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 whether workers have developed antibodies to the virus — and, possibly, future protection. As of June 1, only 15 antibody tests had received FDA “emergency-use authorizations,” which allow tests that haven’t been fully vetted to be used in a crisis. “They shouldn’t think a testing program in any way relieves them of that responsibility.” FDA officials said they’re working now with the National Cancer Institute to independently validate serology tests on the market. “FDA’s lane is to review these tests and make sure that they are safe and accurate for the American people,” said agency representative Emma Spaulding.

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History of this topic

Do at-home COVID tests still work? New research suggests they are less effective than thought
1 year, 6 months ago

Do at-home COVID tests still work? New research suggests they are less effective than thought

Salon  

Most of us have taken a COVID test at home. Reid Akana, co-author of the study, explained to Salon that one unique part of their study was that they measured the number of viral particles in various specimens, perhaps suggesting that the nose isn't the best place to test, as most at-home antigen tests were designed and approved to do. …

FDA: Take 3 home tests if exposed to COVID to boost accuracy
2 years, 4 months ago

FDA: Take 3 home tests if exposed to COVID to boost accuracy

Associated Press  

WASHINGTON — If you were exposed to COVID-19, take three home tests instead of two to make sure you’re not infected, according to new U.S. recommendations released Thursday. Previously, the Food and Drug Administration had advised taking two rapid antigen tests over two or three days to rule out infection. Thursday’s update reflects the evolving understanding of the accuracy of …

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 …

Why are rapid tests for COVID-19 in such short supply?
3 years ago

Why are rapid tests for COVID-19 in such short supply?

LA Times  

Boxes of BinaxNow home COVID-19 tests made by Abbott are shown for sale in November at a CVS store in Lakewood, Wash. Is that tickle in your nose COVID-19, or just a cold? Abbott Laboratories, which makes the BinaxNOW rapid antigen test, expects to produce 70 million tests this month and is working to raise that to 100 million, said …

Omicron scare: New rapid test identifies how antibodies fight Covid-19 variants
3 years, 1 month ago

Omicron scare: New rapid test identifies how antibodies fight Covid-19 variants

Hindustan Times  

Biomedical engineers of Duke University have developed a test to quickly and easily assess how well a person's neutralizing antibodies fight multiple variants of COVID-19 like Delta and the new Omicron variant. Researchers have developed a test to quickly assess how well a person's antibodies fight multiple variants of COVID-19. "While developing a point-of-care test for COVID-19 antibodies and biomarkers, …

HHS withdraws Trump administration policy that limited FDA review of certain Covid-19 tests
3 years, 1 month ago

HHS withdraws Trump administration policy that limited FDA review of certain Covid-19 tests

CNN  

CNN — The Biden administration is withdrawing a policy established under the Trump administration that limited the US Food and Drug Administration’s review process of certain lab tests, including some Covid-19 tests. Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a separate statement on Monday that Covid-19 testing remains a “cornerstone” of the …

Antibody tests for COVID-19 remain popular in Russia
3 years, 3 months ago

Antibody tests for COVID-19 remain popular in Russia

The Independent  

For free real time breaking news alerts sent straight to your inbox sign up to our breaking news emails Sign up to our free breaking news emails Sign up to our free breaking news emails SIGN UP I would like to be emailed about offers, events and updates from The Independent. There are different counting methods.” But Western health experts …

Russians flock to antibody tests; West notes tool’s limit
3 years, 3 months ago

Russians flock to antibody tests; West notes tool’s limit

Associated Press  

MOSCOW — When Russians talk about the coronavirus over dinner or in hair salons, the conversation often turns to “antitela,” the Russian word for antibodies — the proteins produced by the body to fight infection. There are different counting methods.” But Western health experts say the antibody tests so popular in Russia are unreliable either for diagnosing COVID-19 or assessing …

As Delta variant surges, so does demand for at-home covid-19 tests
3 years, 4 months ago

As Delta variant surges, so does demand for at-home covid-19 tests

Live Mint  

Demand for at-home Covid-19 tests has risen sharply in recent weeks as the Delta variant surges across the U.S., causing test makers to scramble to keep pace. Much of the Covid-19 diagnostic testing in the U.S. has involved not antigen tests but molecular tests, which detect the virus’s genetic material and typically are processed by laboratories—a more time-consuming process. Demand …

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 …

New Evidence Points To Antibodies As A Reliable Indicator Of Vaccine Protection
3 years, 4 months ago

New Evidence Points To Antibodies As A Reliable Indicator Of Vaccine Protection

NPR  

New Evidence Points To Antibodies As A Reliable Indicator Of Vaccine Protection Enlarge this image toggle caption Britta Pedersen/dpa/picture alliance via Getty Images Britta Pedersen/dpa/picture alliance via Getty Images When Dr. Anthony Fauci spoke recently at a White House briefing about the need for COVID-19 booster shots, buried in his slideshow of charts and data points was a little-noticed scientific …

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-19 antibodies may protect against reinfection later, study suggests
3 years, 10 months ago

Covid-19 antibodies may protect against reinfection later, study suggests

CNN  

CNN — There’s new evidence that connects testing positive for Covid-19 antibodies from a prior infection with a significantly lower risk of becoming infected again in the future. A study, published in the journal JAMA Internal Medicine on Wednesday, found that people who tested positive for Covid-19 antibodies were at a decreased risk of coronavirus infection compared with those who …

A year into the pandemic, where are all the fast, easy home tests?
3 years, 11 months ago

A year into the pandemic, where are all the fast, easy home tests?

