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, they must meet minimum quality standards and submit a request for emergency use authorization, a temporary route to market for unapproved products when others aren't available. That "would dramatically increase the accuracy of those tests," said Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health Sponsor Message Antibodies are a potentially valuable research tool, and can be used to determine the prevalence of a disease in a population. New York State used antibody tests to determine that about 20 percent of people in New York City have already been exposed to the coronavirus.

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History of this topic

If exposed to the coronavirus, take 3 home tests to boost accuracy, FDA now says
2 years, 4 months ago

If exposed to the coronavirus, take 3 home tests to boost accuracy, FDA now says

LA Times  

Boxes of rapid coronavirus tests are displayed for sale at a drugstore. People screening themselves at home should use three tests to more accurately detect the virus, according to new FDA recommendations. If you were exposed to the coronavirus, take three home tests instead of two to make sure you’re not infected, according to new U.S. recommendations released Thursday. But …

Posts mislead on PCR test development
2 years, 10 months ago

Posts mislead on PCR test development

Associated Press  

CLAIM: COVID-19 PCR tests weren’t developed using samples of the coronavirus and instead detect “something else.” AP’S ASSESSMENT: Partly false. THE FACTS: Misleading posts circulating widely online in recent days are using technical documents from one COVID-19 PCR test to falsely claim that such tests don’t actually detect the coronavirus – with some users going so far as to suggest …

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 …

CDC encourages use of new tests that detect both COVID-19 and the flu
3 years, 5 months ago

CDC encourages use of new tests that detect both COVID-19 and the flu

Associated Press  

CLAIM: The Centers for Disease Control and Prevention revoked Emergency Use Authorization for coronavirus PCR tests because they were inaccurate, led to false positives and confused positive influenza cases with COVID-19. Early in the pandemic, in February 2020, the CDC introduced a COVID-19 PCR test, known as the “CDC 2019-Novel Coronavirus Real-Time RT-PCR Diagnostic Panel.” Some newer coronavirus tests can …

Early CDC Coronavirus Test Came With Inconsistent Instructions And Cost The U.S. Weeks
3 years, 7 months ago

Early CDC Coronavirus Test Came With Inconsistent Instructions And Cost The U.S. Weeks

NPR  

Early CDC Coronavirus Test Came With Inconsistent Instructions And Cost The U.S. Weeks Enlarge this image toggle caption Jessica McGowan/Getty Images Jessica McGowan/Getty Images A flawed coronavirus test distributed by government scientists early in the pandemic was poorly designed and came with erroneous instructions that made it doubly difficult for labs to rely on the test's results, new records show. …

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 …

Covid US: FDA authorizes at-home test that can give results in 10 MINUTES
3 years, 10 months ago

Covid US: FDA authorizes at-home test that can give results in 10 MINUTES

Daily Mail  

The U.S. Food and Drug Administration has authorized another at-home coronavirus test for emergency use authorization. The announcement of the approval is another important, albeit small, step to increase the number of testing options available in the U.S. Quidel Corp's at-home coronavirus test received emergency use authorization from the FDA on Monday, but it does required a prescription Users collected …

Immunity induced by COVID-19 vaccine expected to protect against new variants: Moderna
4 years ago

Immunity induced by COVID-19 vaccine expected to protect against new variants: Moderna

India TV News  

Moderna Inc on Wednesday said that it expects that the immunity induced by its COVID-19 vaccine would be protective against the new coronavirus variants found in the United Kingdom. A press release issued by the vaccine company reads, "While we plan to run tests to confirm the activity of the vaccine against any strain, the broad range of potential neutralizing …

Coronavirus was circulating in Italy earlier than thought, say researchers
4 years, 1 month ago

Coronavirus was circulating in Italy earlier than thought, say researchers

Live Mint  

The new coronavirus was circulating in Italy in September 2019, a study by the National Cancer Institute of the Italian city of Milan shows, signaling that it might have spread beyond China earlier than thought. The World Health Organization has said the new coronavirus and COVID-19, the respiratory disease it causes, were unknown before the outbreak was reported in Wuhan, …

Coronavirus: US 'not ready for antibody drugs', say Harvard doctors
4 years, 1 month ago

