‘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, a reference to the fact that at least half of the companies making these tests are in China. FDA relaxes test approval rules Last month, as a result of the pandemic, the FDA changed its regulations to make it easier for companies to sell coronavirus antibody tests. “For example, a negative result from a nonapproved testing kit may lead an individual who in fact has Covid-19 to think they are healthy and not capable of spreading the virus.” FDA spokeswoman Stephanie Caccomo referred CNN to an agency statement that talked about policy changes made “in order to achieve more rapid testing capacity in the US.” The US Centers for Disease Control and Prevention is working on its own antibody test, according to agency spokeswoman Kristen Nordlund, but it is not available to the public.

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History of this topic

US FDA warns against use of certain unapproved Covid tests
2 years, 10 months ago

US FDA warns against use of certain unapproved Covid tests

Live Mint  

The US Food and Drug Administration has warned people against the use of unauthorised versions of certain Covid-19 rapid antigen tests currently being marketed in the United States. The US drug agency said that fraudulent Covid-19 products can come in many varieties, including dietary supplements and other foods, as well as products claiming to be tests, drugs, medical devices, or …

Stricter surveillance is needed for commercial coronavirus test providers, advisors say
3 years, 4 months ago

Stricter surveillance is needed for commercial coronavirus test providers, advisors say

NL Times  

The Cabinet needs to place more attention on how commercial coronavirus test providers handle the data of their clients, a commission advised the Ministry of Health. Some test pest providers keep the negative test results of patients longer than the permitted four weeks, the commission said. The risk that commercial testing providers violate their clients' privacy increased due to the …

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 …

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 …

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 …

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. …

9 Companies Pledge Not To Submit Coronavirus Vaccine To FDA Until It's Proved Safe
4 years, 4 months ago

9 Companies Pledge Not To Submit Coronavirus Vaccine To FDA Until It's Proved Safe

NPR  

9 Companies Pledge Not To Submit Coronavirus Vaccine To FDA Until It's Proved Safe To reassure the public, nine companies issued a joint statement Tuesday saying they won't seek government approval for their coronavirus vaccines until full safety and effectiveness data are in hand. SYDNEY LUPKIN, BYLINE: Drugmakers are pledging not to submit their vaccines for FDA review unless large …

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 …

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 …

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 …

Top Trump Trade Adviser Bashes CDC: 'Really Let The Country Down' On Virus Testing
4 years, 7 months ago

Top Trump Trade Adviser Bashes CDC: 'Really Let The Country Down' On Virus Testing

Huff Post  

LOADING ERROR LOADING Pete Navarro, President Donald Trump’s top trade adviser, knocked the Centers for Disease Control and Prevention on Sunday over its response to the coronavirus crisis, blaming the federal public health agency for the country’s slow rollout of tests. Asked during an appearance on NBC’s “Meet the Press” whether Trump has confidence in the CDC to lead during …

FDA suspends Gates-backed at-home coronavirus testing program
4 years, 7 months ago

FDA suspends Gates-backed at-home coronavirus testing program

Daily Mail  

An at-home coronavirus testing project backed in part by the Bill and Melinda Gates Foundation has been suspended by the US Food and Drug Administration. The Seattle Coronavirus Assessment Network was offering at-home testing kits to residents in the region, but has been ordered to discontinue indefinitely until it gets additional FDA-approval. SCAN was sharing test results with patients, but …

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 …

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 …

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 …

Coronavirus | ICMR says no payment made for Chinese test kits supplies
4 years, 8 months ago

Coronavirus | ICMR says no payment made for Chinese test kits supplies

The Hindu  

India does not stand to lose a single rupee, said the Indian Council of Medical Research on Monday in response to a clarification sought on the alleged profiteering by distributors, exposed through a legal dispute between an importer and a distributor, in the delivery COVID-19 rapid antibody testing kits to it. The matter came to light when Rare Metabolics Life …

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 …

How coronavirus testing fumbles squandered valuable time
4 years, 8 months ago

How coronavirus testing fumbles squandered valuable time

CNN  

CNN — As coronavirus test kits were malfunctioning in public health labs across the country, Dr. Robert Redfield repeatedly assured his fellow task force officials in February that the problem would be quickly solved. Any insinuation that he didn’t is “just plain wrong and disproven by the facts.” A CDC spokesman said Redfield did not offer any assurances about how …

