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  • CDC Expands Negative COVID-19 Test Requirement to All Air Passengers Entering the United States

    Centers for Disease Control and Prevention Expands Negative COVID-19 Test Requirement to All Air Passengers Entering the United States | site |


    (Information contained in Centers for Disease Control and Prevention [CDC] press release: January 12, 2021) The Centers for Disease Control and Prevention is expanding the requirement for a negative COVID-19 test to all air passengers entering the United States. Testing before and after travel is a critical layer to slow the introduction and spread of COVID-19. This strategy is consistent with the current phase of the pandemic and more efficiently protects the health of Americans. Variants of the SARS-CoV-2 virus continue to emerge in countries around the world, and there is evidence of increased transmissibility of some of these variants. With the US already in surge status, the testing requirement for air passengers will help slow the spread of the virus as we work to vaccinate the American public. Before departu...
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  • NIH says Large Clinical Trial will Test Combination Monoclonal Antibody Therapy for mild/moderate COVID-19

    National Institutes of Health says Large Clinical Trial will Test Combination Monoclonal Antibody Therapy for mild/moderate COVID-19 | site |



    (Information contained in National Institutes of Health [NIH] press release: January 5, 2021)

    A Phase 2/3 clinical trial has begun to evaluate a combination investigational monoclonal antibody therapy for its safety and efficacy in people who have mild or moderate COVID-19. The two experimental antibodies, BRII-196 and BRII-198, target SARS-CoV-2, the virus that causes COVID-19. The trial, known as ACTIV-2, is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

    NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program is a public-private partnership to develop a coordinated research strategy for speeding development of the most promising treatments and vaccine candidates. ACTIV-2 is a master protocol
    ...
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  • CDC to Require Negative COVID-19 Test for Air Travelers from the United Kingdom to the U.S.

    Centers for Disease Control and Prevention to Require Negative COVID-19 Test for Air Travelers from the United Kingdom to the U.S. | site |




    (Information contained in Centers for Disease Control and Prevention [CDC] press release dated: December 24, 2020)

    Today, President Trump is taking another step to protect the health of the American people by requiring air passengers arriving from the United Kingdom (U.K.) to test negative, via PCR or Antigen test, no more than 72 hours before departure from the U.K. to the United States.

    The public health authorities in the United Kingdom recently announced the discovery of a new variant of SARS-CoV-2. Viruses constantly change through mutation, and preliminary analysis in the U.K. suggests that this new variant may be up to 70% more transmissible than previously circulating variants.

    On March 14, President Trump issued a Presidential Proclamation to suspend the entry
    ...
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  • Federal Reserve Board releases Second Round of Bank Stress Test Results

    Federal Reserve Board releases Second Round of Bank Stress Test Results

    Federal Reserve Board releases Second Round of Bank Stress Test Results | site |


    (Information contained in Board of Governors of the Federal Reserve System press release dated: December 18, 2020) The Federal Reserve Board on Friday released a second round of bank stress test results this year, which showed that large banks had strong capital levels under two separate hypothetical recessions. "The banking system has been a source of strength during the past year and today's stress test results confirm that large banks could continue to lend to households and businesses even during a sharply adverse future turn in the economy," said Vice Chair for Supervision Randal K. Quarles. The Board's stress tests help ensure that large banks can support the economy during economic downturns. The tests evaluate the resilience of large banks by estimating their losses, revenue, and capital levels—which provide a cushion against losses—under hypothetical scenarios over nine fu...
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  • U.S. Department of Health and Human Services Secretary Azar Statement on EUA for At-Home Use of BinaxNOW Card Test

    U.S. Department of Health and Human Services Secretary Azar Statement on EUA for At-Home Use of BinaxNOW Card Test | site |



    (Information contained in U.S. Department of Health and Human Services [HHS] press release dated: December 16, 2020) On Wednesday, the Food and Drug Administration issued a new emergency use authorization (EUA) for Abbott’s BinaxNOW COVID-19 Ag Card Home Test, allowing individuals to perform the test at home with a prescription. The test will be offered in partnership with a telehealth service that will guide users step-by-step and report all test results to the relevant public health authorities in accordance with local, state and federal requirements HHS Secretary Alex Azar issued the following statement: “FDA’s authorization of the BinaxNOW card test for home use means we should have tens of millions of COVID-19 tests in the coming months that Americans can use without leaving their home. HHS’s testing leadership ha...
    See more | Go to post