Coronavirus: US 'not ready for antibody drugs', say Harvard doctors

Daily Mail  

Two doctors are expressing their concerns about the Trump administration's plans to quickly roll out coronavirus antibody treatments. It comes just two days after the US Food and Drug Administration approved Eli Lilly's monoclonal antibody treatment for emergency use authorization on Monday, with plans to roll it out as early as this week. Two Harvard doctors wrote an editorial expressing …

Coronavirus Australia live news: Victoria announces free kinder for 2021, SA to decide on border this Friday
4 years, 1 month ago

Coronavirus Australia live news: Victoria announces free kinder for 2021, SA to decide on border this Friday

ABC  

This antibody drug is not the same one that was given to US President Donald Trump when he caught coronavirus, but it is a very similar treatment. The Food and Drug Administration granted emergency use authorisation to Eli Lilly & Co's bamlanivimab based on trial data showing that a one-time infusion of the treatment reduced the need for hospitalisation or …

Covid: US halts study into promising antibody treatment
4 years, 2 months ago

Covid: US halts study into promising antibody treatment

The Independent  

The latest headlines from our reporters across the US sent straight to your inbox each weekday Your briefing on the latest headlines from across the US Please enter a valid email address Please enter a valid email address SIGN UP I would like to be emailed about offers, events and updates from The Independent. Please try again later {{ /verifyErrors …

Coronavirus | Repurposed drugs did not cut down mortality, says WHO
4 years, 2 months ago

Coronavirus | Repurposed drugs did not cut down mortality, says WHO

The Hindu  

Interim results from the Solidarity Therapeutics Trial, coordinated by the World Health Organization, have indicated that remdesivir, hydroxychloroquine, lopinavir/ritonavir and interferon regimens appeared to have little or no effect on 28-day mortality or the in-hospital course of COVID-19 among hospitalised patients as per information released by the World Health Organisation. Speaking exclusively to The Hindu, about the outcome Prof. K …

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 …

Blood samples taken from New Yorkers reveal some had coronavirus antibodies in February
4 years, 6 months ago

Blood samples taken from New Yorkers reveal some had coronavirus antibodies in February

Daily Mail  

Blood samples taken from New Yorkers reveal some antibodies against the novel coronavirus much earlier than previously believed, a study suggests. Coronavirus antibodies were detected in about 2.3% of samples for the week ending on February 23, with 1.4% in one group and 0.9% in another group This means the virus was likely circulating in New York as early as …

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 …

Study shows 10 times more New Yorkers had Covid-19 by April than previously counted
4 years, 7 months ago

Study shows 10 times more New Yorkers had Covid-19 by April than previously counted

CNN  

CNN — By the end of March, 1 in 7 New York adults had Covid-19 – about 10 times higher than the official account, according to a new study This adds to a growing body of evidence that the virus was much more prevalent early on in the outbreak than health officials thought at the time. “Now is the time …

Antibody tests for Covid-19 wrong half the time, CDC says
4 years, 7 months ago

Antibody tests for Covid-19 wrong half the time, CDC says

CNN  

CNN — Antibody tests used to determine if people have been infected in the past with Covid-19 might be wrong up to half the time, the US Centers for Disease Control and Prevention said in new guidance posted on its website. “Serologic test results should not be used to make decisions about returning persons to the workplace.” Health officials or …

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 …

Coronavirus in the US: At least 4 states combined numbers from two tests
4 years, 7 months ago

Coronavirus in the US: At least 4 states combined numbers from two tests

CNN  

CNN — At least four states combined data from two different test results, potentially providing a misleading picture of when and where coronavirus spread as the nation eases restrictions. In Georgia, health officials said they’ve been adding antibody tests to their “total tests” number in line with methodology from the Centers for Disease Control and Prevention. Mayor considering a shelter-in-place …

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 …

States accused of fudging or bungling COVID-19 testing data
4 years, 7 months ago

States accused of fudging or bungling COVID-19 testing data

Associated Press  

PROVIDENCE, R.I. — Public health officials in some states are accused of bungling coronavirus infection statistics or even using a little sleight of hand to deliberately make things look better than they are. Georgia’s Department of Public Health also regularly publishes a graph that shows cases over time, except new infections are not listed on the day they came back …