CNN  

CNN — Last March former President Donald Trump said “anybody that wants a test can get a test” for Covid-19. “Almost all the infections happen from people who don’t know that they’re positive, and so what you need is a widespread testing program that helps people identify when they are infectious so they can stop infecting other people,” said Dr. …

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 …

Studies find having COVID-19 may protect against reinfection
4 years ago

Studies find having COVID-19 may protect against reinfection

The Independent  

For free real time breaking news alerts sent straight to your inbox sign up to our breaking news emails Sign up to our free breaking news emails 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. on the order of the …

U.S. FDA grants emergency use authorization to...
4 years, 1 month ago

U.S. FDA grants emergency use authorization to...

Daily Mail  

The FDA on Saturday issued emergency use authorization for Regeneron Pharmaceuticals Inc's COVID-19 antibody therapy, an experimental treatment given to President Donald Trump that he said helped cure him of the disease. The FDA said the monoclonal antibodies, casirivimab and imdevimab, should be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients with positive …

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 vaccine: Australian vaccine safe, produces antibody response in early tests
4 years, 1 month ago

Coronavirus vaccine: Australian vaccine safe, produces antibody response in early tests

Live Mint  

Developed by an Australian university and CSL Ltd, an early testing of a potential coronavirus vaccine has shown it to be safe and produce an antibody response, Minister for Health Greg Hunt told news agency Reuters on Friday. Covid-19 vaccine update Earlier this week, Pfizer said that its experimental coronavirus vaccine had been more than 90% effective based on initial …

Australian coronavirus vaccine 'safe', produces antibody response in early tests
4 years, 1 month ago

Australian coronavirus vaccine 'safe', produces antibody response in early tests

India Today  

Early testing of a potential COVID-19 vaccine developed by an Australian university and CSL Ltd has shown it to be safe and produce an antibody response, Minister for Health Greg Hunt said on Friday. Several candidates including ones produced Pfizer Inc and AstraZeneca are expected to imminently announce the results from last stage testing. While slightly behind other candidates, the …

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 …

Testing timeline: What is ahead for COVID-19 vaccines
4 years, 1 month ago

Testing timeline: What is ahead for COVID-19 vaccines

Live Mint  

Pfizer's surprising news that its COVID-19 vaccine might offer more protection than anticipated — an announcement right after a fraught US presidential election campaign — is raising questions about exactly how the different shots will make it to market. Late on Monday in a series of tweets President Donald Trump accused the US Food and Drug Administration and Pfizer of …

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 …

Lilly antibody drug fails in a COVID-19 study; others go on
4 years, 2 months ago

Lilly antibody drug fails in a COVID-19 study; others go on

The Hindu  

U.S. government officials are putting an early end to a study testing an Eli Lilly antibody drug for people hospitalised with COVID-19 because it doesn’t seem to be helping them. President Donald Trump received a similar experimental, two-antibody drug from Regeneron Pharmaceuticals Inc. on an emergency basis when he was sickened with the coronavirus earlier this month. In a statement …

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 …

FDA expected to announce rigorous standards for potential coronavirus vaccines, which will likely prevent approval by election day
4 years, 3 months ago

FDA expected to announce rigorous standards for potential coronavirus vaccines, which will likely prevent approval by election day

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. President Donald Trump claimed at a …

How drugmakers can keep their pledge and still deliver an October vaccine surprise
4 years, 3 months ago

How drugmakers can keep their pledge and still deliver an October vaccine surprise

India Today  

As questions mount over whether the United States will authorize a coronavirus vaccine ahead of November elections, experts say there is a slim chance that enough evidence will be available to prove one is safe and effective in that time frame. US President Donald Trump has repeatedly said a vaccine is possible before the Nov. 3 election, and accused a …

US, European Covid-19 vaccine developers pledge to uphold testing rigour
4 years, 4 months ago

US, European Covid-19 vaccine developers pledge to uphold testing rigour

India Today  

Nine leading U.S. and European vaccine developers pledged on Tuesday to uphold the scientific standards their experimental immunisations will be held against in the global race to contain the coronavirus pandemic. The companies said in a statement they would "uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 …

Coronavirus | Oxford vaccine trial put on hold over safety concern
4 years, 4 months ago

Coronavirus | Oxford vaccine trial put on hold over safety concern

The Hindu  

AstraZeneca Plc has put a hold on the late-stage trial of its highly-anticipated COVID-19 vaccine candidate after a suspected serious adverse reaction in a study participant, health news website Stat News reported on Tuesday. The study is testing a COVID-19 vaccine being developed by AstraZeneca and University of Oxford researchers at sites including India, the United States and the United …

