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Coronavirus (COVID-19) Update: FDA Authorizes First Two Tests that Estimate a Patient's Antibodies from Past SARS-CoV-2 Infection – Stockhouse

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SILVER SPRING, Md., July 31, 2020 /PRNewswire/ — Today, the U.S. Food and Drug Administration authorized the first two COVID-19 serology tests that display an estimated quantity of antibodies present in the individual’s blood. Both tests from Siemens, the ADVIA Centaur COV2G and Attelica COV2G, are what are known as “semi-quantitative” tests, meaning that they do not display a precise measurement, but estimate the quantity of a patient’s antibodies produced against infection with the virus that causes COVID-19.

“Being able to measure a patient’s relative level of antibodies in response to a previous SARS-CoV-2 infection may be useful as we continue to learn more about the virus and what the existence of antibodies may mean,” said Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “There are still many unknowns about what the presence of SARS-CoV-2 antibodies may tell us about potential immunity, but today’s authorizations give us additional tools to evaluate those antibodies as we continue to research and study this virus. Patients should not interpret results as telling them they are immune, or have any level of immunity, from the virus.”

Due to these unknowns, the FDA cautions patients against using the results from these tests, or any serology test, as an indication that they can stop taking steps to protect themselves and others, such as stopping social distancing, discontinuing wearing masks or returning to work. The FDA also wants to remind patients that serology tests should not be used to diagnose an active infection, as they only detect antibodies the immune system develops in response to the virus – not the virus itself.

Media Contact:Jim McKinney, 240-328-7305

Consumer Inquiries: 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/coronavirus-covid-19-update-fda-authorizes-first-two-tests-that-estimate-a-patients-antibodies-from-past-sars-cov-2-infection-301104199.html

SOURCE U.S. Food and Drug Administration

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Disability rights groups launching Charter challenge against MAID law

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TORONTO – A coalition of disability rights groups says it is launching a Charter challenge against a part of Canada’s law on medical assistance in dying.

The group, which also includes two individual plaintiffs, argues that what’s known as track two of the MAID law has resulted in premature deaths.

Under the law, patients whose natural deaths are not reasonably foreseeable but whose condition leads to intolerable suffering can apply for a track-two assisted death.

The coalition says track two of the MAID law has had a direct effect on the lives of people with disabilities and argues medically assisted death should only be available to those whose natural death is reasonably foreseeable.

The executive vice-president of Inclusion Canada – which is part of the coalition – says there has been an alarming trend where people with disabilities are seeking assisted death due to social deprivation, poverty and a lack of essential supports.

Krista Carr says those individuals should instead be supported in order to live better lives.

This report by The Canadian Press was first published Sept. 26, 2024.

The Canadian Press. All rights reserved.

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People with diabetes in lower-income areas at higher risk for amputations: report

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TORONTO – The Canadian Institute for Health Information says more than 7,000 people with diabetes undergo a leg, foot or toe amputation every year — and the majority of those procedures could have been prevented.

The report issued today says people with diabetes living in the lowest-income neighbourhoods are three times more likely to have an amputation than those living in the highest-income communities.

It also says people with diabetes living in remote communities are at higher risk of leg amputations than those living in urban centres.

Erin Pichora, CIHI’s program lead for population health, says lack of access to a primary-care provider to help people manage diabetes is one likely factor behind the inequalities.

She says disparities are also likely in access to specialists who can treat diabetic wounds on people’s feet — including podiatrists and chiropodists — before they worsen.

Diabetes Canada says the report shows the importance of ensuring people with diabetes have equitable access to the care and resources they need.

“People living with diabetes who undergo amputations face significant emotional and financial distress,” Laura O’Driscoll, senior manager of policy at Diabetes Canada, said in an emailed statement to The Canadian Press.

“We need to ensure that everyone with diabetes has affordable, timely access to the medications, devices, education, and care needed to manage their condition and prevent complications like amputation.”

The CIHI researchers reviewed hospital records from across Canada for fiscal years 2020-2021 and 2022-2023 and found about 7,720 “lower limb” amputations associated with diabetes per year among people 18 and older.

Each year there were about 3,080 hospitalizations for “above-ankle” leg amputations and 4,640 hospitalizations for “ankle-and-below” amputations, including feet and toes.

This report by The Canadian Press was first published Sept. 26, 2024.

Canadian Press health coverage receives support through a partnership with the Canadian Medical Association. CP is solely responsible for this content.

The Canadian Press. All rights reserved.

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“A few processes to go through”: LaGrange says more work to do on doctor pay deal

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Health Minister Adriana LaGrange says there’s more work to be done before a new compensation contract for Alberta’s doctors is finalized.

LaGrange says she has to make sure the new deal, which was agreed to in part this past April, is sustainable.

She says doctor compensation under the existing contract over the past few years has risen quicker than inflation and population growth and is currently over budget this year.

The group representing Alberta’s doctors have said the government is dragging its feet in implementing the new deal and putting patients’ lives at risk in the process.

LaGrange says while Alberta Medical Association officials are correct in saying the provincial Treasury Board still needs to approve the new contract, she’s still reviewing a pay rate assessment.

She says the government is still on track to implement the new deal this fall.

This report by The Canadian Press was first published Sept. 25, 2024.

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