Antibody Tests Go To Market Largely Unregulated, Warns House Subcommittee Chair
4 years, 8 months ago

Antibody Tests Go To Market Largely Unregulated, Warns House Subcommittee Chair

NPR  

Antibody Tests Go To Market Largely Unregulated, Warns House Subcommittee Chair Enlarge this image toggle caption Seth Wenig/AP Seth Wenig/AP Coronavirus antibody tests have garnered attention from officials as a potential tool to evaluate people's immunity to the illness. Krishnamoorthi said that federal officials have told his subcommittee that companies selling antibody tests can go one of two routes as they seek to bring their products to market. In lieu of mandatory FDA authorization, the majority of antibody test-makers are "self-validating," according to Krishnamoorthi. He added: "A Wild West of unregulated tests are now proliferating, and our biggest concerns are that they are unreliable, inaccurate and in many cases making fraudulent claims about their testing results."

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History of this topic

At long last, WHO issues coronavirus testing advice
2 years, 9 months ago

At long last, WHO issues coronavirus testing advice

LA Times  

A woman is tested for a coronavirus infection at the Lenasia South Hospital near Johannesburg in South Africa. The advice comes months after critics said the lack of recommendations from the global health agency was compromising efforts to stop the pandemic in poor countries. At a press briefing on Wednesday, WHO Director-General Tedros Adhanom Ghebreyesus said the agency was concerned …

Biden's new winter COVID plan will reimburse you for at-home tests
3 years, 1 month ago

Biden's new winter COVID plan will reimburse you for at-home tests

NPR  

Biden's new winter COVID plan will reimburse you for at-home tests Enlarge this image toggle caption Evan Vucci/AP Evan Vucci/AP President Biden announced Thursday that private health insurance plans will soon reimburse people who buy over-the-counter, at-home rapid tests for the coronavirus — one of a series of steps the White House is planning in order to encourage better detection …

Antibody Tests Should Not Be Your Go-To For Checking COVID Immunity
3 years, 4 months ago

Antibody Tests Should Not Be Your Go-To For Checking COVID Immunity

NPR  

Antibody Tests Should Not Be Your Go-To For Checking COVID Immunity Enlarge this image toggle caption Naveen Sharma/SOPA Images/LightRocket via Getty Naveen Sharma/SOPA Images/LightRocket via Getty Booster shots against the coronavirus have already started rolling out in the U.S. for some people and millions more could be due for them soon. Sponsor Message Unlike other COVID-19 tests that are used …

Consumers warned to check home corona tests against approved list
3 years, 8 months ago

Consumers warned to check home corona tests against approved list

Dutch News  

Health inspectors have received dozens of reports of unlicensed coronavirus test kits being sold online and over the counter in shops. In other cases tests are advertised as ‘approved by the RIVM’, even though the public health agency does not have a certification system. ‘Some shops have stopped selling the tests as a result, or make clear on their website …

Consumers warned to check home corona tests against approved list
3 years, 8 months ago

Consumers warned to check home corona tests against approved list

Dutch News  

Health inspectors have received dozens of reports of unlicensed coronavirus test kits being sold online and over the counter in shops. In other cases tests are advertised as ‘approved by the RIVM’, even though the public health agency does not have a certification system. ‘Some shops have stopped selling the tests as a result, or make clear on their website …

Millions in US have taken antibody tests - but scientists don't know what results mean
4 years, 4 months ago

Millions in US have taken antibody tests - but scientists don't know what results mean

Daily Mail  

At the height of the coronavirus lockdown, President Donald Trump and his top health advisers trumpeted a new test that would help Americans reclaim their lives - one that would tell them if they already had the virus and were protected from getting it again. It's not clear how many antibody tests have been administered nationwide - some 1.5 million …

What you need to know about coronavirus on Monday, August 31
4 years, 4 months ago

What you need to know about coronavirus on Monday, August 31

CNN  

A version of this story appeared in the August 31 edition of CNN’s Coronavirus: Fact vs. Fiction newsletter. WHAT’S IMPORTANT TODAY India becomes the world’s third deadliest Covid-19 country India reported 971 Covid-19 deaths yesterday, bringing the total to 64,469 and surpassing Mexico as the country with the third highest number of Covid-19 deaths globally, according to the latest data …

Hype and science collide as FDA tries to rein in ‘wild West’ of COVID-19 blood tests
4 years, 7 months ago

Hype and science collide as FDA tries to rein in ‘wild West’ of COVID-19 blood tests

