
  • Serial testing on the BD Veritor Plus System can be performed in any setting with a CLIA certificate of waiver.
  • Serial COVID-19 testing in everyday settings presents challenges in managing test subject demographics and reporting results to public health authorities.

Abbott's BinaxNOW™ Rapid Antigen Self Test Receives FDA Emergency Use Authorization for Asymptomatic, Over-the-Counter, Non-Prescription, Multi-Test Use

Retrieved on: 
Thursday, April 1, 2021

The BinaxNOW Self Test is the same technology as the existing BinaxNOW test that has been available since August 2020 but is indicated by the FDA for serial asymptomatic testing, meaning that people should test themselves frequently.

Key Points: 
  • The BinaxNOW Self Test is the same technology as the existing BinaxNOW test that has been available since August 2020 but is indicated by the FDA for serial asymptomatic testing, meaning that people should test themselves frequently.
  • The BinaxNOW COVID-19 Ag Card Self Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2.
  • BinaxNOW COVID-19 Ag Card Self Test is only for use under the Food and Drug Administration's Emergency Use Authorization.
  • The BinaxNOW COVID-19 Ag Card 2 Home Test is to be performed only with the supervision of a telehealth proctor.

Pitt County Residents Offered Free, Rapid, Self-Administered COVID-19 Tests

Retrieved on: 
Wednesday, March 31, 2021

COVID Test At-Home Testing Challenge, which provides residents of Greenville and Pitt County access to free, rapid COVID-19 tests that they can self-administer in the comfort of their home.

Key Points: 
  • COVID Test At-Home Testing Challenge, which provides residents of Greenville and Pitt County access to free, rapid COVID-19 tests that they can self-administer in the comfort of their home.
  • COVID Test encourages GreenvillePitt County residents to use the tests three times a week, regardless of symptoms, to reduce the spread of COVID-19 and keep the community healthy.
  • GreenvillePitt County residents can order test kits or view the list of community pick-up locations by visiting the website at www.CovidTestPittCounty.org .
  • COVID Test At-Home Testing Challenge, contact Amy Hattem, Pitt County Health Department Deputy Director at [email protected] .