Viral disease testing

Global WholeHealth Partners Corp (OTC:GWHP) Receives a Second Order for 10,000 Tests From Salud Previa of Tijuana, MX; Salud Previa has Ordered Over 30,000 Tests Now; Tests Sold Were Pregnancy Tests, Drug Tests, Dengue Fever, TB and COVID

Retrieved on: 
Tuesday, July 20, 2021

The Global WholeHealth Partners Corp (OTC:GWHP)COVID 19 Antigen and Antibody test can pick up the DELTA Variant.

Key Points: 
  • The Global WholeHealth Partners Corp (OTC:GWHP)COVID 19 Antigen and Antibody test can pick up the DELTA Variant.
  • Global WholeHealth Partners Corp. (OTC: GWHP) offers one of the largest lines of COVID 19 tests.
  • Global WholeHealth Partners Corp (OTC: GWHP) states that the Antibody IgG/IgM tests that they offer are capable of detecting all the current identified SARS-CoV-2 viruses.
  • Global WholeHealth Partners recognizes that there is a crucial need for faster testing and faster results when it comes to fighting the COVID.

FDA issues Emergency Use Authorization for CovAb™ SARS-CoV-2 Ab Test, the oral fluid rapid test for SARS-CoV-2 antibodies

Retrieved on: 
Thursday, June 24, 2021

CovAb, the only oral fluid rapid, Pan Ig antibody test for Covid-19 gets FDA Emergency Use Authorization

Key Points: 
  • CovAb, the only oral fluid rapid, Pan Ig antibody test for Covid-19 gets FDA Emergency Use Authorization
    CovAb is the first and only rapid, oral fluid-based, point-of-care antibody test authorized by the FDA for use under an EUA.
  • In addition to being rapid and noninvasive, the CovAb test has sensitivity of 97.6% and specificity of 98.8%.
  • The CovAb test was developed based on Diabetomics' expertise in oral fluid and autoantibody diagnostics developed for its core service areas of diabetes and fetal-maternal disease.
  • The CovAb test is available for sale through Diabetomics' subsidiary COVYDx, Inc.
    View original content to download multimedia: http://www.prnewswire.com/news-releases/fda-issues-emergency-use-authori...

Roche receives FDA authorisation for testing of asymptomatic people with the cobas SARS-CoV-2 Test to help control the spread of COVID-19

Retrieved on: 
Tuesday, May 18, 2021

"\nAsymptomatic testing with the cobas SARS-CoV-2 Test is also available in countries accepting the CE mark.

Key Points: 
  • "\nAsymptomatic testing with the cobas SARS-CoV-2 Test is also available in countries accepting the CE mark.
  • It has been authorised by the FDA under an EUA for use by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C.
  • The test has been authorised only for the detection of RNA from SARS-CoV-2 virus and diagnosis of SARS-CoV-2 virus infection, not for any other viruses or pathogens.
  • Specimens with low SARS-CoV-2 RNA concentrations may not be detected in sample pools due to the decreased sensitivity of pooled testing.

Roche receives FDA authorisation for testing of asymptomatic people with the cobas SARS-CoV-2 Test to help control the spread of COVID-19

Retrieved on: 
Tuesday, May 18, 2021

"\nAsymptomatic testing with the cobas SARS-CoV-2 Test is also available in countries accepting the CE mark.

Key Points: 
  • "\nAsymptomatic testing with the cobas SARS-CoV-2 Test is also available in countries accepting the CE mark.
  • It has been authorised by the FDA under an EUA for use by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C.
  • The test has been authorised only for the detection of RNA from SARS-CoV-2 virus and diagnosis of SARS-CoV-2 virus infection, not for any other viruses or pathogens.
  • Specimens with low SARS-CoV-2 RNA concentrations may not be detected in sample pools due to the decreased sensitivity of pooled testing.

LumiraDx Receives Reissued FDA Emergency Use Authorization for Its High Sensitivity, Rapid COVID-19 Molecular Lab Test

Retrieved on: 
Tuesday, April 13, 2021

In 2020, the technology was used to launch Fast Lab Solutions a dedicated business unit to help address the COVID-19 testing crisis by expanding existing laboratory capacity.

