Tag Archives: COVID-19

For Patients Confirmed With COVID-19 – U.S. Food and Drug Administration (FDA) Has Issued an Emergency Use Authorization (EUA) for the Elecsys® IL-6 Test

Roche’s Elecsys IL-6 test receives FDA Emergency Use Authorization to help in identifying patients at high risk of severe inflammatory response

  • FDA EUA1 now makes IL-6 testing accessible to patients in the United States to assist in identifying severe inflammatory response in patients with confirmed COVID-19 and is also available in markets accepting the CE-mark2
  • Interleukin 6 (IL-6) is an early indicator for acute inflammation to aid in the management of critically ill patients
  • This test is available on Roche’s cobas e analysers which are widely available around the world

 
Roche announced on June 4, 2020 that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the Elecsys® IL-6 test. This test measures levels of the biomarker interleukin 6 (IL-6) and can be used to help identify patients with confirmed COVID-19 disease who could be at high risk of intubation with mechanical ventilation.

The test can support physicians, in combination with other examinations and vital signs, to decide early on if a patient with confirmed COVID-19 illness requires mechanical ventilation.“The FDA EUA approval of Elecsys IL-6 is another step in our commitment to deliver fast and reliable diagnostic tests to help fight the coronavirus pandemic,” said Thomas Schinecker, CEO Roche Diagnostics. “In the current situation, time is specifically critical. The test could help physicians in the quick identification of severe inflammatory response in patients infected with the SARS CoV-2 virus.”

“In the current pandemic, Roche’s Elecsys IL-6 test was helpful as an early indicator for acute inflammation and in the management of critically ill patients,” said Tobias Herold, MD from the Emergency Department, University Hospital, LMU University Munich, Germany. “Elevated IL-6 values help us to identify patients with a high risk of upcoming respiratory failure.

Hospitals and reference laboratories can run the Elecsys IL-6 test on Roche’s cobas e® analysers which are widely available around the world. These fully-automated systems can provide test results in approximately 18 minutes, with a test throughput of up to 300 tests/hour, depending on the analyser.

About Elecsys IL-6
The IL-6 immunoassay is an in vitro diagnostic test for the quantitative determination of IL-6 (interleukin-6) in human serum or plasma. This assay is used in countries accepting CE-mark to aid in the management of critically ill patients, as an early indicator for acute inflammation. Under the Emergency Use Authorization in the US, this assay can be used to assist in identifying severe inflammatory response in patients with confirmed COVID‑19 illness to aid in determining the risk of intubation with mechanical ventilation, in conjunction with clinical findings and the results of other laboratory testing. IL-6 is released by immune cells, once they are activated by virus, bacteria or other immune cells. IL-6 acts like a messenger to activate other immune cells to fight the infection. Because IL-6 is released so early during a severe infection, it helps physicians to identify severely ill COVID-19 patients as early as possible. Hospitals and reference laboratories can run the test on Roche’s cobas e analysers which are widely available around the world. These fully-automated systems can provide test results in approximately 18 minutes, with a test throughput of up to 300 tests/hour, depending on the analyser.

About Roche’s response to the COVID-19 pandemic
The COVID-19 pandemic continues to evolve globally with varying developments from country to country and we are partnering with healthcare providers, laboratories, authorities and organisations to help make sure that patients receive the tests, treatment and care they need.

Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic. On 13 March we received FDA Emergency Use Authorization for a high-volume molecular test to detect SARS-CoV-2, the virus that causes COVID-19, which is also available in countries accepting the CE Mark. On 3 May, Roche announced that its COVID-19 antibody test, aimed at detecting the presence of antibodies in the blood, also received FDA Emergency Use Authorization and is available in markets accepting the CE mark. Our existing diagnostics portfolio for critical care has also been playing a significant role in supporting patient management during the COVID-19 crisis, with our blood gas and sepsis products being used to monitor patients in the acute setting. Roche is working closely with governments and health authorities around the world, and has significantly increased production to help ensure availability of tests globally.

While there are currently no approved medicines for the treatment of patients with COVID-19, we are actively involved in understanding the potential of our existing portfolio and are researching options for the future. On 19 March, we announced the initiation of COVACTA – a global Phase III randomised, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of intravenous Actemra©/RoActemra© (tocilizumab) plus standard of care in hospitalised adult patients with severe COVID-19 pneumonia compared to placebo plus standard of care. Roche has also initiated an internal early research programme focused on the development of medicines for COVID-19 and is evaluating a large number of potential collaborations.

In these exceptional times, Roche stands together with governments, healthcare providers and all those working to overcome the pandemic.

About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of medical countermeasures needed during public health emergencies https://www.fda.gov/home
[2] CE-IVD marking is granted through completion of a comprehensive technical validation and self declaration under the European Directive for In Vitro Diagnostic Medical Devices.