LA Times  

“Save your business while saving lives,” reads the website of Because Health, a Seattle tech start-up selling two types of tests to employers willing to pay $350 a pop to learn whether their workers have been infected with COVID-19. The company’s “Workplace Health” plan includes not only nasal swab tests to detect infection, but also blood tests aimed at determining …

Biocon arm Syngene develops ELISA test kits, ties up with HiMedia for production
4 years, 7 months ago

Biocon arm Syngene develops ELISA test kits, ties up with HiMedia for production

Live Mint  

Syngene International Ltd has developed its own ELISA antibody testing kits at its research facility in Bengaluru and has tied up with bioscience firm HiMedia Laboratories for manufacturing and distribution of the testing kits. Biocon Ltd’s contract research arm has developed the testing kit, which it claims has a capacity to test multiple samples together in a single run and …

HALF of coronavirus antibody finger-prick tests are unreliable, study of nine finds
4 years, 7 months ago

HALF of coronavirus antibody finger-prick tests are unreliable, study of nine finds

Daily Mail  

A new investigation reveals that several antibody tests for the novel coronavirus currently on the market are unreliable. ABC News and the Mayo Clinic looked at nine tests that use a drop of a blood from a finger prick to see if someone has immune-fighting cells against the virus. Four of nine coronavirus antibody finger prick tests failed to meet …

Coronavirus: NHS and social care staff to get antibody tests from next week, Matt Hancock to announce
4 years, 7 months ago

Coronavirus: NHS and social care staff to get antibody tests from next week, Matt Hancock to announce

The Independent  

Sign up for the View from Westminster email for expert analysis straight to your inbox Get our free View from Westminster email Get our free View from Westminster email SIGN UP I would like to be emailed about offers, events and updates from The Independent. Read our privacy policy NHS and social care staff will be able to get antibody …

Getting An Antibody Test For The Coronavirus? Here's What It Won't Tell You
4 years, 7 months ago

Getting An Antibody Test For The Coronavirus? Here's What It Won't Tell You

NPR  

Getting An Antibody Test For The Coronavirus? Here's What It Won't Tell You Enlarge this image toggle caption Paul Hennessy/Echoes WIre/Barcroft Media via Getty Images Paul Hennessy/Echoes WIre/Barcroft Media via Getty Images Salvador Perez got really sick in April. Enlarge this image toggle caption Sheila Perez Sheila Perez "He's anxious that he doesn't want to get sick. Some people also …

Early trials for Covid vaccine show promise
4 years, 7 months ago

Early trials for Covid vaccine show promise

India Today  

Early-stage human trials for a coronavirus vaccine have shown encouraging signs, with the experimental shots inducing immune responses in healthy volunteers, US drugmaker Moderna announced Monday. The interim results, the Massachusetts-based biotech company said in a statement, show that the virus-fighting antibodies the vaccine labelled mRNA-1273 generated were at similar levels to people who recovered from Covid-19. “When combined with …

Coronavirus: ‘100% accurate’ antibody test approved for use in UK for first time
4 years, 7 months ago

Coronavirus: ‘100% accurate’ antibody test approved for use in UK for first time

The Independent  

Sign up for our free Health Check email to receive exclusive analysis on the week in health Get our free Health Check email Get our free Health Check email SIGN UP I would like to be emailed about offers, events and updates from The Independent. Read our privacy policy A test to check whether a person has previously had coronavirus …

Swiss drugmaker in talks with UK govt to roll out Covid antibody test kits
4 years, 7 months ago

Swiss drugmaker in talks with UK govt to roll out Covid antibody test kits

Hindustan Times  

Swiss drugmaker Roche Holding AG said on Wednesday it was in talks with the UK government to roll out its coronavirus antibody test kits in the country after Public Health England found them reliable. “This is a very positive development because such a highly specific anti-body test is a very reliable marker of past infection,” UK’s coronavirus testing programme coordinator …

Exclusive: First coronavirus antibody test given approval by Public Health England
4 years, 7 months ago

Exclusive: First coronavirus antibody test given approval by Public Health England

The Telegraph  

UPDATE: Since this article was posted, published results of PHE's evaluation of the Roche test show that although 100% of negative samples accurately came back as negative, 16% of samples taken from people who had had the virus did not show up as positive. A coronavirus antibody test kit has been approved by Public Health England, The Telegraph has learned, …

U.S. approves new coronavirus antigen test with fast results
4 years, 7 months ago

U.S. approves new coronavirus antigen test with fast results

The Hindu  

U.S. regulators have approved a new type of coronavirus test that administration officials have promoted as a key to opening up the country. The Food and Drug Administration on Saturday announced emergency authorization for antigen tests developed by Quidel Corporation of San Diego. Antigen tests can diagnose active infections by detecting the earliest toxic traces of the virus rather than …