Key Points: 
  • In 2020, the technology was used to launch Fast Lab Solutions a dedicated business unit to help address the COVID-19 testing crisis by expanding existing laboratory capacity.
  • "\nSARS-CoV-2 RNA STAR Complete received an EUA from the FDA on October 14, 2020 and LumiraDx plans to complete the process to obtain CE Mark.
  • TheLumiraDx Platform is designed to deliver lab comparable diagnostic results at the point of care in minutes.
  • It is designed to be affordable and accessible for healthcare providers globally, and to strengthen community-based healthcare.\n'

LumiraDx Receives Reissued FDA Emergency Use Authorization for Its High Sensitivity, Rapid COVID-19 Molecular Lab Test

Retrieved on: 
Tuesday, April 13, 2021

In 2020, the technology was used to launch Fast Lab Solutions a dedicated business unit to help address the COVID-19 testing crisis by expanding existing laboratory capacity.

Key Points: 
  • In 2020, the technology was used to launch Fast Lab Solutions a dedicated business unit to help address the COVID-19 testing crisis by expanding existing laboratory capacity.
  • "\nSARS-CoV-2 RNA STAR Complete received an EUA from the FDA on October 14, 2020 and LumiraDx plans to complete the process to obtain CE Mark.
  • TheLumiraDx Platform is designed to deliver lab comparable diagnostic results at the point of care in minutes.
  • It is designed to be affordable and accessible for healthcare providers globally, and to strengthen community-based healthcare.\n'

Quidel’s QuickVue® At-Home OTC COVID-19 Test Receives Emergency Use Authorization for Screening Use With Serial Testing

Retrieved on: 
Thursday, April 1, 2021

Additional information regarding the intended use of the QuickVue At-Home OTC COVID-19 Test can be found at www.quidel.com .

Key Points: 
  • Additional information regarding the intended use of the QuickVue At-Home OTC COVID-19 Test can be found at www.quidel.com .
  • This EUA allows the QuickVue At-Home OTC COVID-19 Test to be used among asymptomatic individuals and run without a prescription provided that individuals test twice within 24-36 hours.
  • In 1999, QuickVue Influenza A+B was the first visually read rapid test approved by the FDA for professional use.
  • The QuickVue At-Home OTC COVID-19 Test is only for use under the Food and Drug Administrations Emergency Use Authorization.

XpresSpa Group Announces Rapid PCR Testing Option to Expedite COVID-19 Testing Results In Real Time for More Airline Passengers

Retrieved on: 
Monday, March 29, 2021

Theaddition will enableXpresCheckto increase the availability ofrapid PCRbasedCOVID-19testsatXpresCheckairportsites, starting with pilots atJohn F. Kennedy International Airport today and George Bush Intercontinental Airport in Houston next week.

Key Points: 
  • Theaddition will enableXpresCheckto increase the availability ofrapid PCRbasedCOVID-19testsatXpresCheckairportsites, starting with pilots atJohn F. Kennedy International Airport today and George Bush Intercontinental Airport in Houston next week.
  • XpresCheck will be offering the Accula SARS-CoV-2 Test from Thermo Fisher Scientific.The testing protocol has received an Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) and provides results in 30 minutes.
  • XpresCheck is committed to helping protect Americasairports and the health of everyone who works within or passes through them with fast, accurate COVID-19 testing right at the airport.
  • This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.

Abbott Receives FDA EUA for Laboratory PCR Assay That Detects and Differentiates SARS-CoV-2, Flu A, Flu B and RSV in One Test - and FDA EUA for Asymptomatic Usage of Alinity m COVID-19 Test

Retrieved on: 
Friday, March 5, 2021

Test will run on Abbott's Alinity m system the company's most advanced high-volume laboratory molecular instrument.

Key Points: 
  • Test will run on Abbott's Alinity m system the company's most advanced high-volume laboratory molecular instrument.
  • Alinity m uses Polymerase Chain Reaction (PCR) technology, which is known for its high sensitivity in detecting infectious diseases.
  • To help fight the pandemic, Abbott has accelerated placements of the Alinity m system in hospital labs, academic centers and labs that are critical to patient care.
  • The updated Alinity m SARS-CoV-2 test, Alinity m Resp-4-Plex assay, and Abbott's existing testing technologies willnow allbe available to support front-line healthcare workers.

New COVID-19 Antibody Test Receives Emergency Use Authorization by the FDA

Retrieved on: 
Wednesday, February 3, 2021

The revolutionary test has received an emergency use authorization from the U.S. Food & Drug Administration.

Key Points: 
  • The revolutionary test has received an emergency use authorization from the U.S. Food & Drug Administration.
  • FDA issues emergency use authorization for new COVID-19 antibody test that can predict severity of symptoms of the virus.
  • "This antibody test has more test points than others that have been approved by the FDA," says Lotta Granholm-Bentley, the founding executive director of the Knoebel Institute and one of the project's lead researchers.
  • The antibody test could be used to identify individuals who have been exposed to COVID-19 but have been asymptomatic.