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 …

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 …

Los Angeles Authorities Sue Company For 'Illegally Selling' At-Home COVID-19 Test
4 years, 9 months ago

Los Angeles Authorities Sue Company For 'Illegally Selling' At-Home COVID-19 Test

NPR  

Los Angeles Authorities Sue Company For 'Illegally Selling' At-Home COVID-19 Test Enlarge this image toggle caption Christopher Weber/AP Christopher Weber/AP Mike Feuer, the city attorney of Los Angeles, announced on Monday that his office had "filed a civil law enforcement action against, and achieved an immediate settlement with," a company that had been "illegally selling" an at-home test for the …

April 3, 2020 coronavirus news
4 years, 9 months ago

April 3, 2020 coronavirus news

CNN  

Alex Brandon/AP President Donald Trump and Vice President Mike Pence both stumbled over medical details, and spread inaccurate information, while touting new coronavirus tests and potential treatments. Trump mentioned anti-malaria drugs that are being tested as potential treatments, saying that the clinical trials are “having some good results,” even though public health officials say the results are months away. Moments …

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 …

March 27, 2020 coronavirus news
4 years, 9 months ago

March 27, 2020 coronavirus news

CNN  

Federal health officials on Friday green-lit a point-of-care coronavirus test that can provide results in less than 15 minutes, using the same technology that powers some rapid flu tests. Teased by Vice President Mike Pence in a Thursday press briefing, the new diagnostic could accelerate testing in the United States, allowing for rapid results in doctors’ offices. All FDA-authorized tests, …

March 27, 2020 coronavirus news
4 years, 9 months ago

March 27, 2020 coronavirus news

CNN  

Federal health officials on Friday green-lit a point-of-care coronavirus test that can provide results in less than 15 minutes, using the same technology that powers some rapid flu tests. Teased by Vice President Mike Pence in a Thursday press briefing, the new diagnostic could accelerate testing in the United States, allowing for rapid results in doctors’ offices. All FDA-authorized tests, …

Testing blunders crippled US response as coronavirus...
4 years, 9 months ago

Testing blunders crippled US response as coronavirus...

Daily Mail  

A series of missteps at the nation's top public health agency caused a critical shortage of tests for coronavirus, hobbling the federal response as the pandemic spread across the country like wildfire, an Associated Press review found. In February, as the virus began taking root in the US population, CDC data shows government labs processed 352 COVID-19 tests - an …

Coronavirus testing: US approves rapid test that can detect in 45 minutes
4 years, 9 months ago

Coronavirus testing: US approves rapid test that can detect in 45 minutes

Live Mint  

The U.S. Food and Drug Administration has approved the first rapid coronavirus diagnostic test, with a detection time of about 45 minutes, as the United States struggles to meet the demand for coronavirus testing. The test's developer, California-based molecular diagnostics company Cepheid, said on Saturday it had received an emergency use authorization from the FDA for the test, which will …

Here’s why the US is behind in coronavirus testing
4 years, 9 months ago

Here’s why the US is behind in coronavirus testing

CNN  

CNN — As the US has lagged behind other advanced nations in testing for the coronavirus, former government officials and public health experts point to a series of policy and procedural decisions that they say hindered the nation’s response to the pandemic. Asked Friday whether the US can currently meet demand for tests, Dr. Anthony Fauci, director of National Institute …

Coronavirus testing: WHO and CDC never discussed providing test kits to the US, global health agency says
4 years, 9 months ago

Coronavirus testing: WHO and CDC never discussed providing test kits to the US, global health agency says

CNN  

CNN — As the United States struggled to launch testing for the novel coronavirus using kits developed by the US Centers for Disease Control and Prevention, the World Health Organization shipped hundreds of thousands of tests to countries around the world. US officials face questions about WHO test During CNN’s coronavirus town hall last week, CNN Chief Medical Correspondent Dr. …

Coronavirus | 51 private labs will soon be allowed to conduct tests
4 years, 9 months ago

Coronavirus | 51 private labs will soon be allowed to conduct tests

The Hindu  

The “test, test, test” prescription of the World Health Organisation is not for India, Director-General of the Indian Council of Medical Research Balram Bhargava said on Tuesday, stressing that community transmission of COVID-19 has not yet occurred. Dr. Bhargava, however, also announced that 51 private laboratories will soon be allowed to test for COVID-19 to enhance capacity for diagnosis and …

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 …

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