Coronavirus: Rollout of antibody tests met with confusion, little oversight
4 years, 8 months ago

Coronavirus: Rollout of antibody tests met with confusion, little oversight

CNN  

CNN — Public health experts, including members of the White House Coronavirus Task Force, have argued accurate Covid-19 antibody tests can support efforts to get Americans back to work by determining who may have overcome the virus. States concerned by accuracy of antibody tests Antibody test data “are of dubious reliability; we are not tracking or analyzing them,” a spokesperson …

Coronavirus: UK in talks over rollout of antibody test with near-100% accuracy rate, says Hancock
4 years, 8 months ago

Coronavirus: UK in talks over rollout of antibody test with near-100% accuracy rate, says Hancock

The Independent  

Sign up for the View from Westminster email for expert analysis straight to your inbox Get our free View from Westminster email Get our free View from Westminster email SIGN UP I would like to be emailed about offers, events and updates from The Independent. Read our privacy policy The UK is in talks with pharmaceutical giant Roche on a …

Coronavirus: ‘Fast and accurate’ antibody test developed by Edinburgh researchers
4 years, 8 months ago

Coronavirus: ‘Fast and accurate’ antibody test developed by Edinburgh researchers

The Independent  

Sign up for our free Health Check email to receive exclusive analysis on the week in health Get our free Health Check email Get our free Health Check email SIGN UP I would like to be emailed about offers, events and updates from The Independent. Read our privacy policy A blood-screening company claims it has developed a “fast and accurate” …

FDA gives emergency approval to Roche's coronavirus antibody blood test
4 years, 8 months ago

FDA gives emergency approval to Roche's coronavirus antibody blood test

Daily Mail  

The US Food and Drug Administration has issued emergency use approval to Swiss drug maker Roche Holding AG for an antibody test to help determine if people have ever been infected with the coronavirus. Roche, which also makes molecular tests to identify active COVID-19 infections, said its antibody test has a specificity rate of 99.8 percent and a sensitivity rate …

FDA Cracks Down On Antibody Tests For Coronavirus
4 years, 8 months ago

FDA Cracks Down On Antibody Tests For Coronavirus

NPR  

FDA Cracks Down On Antibody Tests For Coronavirus Enlarge this image toggle caption Seth Wenig/AP Seth Wenig/AP The Food and Drug Administration is stiffening its rules to counteract what some have called a Wild West of antibody testing for the coronavirus. Sponsor Message Now the FDA is telling manufacturers that if they want their tests to remain on the market, …

A Next-Generation Coronavirus Test Raises Hopes And Concerns
4 years, 8 months ago

A Next-Generation Coronavirus Test Raises Hopes And Concerns

NPR  

A Next-Generation Coronavirus Test Raises Hopes And Concerns Enlarge this image toggle caption Sergii Iaremenko/Science Photo Library/Getty Images Sergii Iaremenko/Science Photo Library/Getty Images States clamoring for coronavirus tests in recent weeks have been talking about two types. Sponsor Message "We have to have a breakthrough innovation in testing," Dr. Deborah Birx of the White House coronavirus task force said recently …

Coronavirus antibody tests are still a work in progress
4 years, 8 months ago

Coronavirus antibody tests are still a work in progress

LA Times  

After hearing for months about serious access issues involving tests that diagnose COVID-19 based on swabs from the nose or throat, Americans are being inundated with reports about promising new tests that look for signs of coronavirus infection in the blood. “You may even miss some infected people completely.” Other tests may flag people as positive for COVID-19 when they’re …

Coronavirus antibody tests have ‘really terrible’ accuracy, researcher says
4 years, 8 months ago

Coronavirus antibody tests have ‘really terrible’ accuracy, researcher says

CNN  

CNN — Some antibody tests, which check for prior Covid-19 infection, had high rates of false positives in screenings performed by a consortium of California laboratories, according to a recently released report. Of the 12 antibody tests that were studied by the COVID-19 Testing Project, one of the tests gave false positives more than 15% of the time, or in …

Coronavirus: US report identifies most accurate antibody tests
4 years, 8 months ago

Coronavirus: US report identifies most accurate antibody tests

Daily Mail  

A new study of coronavirus antibody tests that are currently on the market revealed that at least eight out of 14 had an accuracy rate of more than 95 percent and three of those were more than 99 percent accurate, but doctors remain concerned that more work needs to be done before they can be solely relied upon to restart …