  • FDA Coronavirus COVID-19 Update - - - FDA Issues New Authorization for the BinaxNOW COVID-19 Ag Card Home Test

    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: FDA Issues New Authorization for the BinaxNOW COVID-19 Ag Card Home Test | site |



    (Information contained in U.S. Food and Drug Administration [FDA] press release: December 16, 2020) Today, the U.S. Food and Drug Administration issued a new emergency use authorization (EUA) for the BinaxNOW COVID-19 Ag Card Home Test which is authorized for use by patients at home with a prescription. The BinaxNOW COVID-19 Ag Card Home Test is authorized for prescription use at home with self-collected nasal swab samples from individuals ages 15 years or older who are suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset. It is also authorized for use with adult-collected nasal swab samples from individuals ages four years or older who are suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset. The test will b...
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  • HHS Secretary Azar Statement on FDA Authorization of First Fully At-Home, Over-the-Counter COVID-19 Test

    U.S. Department of Health and Human Services Secretary Azar Statement on FDA Authorization of First Fully At-Home, Over-the-Counter COVID-19 Test | site |



    (The following information was contained in U.S. Department of Health and Human Services [HHS] press release: December 15, 2020) On Tuesday, the 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 that does not require a prescription, the Ellume COVID-19 Home Test, which was developed with $30 million in support from the NIH’s RADx Tech program. HHS Secretary Alex Azar issued the following statement: “FDA has authorized the first COVID-19 test that you can purchase over-the-counter, take at home, and get a rapid result, representing a major breakthrough for Americans’ ever-expanding access to convenient COVID-19 testing options. HHS provided support for this new option through NIH’s RADx in...
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  • FDA Coronavirus COVID-19 Update - - - FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19

    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19 | site |


    Test is authorized for individuals two years of age or older, including those not showing symptoms


    (Information contained in U.S. Food and Drug Administration [FDA] press release: December 15, 2020)

    Today, 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-c
    ...
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  • NIH-funded COVID-19 Home Test is First to receive Over-the-counter Authorization from FDA

    National Institutes of Health-funded COVID-19 Home Test is First to receive Over-the-counter Authorization from FDA | site |


    Ellume USA’s rapid at-home test was developed through the NIH RADx Initiative.


    (Information contained in National Institutes of Health [NIH] press release: December 15, 2020)

    The U.S. Food and Drug Administration granted emergency use authorization (EUA) today for an innovative COVID-19 viral antigen test developed with support from the National Institutes of Health’s Rapid Acceleration of Diagnostics (RADx) Initiative. Ellume USA LLC, Valencia, California, designed the test for use at home without a prescription. This is the first EUA awarded for an at-home COVID test that can be purchased over the counter. Ellume developed the test with a $30 million contract and technical support from the RADx Tech program, managed by the National Institute of Biomedical Imaging and Bioengineering (NIBIB), part...
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  • U.S. Food and Drug Administration Coronavirus COVID-19 Update - - - FDA Authorizes First Direct-to-Consumer COVID-19 Test System

    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: FDA Authorizes First Direct-to-Consumer COVID-19 Test System | site |


    Test system is authorized for at-home sample collection with laboratory test processing


    (Information contained in U.S. Food and Drug Administration [FDA] press release: December 9, 2020) Today, the U.S. Food and Drug Administration authorized LabCorp’s Pixel COVID-19 Test Home Collection Kit for use by any individual 18 years and older without a prescription. This product, which is authorized as the first COVID-19 direct-to-consumer (non-prescription) test system, allows an individual to self-collect a nasal swab sample at home and then send that sample for testing to LabCorp. Positive or invalid test results are then delivered to the user by phone call from a health care provider. Negative test results are delivered via email or online portal. This home sample collection kit can be purchased online or in ...
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  • FDA Coronavirus COVID-19 Update - - - FDA Authorizes First COVID-19 and Flu Combination Test for use with Home-collected Samples

    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 and Flu Combination Test for use with Home-collected Samples | site |