Microbiota Restoration in Recurrent C. difficile and COVID-19 : Sponsored by ACHL Academy for Continued Healthcare Learning Activity

Microbiota Restoration in Recurrent C. difficile (C. diff. ) and COVID-19

 

 

 

Please click on the following link to be redirected to the activity

(Expires on September 6, 2020)

https://www.achlcme.org/COVID-19-MicrobiotaRestoration

C. diff. Spores and More Live Broadcast, Tuesday, May 5th With Guest Maureen Spencer, RN, M.Ed., CIC to Discuss Coronavirus (COVID-19) A Time To Review the Basics Through Prevention, and Symptom Part II

Join Us on Tuesday, May 5th, 2020

1:00 p.m. EST

with Guest:  Maureen Spencer, RN, M.Ed., CIC

 

 

 

 

 

 

 

As We Continue Discussing:

Coronavirus COVID-19  –    A Time To Review the Basics Through Prevention, and Symptoms—  Part II

www.cdiffradio.com

Episode Description

The 2019–20 coronavirus pandemic is a pandemic of coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The disease was first identified in Wuhan, Hubei, China in December 2019. Join Our Guest: Maureen Spencer, RN, M.Ed, CIC, will be joining us to continue discussing the coronavirus (COVID-19) through Prevention, Symptoms, and the global healthcare focus.

 

C. diff. Spores and More is Sponsored by:

What Is SARS-CoV-2 and the Disease It Causes Named coronavirus disease 2019 or Better Known As COVID-19

 

 

 

What is Coronavirus?

The virus has been named “SARS-CoV-2” and the disease it causes has been named “COVID-19.”

Coronaviruses are a large family of viruses that may cause respiratory illnesses in humans ranging from common colds to more severe conditions such as Severe Acute Respiratory Syndrome (SARS) and Middle Eastern Respiratory Syndrome (MERS).

‘Novel coronavirus’ is a new, previously unidentified strain of coronavirus. The novel coronavirus involved in the current outbreak has been named SARS-CoV-2 by the World Health Organization (WHO). The disease it causes has been named “coronavirus disease 2019” (or “COVID-19”).

 

LISTEN AT YOUR LEISURE

Special Episode with Dr. Teena Chopra, MD, MPH

and Jennifer Wood, C. diff. Survivor – discussing the COVID-19 and C. difficile infection information

 

How does the virus spread?

COVID-19 can spread from person to person usually through close contact with an infected person or through respiratory droplets that are dispersed into the air when an infected person coughs or sneezes.  It may also be possible to get the virus by touching a surface or object contaminated with the virus and then touching your mouth, nose or eyes, but it is not thought to be the main way the virus spreads.

 

 

Where has COVID-19 spread to?

As of the March 6, 2020, there are over 95,000 confirmed cases of infection by the virus—and 3,381 of that number have resulted in death. While most cases of COVID-19 infection are in China, the virus has spread to 88 other countries.

What are the symptoms?

Similar to other respiratory illnesses, the symptoms of COVID-19 may include fever, cough, and shortness of breath.

People infected with COVID-19 may experience any range of these symptoms along with aches and pains, nasal congestion, runny nose, sore throat and diarrhea. Symptoms can start to show up anywhere from two to 14 days after exposure to the virus3. It may be possible for an infected person who is not yet showing any symptoms to spread the virus. Older persons, and those with pre-existing medical illnesses like heart disease and diabetes, however, seem to be more likely to experience severe respiratory symptoms and complications.

How to protect yourself from coronavirus

The best preventative action is to avoid being exposed to the virus. You can do this by taking a few cautionary steps—the same as you would if you were trying to avoid getting any respiratory illness.

  1. Wash your hands with soap and water frequently. If soap and water are not readily accessible, use alcohol-based sanitizers.
  2. Avoid contact with sick people.
  3. Avoid touching your eyes, nose, and mouth with your hands if they are unwashed.
  4. Cover your mouth and nose with a tissue or your bent elbow when you sneeze or cough. Make sure to dispose of the tissue immediately.
  5. If you are feeling unwell, stay home.
  6. If you have no respiratory symptoms such cough, a medical mask is not necessary.  Only use the mask if you have symptoms such as coughing or sneezing or suspect a COVID-19 infection. A mask is recommended for those caring for anyone with COVID-19.

What to do if you suspect you are infected?

The symptoms of COVID-19 are very similar to those of a cold or the flu, making it challenging to identify the specific cause of any respiratory symptoms. If you suspect you have been infected by COVID-19, you should seek medical care as soon as possible.