As Antibody Tests Flood The Market, House Panel Steps In
4 years, 8 months ago

As Antibody Tests Flood The Market, House Panel Steps In

NPR  

As Antibody Tests Flood The Market, House Panel Steps In Illinois Democrat Raja Krishnamoorthi, who chairs the House Oversight subcommittee on Economic and Consumer Policy, says the FDA is unable to validate the accuracy of serology tests LULU GARCIA-NAVARRO, HOST: There are two types of tests taking place right now. Now a House oversight subcommittee has raised the alarm, saying …

72 COVID-19 therapeutics trial underway, 211 in planning stages: FDA
4 years, 8 months ago

72 COVID-19 therapeutics trial underway, 211 in planning stages: FDA

India TV News  

A top Trump administration health official has said that as many as 19 therapeutics trial are underway and 211 in planning stages in a bid to find the cure for coronavirus. “Seventy-two trials of therapeutics are underway in the United States under FDA oversight and 211 are in the planning stages, so we expect to see more. “They have to …

Roche CEO Severin Schwan Calls Some Covid-19 Antibody Tests 'A Disaster'
4 years, 8 months ago

Roche CEO Severin Schwan Calls Some Covid-19 Antibody Tests 'A Disaster'

News 18  

Some blood tests being marketed to tell people if they have had the new coronavirus are a “disaster”, Roche Chief Executive Severin Schwan said on Wednesday as he prepares to launch the drugmaker’s own antibody test next month. Roche’s diagnostics business has moved out of the shadow of its main medicines unit during the pandemic, as the Swiss pharma giant …

New York Starts 'Aggressive' Coronavirus Antibody Testing In Quest To Reopen Economy
4 years, 8 months ago

New York Starts 'Aggressive' Coronavirus Antibody Testing In Quest To Reopen Economy

NPR  

New York Starts 'Aggressive' Coronavirus Antibody Testing In Quest To Reopen Economy Enlarge this image toggle caption Hannah A. Bullock, Azaibi Tamin/AP Hannah A. Bullock, Azaibi Tamin/AP New York has begun "the most aggressive" statewide antibody testing to help determine how much of the population has been infected by and recovered from the coronavirus — a step health officials say …

Coronavirus antibody tests are almost impossible to get. Meet three L.A. residents who got them
4 years, 8 months ago

Coronavirus antibody tests are almost impossible to get. Meet three L.A. residents who got them

LA Times  

Jake Warner came down with something in late February, but he wasn’t sure with what. “An imperfect test works fine in a research study because in the analysis you can sort of account for that inaccuracy, but when you’re dealing with an individual patient, you have to be right,” said Dr. Paul Simon, chief science officer for the county Department …

What we know about the state of coronavirus treatments, vaccines and antibody tests
4 years, 8 months ago

What we know about the state of coronavirus treatments, vaccines and antibody tests

CNN  

CNN — As the US begins to discuss reopening the country, health experts and officials see the development of coronavirus tests, treatments and preventative strategies as crucial to taking the first step towards normalcy. Here’s what we know about where possible coronavirus treatments, vaccines and antibody tests stand. Antibody testing Antibody tests are often cited as key to returning to …

News Brief: WHO Funding, Reopening The U.S., Antibody Tests
4 years, 8 months ago

News Brief: WHO Funding, Reopening The U.S., Antibody Tests

NPR  

News Brief: WHO Funding, Reopening The U.S., Antibody Tests U.S. ends WHO funding pending a review of its handling of COVID-19. PRESIDENT DONALD TRUMP: Had the WHO done its job to get medical experts into China to objectively assess the situation on the ground and to call out China's lack of transparency, the outbreak could have been contained at its …

The FDA authorizes 2 more coronavirus antibody tests
4 years, 8 months ago

The FDA authorizes 2 more coronavirus antibody tests

CNN  

CNN — The US Food and Drug Administration issued emergency-use authorizations Wednesday for two new coronavirus antibody tests. Still, experts say the antibody tests can be helpful in understanding how widespread coronavirus really is, since they should be able to detect past infections, even if someone had few or no symptoms. Abbott’s IgG antibody test will initially be available on …

Scientists have bad news about coronavirus antibody tests
4 years, 8 months ago

Scientists have bad news about coronavirus antibody tests

CNN  

CNN — In a phone call last week, some of the nation’s top scientists briefed White House officials about antibody testing, according to two doctors who were on the call. Dr. Deborah Birx, the coordinator of the White House coronavirus task force, has called such tests “critical.” The test can help determine if someone is immune to coronavirus, “and that’s …