Russian covid-19 vaccine: Scientists cast doubt on results
4 years, 4 months ago

Russian covid-19 vaccine: Scientists cast doubt on results

Live Mint  

A group of international scientists questioned results from a study of Russia’s fast-moving coronavirus vaccine that were published in the Lancet medical journal, saying some of the findings appeared improbable. This and other patterns in the data present “several different points of concern,” according to an open letter written by Temple University professor Enrico Bucci and signed by more than …

Companies testing vaccines pledge safety, high standards
4 years, 4 months ago

Companies testing vaccines pledge safety, high standards

Associated Press  

The top executives of nine drugmakers likely to produce the first vaccines against the new coronavirus signed an unprecedented pledge meant to boost public confidence in any approved vaccines. The companies said they will seek approval or authorization for emergency use only after they have confirmed the vaccines work and are safe through a large, final round of human testing. …

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 …

Coronavirus Vaccine Trials Continue Along With Skepticism From Americans : Consider This from NPR : NPR
4 years, 4 months ago

Coronavirus Vaccine Trials Continue Along With Skepticism From Americans : Consider This from NPR : NPR

NPR  

Why Are So Many Americans Hesitant To Get A COVID-19 Vaccine? Enlarge this image toggle caption Joe Raedle/Getty Images Joe Raedle/Getty Images As trials continue for a coronavirus vaccine, some of the world's biggest drug companies have come together in an unusual way. This week, nine drugmakers released a joint statement pledging to not submit a coronavirus vaccine to the …

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 …

Trump administration says FDA will no longer require premarket review of certain lab tests, including some Covid-19 tests
4 years, 4 months ago

Trump administration says FDA will no longer require premarket review of certain lab tests, including some Covid-19 tests

CNN  

CNN — The Trump administration has determined that the US Food and Drug Administration will no longer review certain laboratory tests, including those used to detect Covid-19, according to an announcement from the US Department of Health and Human Services on Thursday. The announcement – which one expert said was part of a “bureaucratic fight” between HHS and FDA – …

US Coronavirus: FDA won’t ‘cut corners’ to approve a Covid-19 vaccine, commissioner says
4 years, 4 months ago

US Coronavirus: FDA won’t ‘cut corners’ to approve a Covid-19 vaccine, commissioner says

CNN  

CNN — Safety will not be compromised for a Covid-19 vaccine, the US Food and Drug Administration commissioner said Monday. Dr. Peter Hotez, a vaccinologist at Baylor College of Medicine, reviewed the data and also said “there’s just no way” a vaccine will be publicly available by November 3. “It’s not fair to say that this virus is completely benign …

COVID-19 vaccine candidates with early human-trial data
4 years, 6 months ago

COVID-19 vaccine candidates with early human-trial data

Live Mint  

A COVID-19 vaccine developed by German biotech firm BioNTech and US pharmaceutical giant Pfizer has shown potential and was found to be well tolerated in early-stage human trials, the companies said on Wednesday. The following rivals have released early-stage trial data for potential COVID-19 vaccines, or are expected to publish soon: Moderna Moderna Inc said in May that its vaccine …

Amsterdam researchers discover "potent" Covid-19 antibodies
4 years, 6 months ago

Amsterdam researchers discover "potent" Covid-19 antibodies

NL Times  

Researchers at Amsterdam University Medical Center discovered two proteins that are a promising possible treatment for the coronavirus, the university hospital announced. The antibodies were found in the blood of two Amsterdam patients who recovered from Covid-19 and are much more potent than antibodies found in patients who recovered from coronaviruses in the past, like SARS in 2013, according to …

First US human trials start on an antibody cocktail that may treat, and even prevent, Covid-19
4 years, 6 months ago

First US human trials start on an antibody cocktail that may treat, and even prevent, Covid-19

CNN  

CNN — A medicine that may treat and prevent Covid-19 is now being tested in patients in multiple sites around the United States, according to an announcement Thursday from Regeneron Pharmaceuticals Inc. Regeneron said its antibody cocktail will be tested in four separate study populations: people who are hospitalized with Covid-19; people who have symptoms for the disease, but are …

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 …

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. …

Moderna: Early coronavirus vaccine results are encouraging
4 years, 7 months ago

Moderna: Early coronavirus vaccine results are encouraging

Associated Press  

An experimental vaccine against the coronavirus showed encouraging results in very early testing, triggering hoped-for immune responses in eight healthy, middle-aged volunteers, its maker announced Monday. Study volunteers given either a low or medium dose of the vaccine by Cambridge, Massachusetts-based Moderna Inc. had antibodies similar to those seen in people who have recovered from COVID-19. U.S. government officials have …

WHO backs COVID-19 vaccine trials that deliberately infect participants
4 years, 7 months ago

WHO backs COVID-19 vaccine trials that deliberately infect participants

The Hindu  

In new guidelines issued on May 6, the World Health Organization has said that well-designed human challenge studies could not only accelerate coronavirus vaccine development but also make it more likely that the vaccines ultimately deployed will be far more effective. Around 30 Indian attempts at COVID-19 vaccine, says Principal Scientific Adviser In human challenge studies, healthy participants are first …

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 …

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