A Double-Barreled Approach To Antibody Testing Could Improve Accuracy
4 years, 7 months ago

A Double-Barreled Approach To Antibody Testing Could Improve Accuracy

NPR  

A Double-Barreled Approach To Antibody Testing Could Improve Accuracy Enlarge this image toggle caption Joe Raedle/Getty Images Joe Raedle/Getty Images Last month the White House issued guidelines suggesting a way to reduce the number of false positive results in antibody tests: Run two tests. Dr. Alex Marson at UCSF says they may be able to take the data they've already …

Coronavirus US: USC study says 185k in LA have antibodies
4 years, 7 months ago

Coronavirus US: USC study says 185k in LA have antibodies

Daily Mail  

Researchers from the University of Southern California have revised their study of how many people in Los Angeles County have coronavirus antibodies - but say it's still much higher than previously believed. SCROLL DOWN FOR VIDEO A revised coronavirus antibody study from USC suggests 4.65% of Los Angeles County residents contracted the virus, which is 23 times more than reported. …

Coronavirus news you might have missed overnight: ‘Game-changer’ antibody test subject to scrutiny as eleventh hour London Tube rescue deal to cause fare hike
4 years, 7 months ago

Coronavirus news you might have missed overnight: ‘Game-changer’ antibody test subject to scrutiny as eleventh hour London Tube rescue deal to cause fare hike

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. Last week, a new antibody test developed by Swiss pharmaceutical firm Roche, touted by the …

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 …

Everything We Know About Covid-19 Antibody Tests (So Far)
4 years, 8 months ago

Everything We Know About Covid-19 Antibody Tests (So Far)

Wired  

Antibody tests are big news right now. Many people consider these blood tests key to "reopening the economy" and easing back on social distancing, sending us back to work and to some semblance of a normal social life again. The problem is that, despite the rush to make them quickly available in huge numbers to people in all places, it’s …

The Latest on Testing: Dr. Sanjay Gupta’s coronavirus podcast for May 5
4 years, 8 months ago

The Latest on Testing: Dr. Sanjay Gupta’s coronavirus podcast for May 5

CNN  

CNN — We’ve addressed early questions about testing for Covid-19, but plenty remain. Kevin de León, senior fellow at University of Southern California’s Schwarzenegger Institute for State and Global Policy: The promise of the immunology test to find out if we have the antibodies is huge. Here’s the problem: A reliable antigen test for the coronavirus isn’t yet available in …

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 …

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 …

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 …

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 …

Rapid failures: The Hindu Editorial on antibody testing kits
4 years, 8 months ago

Rapid failures: The Hindu Editorial on antibody testing kits

The Hindu  

Rapid testing kits that State governments have been using to detect antibodies to the novel coronavirus have proved unreliable, making the shift to normal life after the lockdown ends on May 3 more difficult. While the diagnostic RT-PCR test to confirm the presence of the virus using a nasal swab in a laboratory setting is considered reliable, attempts to design …

Coronavirus Has Infected A 5th Of New York City, Testing Suggests
4 years, 8 months ago

Coronavirus Has Infected A 5th Of New York City, Testing Suggests

NPR  

Coronavirus Has Infected A 5th Of New York City, Testing Suggests Enlarge this image toggle caption Johannes Eisele/AFP via Getty Images Johannes Eisele/AFP via Getty Images It was already clear that the coronavirus has the capacity to spread at an alarming rate — that, of course, is why states across the country implemented sweeping measures to slow the rate at …

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 …

Coronavirus death toll in New York falls below 500 mark for first time in 3 weeks
4 years, 8 months ago

Coronavirus death toll in New York falls below 500 mark for first time in 3 weeks

India TV News  

New York reported less than 500 deaths in a single day from the coronavirus for the first time in nearly three weeks, Governor Andrew Cuomo said on Monday, stressing that continuous drop in hospitalizations suggest that the state is descending from the “plateau” of COVID-19 infections. Cuomo said that another 478 people had died in New York on April 19, …

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