Fears of ‘Wild West’ as COVID-19 blood tests hit the market
4 years, 8 months ago

Fears of ‘Wild West’ as COVID-19 blood tests hit the market

Associated Press  

WASHINGTON — Blood tests for the coronavirus could play a key role in deciding whether millions of Americans can safely return to work and school. With almost no FDA oversight of the tests, “Right now it’s a wild west show out there,” said Eric Blank of the Association for Public Health Laboratories. Last week, FDA Commissioner Stephen Hahn said in …

Fauci Says U.S. Coronavirus Deaths May Be 'More Like 60,000'; Antibody Tests On Way
4 years, 9 months ago

Fauci Says U.S. Coronavirus Deaths May Be 'More Like 60,000'; Antibody Tests On Way

NPR  

Fauci Says U.S. Coronavirus Deaths May Be 'More Like 60,000'; Antibody Tests On Way Enlarge this image toggle caption Kevin Lamarque/Reuters Kevin Lamarque/Reuters The U.S. is enduring a "very bad week" during the COVID-19 pandemic, Dr. Anthony Fauci says. The final toll currently "looks more like 60,000 than the 100,000 to 200,000" that U.S. officials previously estimated, Fauci said. Fauci, …

‘Crappy’ tests to check for past coronavirus infection are flooding the US, lab association says
4 years, 9 months ago

‘Crappy’ tests to check for past coronavirus infection are flooding the US, lab association says

CNN  

CNN — Regulatory changes by President Donald Trump’s administration have made it easier for companies to flood the US market with “crappy” tests that are supposed to determine whether someone has recovered from coronavirus, according to the CEO of the Association of Public Health Laboratories. “It’s like the wild, wild West out there – or wild East,” said Scott Becker, …

FDA authorizes first coronavirus antibody test
4 years, 9 months ago

FDA authorizes first coronavirus antibody test

CNN  

CNN — The US Food and Drug Administration has issued its first emergency use authorization for a coronavirus test that looks for antibodies in the blood. “Based on the totality of scientific evidence available to FDA, it is reasonable to believe that your product may be effective in diagnosing COVID-19,” said the agency, adding that “the known and potential benefits …

A coronavirus immunity test is essential for the U.S. But will it work?
4 years, 9 months ago

A coronavirus immunity test is essential for the U.S. But will it work?

LA Times  

It’s a potential saving grace salvaged from a pandemic: As people recover from the coronavirus, they may develop immunity that could allow them to return to school or work, helping place the U.S. on the road to recovery. The U.S., by comparison, hasn’t come up with a cohesive plan for large-scale antibody testing, which health experts say could dash chances …

Antibody tests: To get a grip on coronavirus, we need to know who's already had it
4 years, 9 months ago

Antibody tests: To get a grip on coronavirus, we need to know who's already had it

ABC  

With much of society now effectively in lockdown, how will we know when it's safe to resume something like normality? Because antibodies are specific to a particular virus, that means if we can detect SARS-CoV-2 specific antibodies in someone's blood, we know that person has already been infected with the coronavirus. Stay up-to-date on the coronavirus outbreak Download the ABC …

FACT CHECK: Trump's Accusations About The Obama Administration And Swine Flu
4 years, 9 months ago

FACT CHECK: Trump's Accusations About The Obama Administration And Swine Flu

NPR  

FACT CHECK: Trump's Accusations About The Obama Administration And Swine Flu Enlarge this image toggle caption The White House via Getty Images The White House via Getty Images Updated at 5:39 p.m. In a series of tweets Friday morning, Trump accused former President Barack Obama of making unspecified changes that "complicated" the Centers For Disease Control and Prevention's testing system. …

Trump Administration Announces Measures To Speed Coronavirus Testing
4 years, 9 months ago

Trump Administration Announces Measures To Speed Coronavirus Testing

NPR  

Trump Administration Announces Measures To Speed Coronavirus Testing Enlarge this image toggle caption Josh Edelson/AFP via Getty Images Josh Edelson/AFP via Getty Images The Trump administration has announced a series of measures intended to speed testing for the coronavirus disease COVID-19: a new federal coordinator to oversee testing, funding for two companies developing rapid tests and a hotline for labs …

Chaos at hospitals due to shortage of coronavirus testing
4 years, 10 months ago

Chaos at hospitals due to shortage of coronavirus testing

LA Times  

A researcher works in a lab that is developing a test for the coronavirus last week in Nutley, N.J. As COVID-19 cases spike, the testing needed to help stem the spread of the disease remains below what is needed to address the growing crisis, with healthcare workers across the state reporting widespread failings in the response by local and federal …

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