    (Information contained in U.S. Food and Drug Administration [FDA] press release: December 4, 2020) Today, the U.S. Food and Drug Administration authorized the first diagnostic test for at home collection of patient samples to detect both COVID-19 and influenza A and B (flu). The FDA authorized Quest Diagnostics RC COVID-19 +Flu RT-PCR Test for prescription use with the Quest Diagnostics Self-Collection Kit for COVID-19 +Flu by individuals who are suspected of respiratory viral infection consistent with COVID-19 when home collection is determined to be appropriate by an individual’s healthcare provider. Under a health care provider’s order, patients can collect a sample at home and ship it to a Quest Diagnostics laboratory for analysis following the instructions included with the self-collec...
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  • HHS Launches Pilot Program of Fast Molecular POC Test for COVID-19

    HHS Launches Pilot Program of Fast Molecular POC Test for COVID-19

    U.S. Department of Health and Human Services Launches Pilot Program of Fast Molecular POC Test for COVID-19 | site |


    HHS says Alaska, Florida, Louisiana, New Jersey, and Texas Receive First Shipments of Test Used in NBA Bubble


    (Information contained in HHS press release: November 19, 2020) The U.S. Department of Health and Human Services (HHS) has launched a pilot program with five states to use portable, cartridge-based COVID-19 molecular test kits that provide rapid results. The pilot program will assess how to best integrate diagnostic technology developed by Cue Health, Inc., into strategies for disease surveillance and infection control in institutions such as nursing homes. Used successfully as the primary molecular point-of-care (POC) test to control the spread of COVID-19 within in the National Basketball Association “bubble,” as well as by leading healthcare providers in the U.S., the nasal swab POC test generates results in ab...
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  • HHS Secretary Alex Azar Statement on FDA Authorization of First COVID-19 Test for Home Self-Tests

    U.S. Health and Human Services Secretary Alex Azar Statement on FDA Authorization of First COVID-19 Test for Home Self-Tests | site |




    (November 17, 2020) - - On November 17, 2020 the U.S. Department of Health and Human Services (HHS) published the following information: On Tuesday, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the first COVID-19 diagnostic at-home test, the Lucira COVID-19 All-In-One Test Kit, a molecular test that provides results in 30 minutes or less and is authorized for use by prescription only. HHS Secretary Alex Azar issued the following statement: “Making it possible for Americans to do their own rapid COVID-19 self-test at home by prescription is the latest addition to our constantly expanding arsenal of COVID-19 testing options. The Trump Administration has built the world’s largest testing system, and we will continue supporting both the development and manufacturing of cuttin...
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  • FDA Coronavirus COVID-19 Update - - - FDA Authorizes First COVID-19 Test for Self-Testing at Home

    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test for Self-Testing at Home | site |




    (November 17, 2020) - - On November 17, 2020 the U.S. Food and Drug Administration (FDA) published the following information:

    Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home and that provides rapid results. The Lucira COVID-19 All-In-One Test Kit is a molecular (real-time loop mediated amplification reaction) single use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19. “The FDA continues to demonstrate its unprecedented speed in response to the pandemic. While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home. This new testing option is an important diagnostic
    ...
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  • Coronavirus - - COVID-19 - - Update: FDA Authorizes First Test that Detects Neutralizing Antibodies from Recent or Prior SARS-CoV-2 Infection

    Coronavirus (COVID-19) Update: FDA Authorizes First Test that Detects Neutralizing Antibodies from Recent or Prior SARS-CoV-2 Infection| site |


    (November 6, 2020) - - On November 6, 2020 the U.S. Food and Drug Administration (FDA) published the following information:

    Today, the U.S. Food and Drug Administration authorized the first serology test that detects neutralizing antibodies from recent or prior SARS-CoV-2 infection, which are antibodies that bind to a specific part of a pathogen and have been observed in a laboratory setting to decrease SARS-CoV-2 viral infection of cells. The FDA issued an emergency use authorization (EUA) for the cPass SARS-CoV-2 Neutralization Antibody Detection Kit, which specifically detects this type of antibody. Although the FDA has previously issued EUAs to more than 50 antibody (serology) tests, those tests only detect the presence of binding antibodies. Binding antibodies bind to a pathogen, such as a virus, but ...
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  • Staff Reporter 1
    CDC Expands Negative COVID-19 Test Requirement to All Air Passengers Entering the United States
    by Staff Reporter 1
    Centers for Disease Control and Prevention Expands Negative COVID-19 Test Requirement to All Air Passengers Entering the United States | site |