Until you can access medical care, you should follow these guidelines to reduce your likelihood of infecting others:

  • Restrict your outdoor activities and stay at home as much as you can. If it is feasible, stay in a separate room, and use a different bathroom from others in your household.
  • Clean and/or disinfect objects and surfaces that you touch regularly.
  • Track your symptoms as accurately as possible, so you can provide medical personnel with useful information.

Are there any treatments or vaccines?

There are currently no treatments, drugs, or vaccines available to treat or prevent COVID-19. People infected with the virus should receive medical treatment to relieve and alleviate the symptoms they are experiencing.

For Additional Information Please Visit the CDC Website:

https://www.cdc.gov/coronavirus/2019-ncov/about/index.html

 

Resource:  https://www.gethealthystayhealthy.com/articles/what-know-about-coronavirus-covid-19-explained

What Is SARS-CoV-2 and the Disease It Causes Named coronavirus disease 2019 or Better Known As COVID-19

 

 

 

What is Coronavirus?

The virus has been named “SARS-CoV-2” and the disease it causes has been named “COVID-19.”

Coronaviruses are a large family of viruses that may cause respiratory illnesses in humans ranging from common colds to more severe conditions such as Severe Acute Respiratory Syndrome (SARS) and Middle Eastern Respiratory Syndrome (MERS).

‘Novel coronavirus’ is a new, previously unidentified strain of coronavirus. The novel coronavirus involved in the current outbreak has been named SARS-CoV-2 by the World Health Organization (WHO). The disease it causes has been named “coronavirus disease 2019” (or “COVID-19”).

 

LISTEN AT YOUR LEISURE

Special Episode with Dr. Teena Chopra, MD, MPH

and Jennifer Wood, C. diff. Survivor – discussing the COVID-19 and C. difficile infection information

 

How does the virus spread?

COVID-19 can spread from person to person usually through close contact with an infected person or through respiratory droplets that are dispersed into the air when an infected person coughs or sneezes.  It may also be possible to get the virus by touching a surface or object contaminated with the virus and then touching your mouth, nose or eyes, but it is not thought to be the main way the virus spreads.

 

 

Where has COVID-19 spread to?

As of the March 6, 2020, there are over 95,000 confirmed cases of infection by the virus—and 3,381 of that number have resulted in death. While most cases of COVID-19 infection are in China, the virus has spread to 88 other countries.

What are the symptoms?

Similar to other respiratory illnesses, the symptoms of COVID-19 may include fever, cough, and shortness of breath.

People infected with COVID-19 may experience any range of these symptoms along with aches and pains, nasal congestion, runny nose, sore throat and diarrhea. Symptoms can start to show up anywhere from two to 14 days after exposure to the virus3. It may be possible for an infected person who is not yet showing any symptoms to spread the virus. Older persons, and those with pre-existing medical illnesses like heart disease and diabetes, however, seem to be more likely to experience severe respiratory symptoms and complications.

How to protect yourself from coronavirus

The best preventative action is to avoid being exposed to the virus. You can do this by taking a few cautionary steps—the same as you would if you were trying to avoid getting any respiratory illness.

  1. Wash your hands with soap and water frequently. If soap and water are not readily accessible, use alcohol-based sanitizers.
  2. Avoid contact with sick people.
  3. Avoid touching your eyes, nose, and mouth with your hands if they are unwashed.
  4. Cover your mouth and nose with a tissue or your bent elbow when you sneeze or cough. Make sure to dispose of the tissue immediately.
  5. If you are feeling unwell, stay home.
  6. If you have no respiratory symptoms such cough, a medical mask is not necessary.  Only use the mask if you have symptoms such as coughing or sneezing or suspect a COVID-19 infection. A mask is recommended for those caring for anyone with COVID-19.

What to do if you suspect you are infected?

The symptoms of COVID-19 are very similar to those of a cold or the flu, making it challenging to identify the specific cause of any respiratory symptoms. If you suspect you have been infected by COVID-19, you should seek medical care as soon as possible.

Until you can access medical care, you should follow these guidelines to reduce your likelihood of infecting others:

  • Restrict your outdoor activities and stay at home as much as you can. If it is feasible, stay in a separate room, and use a different bathroom from others in your household.
  • Clean and/or disinfect objects and surfaces that you touch regularly.
  • Track your symptoms as accurately as possible, so you can provide medical personnel with useful information.

Are there any treatments or vaccines?

There are currently no treatments, drugs, or vaccines available to treat or prevent COVID-19. People infected with the virus should receive medical treatment to relieve and alleviate the symptoms they are experiencing.

For Additional Information Please Visit the CDC Website:

https://www.cdc.gov/coronavirus/2019-ncov/about/index.html

 

Resource:  https://www.gethealthystayhealthy.com/articles/what-know-about-coronavirus-covid-19-explained