    (Information contained in Centers for Disease Control and Prevention [CDC] press release: January 12, 2021) The Centers for Disease Control and Prevention is expanding the requirement for a negative COVID-19 test to all air passengers entering the United States. Testing before and after travel is a critical layer to slow the introduction and spread of COVID-19. This strategy is consistent with the current phase of the pandemic and more efficiently protects the health of Americans. Variants of the SARS-CoV-2 virus continue to emerge in countries around the world, and there is evidence of increased transmissibility of some of these variants. With the US already in surge status, the testing requirement for air passengers will help slow the spread of the virus as we work to vaccinate the American public. Before departu...
    01-13-2021, 07:20 AM
  • Staff Reporter 1
    NIH says Large Clinical Trial will Test Combination Monoclonal Antibody Therapy for mild/moderate COVID-19
    by Staff Reporter 1
    National Institutes of Health says Large Clinical Trial will Test Combination Monoclonal Antibody Therapy for mild/moderate COVID-19 | site |



    (Information contained in National Institutes of Health [NIH] press release: January 5, 2021)

    A Phase 2/3 clinical trial has begun to evaluate a combination investigational monoclonal antibody therapy for its safety and efficacy in people who have mild or moderate COVID-19. The two experimental antibodies, BRII-196 and BRII-198, target SARS-CoV-2, the virus that causes COVID-19. The trial, known as ACTIV-2, is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

    NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program is a public-private partnership to develop a coordinated research strategy for speeding development of the most promising treatments and vaccine candidates. ACTIV-2 is a master protocol
    ...
    01-06-2021, 02:56 AM
  • Staff Reporter 1
    CDC to Require Negative COVID-19 Test for Air Travelers from the United Kingdom to the U.S.
    by Staff Reporter 1
    Centers for Disease Control and Prevention to Require Negative COVID-19 Test for Air Travelers from the United Kingdom to the U.S. | site |




    (Information contained in Centers for Disease Control and Prevention [CDC] press release dated: December 24, 2020)

    Today, President Trump is taking another step to protect the health of the American people by requiring air passengers arriving from the United Kingdom (U.K.) to test negative, via PCR or Antigen test, no more than 72 hours before departure from the U.K. to the United States.

    The public health authorities in the United Kingdom recently announced the discovery of a new variant of SARS-CoV-2. Viruses constantly change through mutation, and preliminary analysis in the U.K. suggests that this new variant may be up to 70% more transmissible than previously circulating variants.

    On March 14, President Trump issued a Presidential Proclamation to suspend the entry
    ...
    12-26-2020, 09:23 PM
  • Staff Reporter 1
    Federal Reserve Board releases Second Round of Bank Stress Test Results
    by Staff Reporter 1
    Federal Reserve Board releases Second Round of Bank Stress Test Results | site |


    (Information contained in Board of Governors of the Federal Reserve System press release dated: December 18, 2020) The Federal Reserve Board on Friday released a second round of bank stress test results this year, which showed that large banks had strong capital levels under two separate hypothetical recessions. "The banking system has been a source of strength during the past year and today's stress test results confirm that large banks could continue to lend to households and businesses even during a sharply adverse future turn in the economy," said Vice Chair for Supervision Randal K. Quarles. The Board's stress tests help ensure that large banks can support the economy during economic downturns. The tests evaluate the resilience of large banks by estimating their losses, revenue, and capital levels—which provide a cushion against losses—under hypothetical scenarios over nine fu...
    12-21-2020, 05:59 PM
  • Staff Reporter 1
    U.S. Department of Health and Human Services Secretary Azar Statement on EUA for At-Home Use of BinaxNOW Card Test
    by Staff Reporter 1
    U.S. Department of Health and Human Services Secretary Azar Statement on EUA for At-Home Use of BinaxNOW Card Test | site |



    (Information contained in U.S. Department of Health and Human Services [HHS] press release dated: December 16, 2020) On Wednesday, the Food and Drug Administration issued a new emergency use authorization (EUA) for Abbott’s BinaxNOW COVID-19 Ag Card Home Test, allowing individuals to perform the test at home with a prescription. The test will be offered in partnership with a telehealth service that will guide users step-by-step and report all test results to the relevant public health authorities in accordance with local, state and federal requirements HHS Secretary Alex Azar issued the following statement: “FDA’s authorization of the BinaxNOW card test for home use means we should have tens of millions of COVID-19 tests in the coming months that Americans can use without leaving their home. HHS’s testing leadership ha...
    12-18-2020, 01:45 PM

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