Category: Covid-19

Date Issued: August 11, 2022

The U.S. Food and Drug Administration (FDA) is advising people to perform repeat, or serial, testing following a negative result on any at-home COVID-19 antigen test, to reduce the risk an infection may be missed (false negative result) and to help prevent people from unknowingly spreading the SARS-CoV-2 virus to others. The FDA recommends repeat testing following a negative result whether or not you have COVID-19 symptoms.

At-home COVID-19 antigen tests detect proteins, called antigens, from the SARS-CoV-2, the virus that causes COVID-19. At-home COVID-19 antigen tests are less likely to detect the SARS-CoV-2 virus than molecular tests, such as polymerase chain reaction (PCR) tests. This is especially true early in an infection or in people who do not have COVID-19 symptoms. Currently, all at-home COVID-19 antigen tests are FDA-authorized for repeat, or serial use. This means people should use multiple tests over a certain time period, such as 2-3 days, especially when the people using the tests don't have COVID-19 symptoms. Today, the FDA is highlighting the continued need for repeat, or serial testing when people get a negative result with an at-home COVID-19 antigen test, including recommending additional testing over a longer period of time..

Over the course of the COVID-19 pandemic, public health scientists have continued to learn about the SARS-CoV-2 virus and the impact of variants on diagnostic tests that detect SARS-CoV-2. Today's recommendations are based on the latest study results from people with likely omicron infection showing that repeat testing after a negative at-home COVID-19 antigen test result increases the chance of an accurate result. COVID-19 diagnostic testing remains a cornerstone of our nation's fight against COVID-19. At-home COVID-19 antigen tests, while not perfect, provide a fast and convenient COVID-19 testing option.

Follow the test's step by step instructions exactly to perform the test and to read the test's results.

COVID-19 diagnostic tests detect the SARS-CoV-2 virus. At-home COVID-19 diagnostic tests are FDA-authorized for self-testing at home, or anywhere. The FDA has authorized both molecular and antigen COVID-19 diagnostic tests for home use.

Most at-home COVID-19 tests are antigen tests and do not detect the SARS-CoV-2 virus as well as molecular tests, most of which are laboratory-based such as polymerase chain reaction (PCR) tests. Molecular COVID-19 tests are generally expected to detect the SARS-CoV-2 virus at least 95% of the time when someone is infected. However, at-home COVID-19 antigen tests are generally expected to detect the SARS-CoV-2 virus at least 80% of the time when someone is infected.

When you perform an at-home COVID-19 antigen test, and you get a positive result, the results are typically accurate. However, if you perform an at-home COVID-19 antigen test, you could get a false negative result. This means that the test may not detect the SARS-CoV-2 virus that is in your nasal swab sample. This could happen if you test soon after you get an infection, especially if you don't have COVID-19 symptoms. If you receive a false negative test result, you may unknowingly spread the SARS-CoV-2 virus to others.

When at-home COVID-19 antigen tests were initially FDA-authorized, the FDA knew that for people to get accurate results, test instructions would need to include directions for repeat, or serial, testing. The FDA believed the best way to better understand COVID-19 infections and evaluate test accuracy was to require test developers to perform follow up studies with their tests. The studies would need to assess how well COVID-19 antigen tests could detect the SARS-CoV-2 virus, especially in people without COVID-19 symptoms. Therefore, the FDA required each at-home COVID-19 antigen test manufacturer to assess how well their test works when used by people with and without COVID-19 symptoms following repeat testing instructions.

In parallel, the FDA collaborated with the National Institutes for Health (NIH) and the University of Massachusetts Chan Medical School and together they designed a comprehensive study to assess at-home COVID-19 antigen test performance. The study was funded by the NIH's Rapid Acceleration Diagnostics (RADx) Program and included more than 7,000 participants. The results of the study would be available as a resource to all at-home COVID-19 antigen test manufacturers.

The study participants collected their nasal sample and performed an at-home COVID-19 antigen test. Participants who got a negative test result performed repeat testing every 48 hours, over 14 days. All participants also collected their nasal sample using a home collection kit and then sent the sample to clinical laboratory for testing with an FDA-authorized molecular test. The study compared the performance of at-home COVID-19 antigen tests to performance of a laboratory-based molecular test. Results from this study show that repeat testing over a longer timeframe improves test performance and increases the likelihood that an at-home COVID-19 antigen test will detect an infection. These results have further guided the FDA's thinking thatrepeat testing after a negative result with an at-home COVID-19 antigen test reduces the risk of a false negative result.

The FDA is committed to appropriately accurate and reliable at-home COVID-19 diagnostic tests for all Americans and will keep the public informed if significant new information about COVID-19 antigen test performance becomes available.

The FDA is working collaboratively with government and academic partners to perform studies and make the results of these studies available.

The FDA encourages at-home COVID-19 antigen test developers with a current Emergency Use Authorization (EUA) to engage with us about how they may be able to use these study results.

If you think you had a problem with your COVID-19 test, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.

Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

If you have questions, email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100.

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At-Home COVID-19 Tests-Reduce Your Risk of False Negative Results - FDA.gov

Cancer care requires close physical and emotional interactions, but with threats of COVID-19 infection looming, many physicians lost the personal touch to patient care, oncologist Jalal Baig, MD, wrote in an op-ed for The Washington Post.

The personal elements that made patient interactions meaningful only began to return after the COVID-19 vaccines and other public health measures, Dr. Baig wrote. Even though there were many close encounters with COVID-19, Dr. Baig said the ability to stand close together, have face-to-face talks, and other types of close contact previously considered mundane have had a great impact on his practice.

"In the tumult and uncertainty of the pandemic, the one constant I can provide patients is my understanding, attention and a chair next to them," Dr. Baig wrote. "Accepting some risk of infection is how we bravely move forward in this coronavirus-altered world. Especially when trying to preserve something as sacred as the bonds that hold oncology together."

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Viewpoint: COVID-19 shots saved the patient-oncologist relationship - Becker's Hospital Review

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Throughout this pandemic, I have led the effort to uncover the origins of this virus that has killed over 6 million people worldwide.

Shockingly, with over 1 million Americans killed and trillions of dollars spent, last Wednesday was the first congressional hearing on the dangerous, virus-enhancing research known as gain-of-function and its relation to the origins of the COVID-19 pandemic.

The purpose of this hearing by the Senate Subcommittee on Emerging Threats and Spending Oversight was to discuss, as our name implies, the emerging threat posed by gain-of-function research.

FAUCI BLASTED FOR JOKE THAT HE CREATED COVID-19 IN HIS KITCHEN: 'TONE DEAF'

We heard from a panel of three witnesses Dr. Richard H. Ebright, Ph.D., laboratory director of Waksman Institute of Microbiology, Dr. Steven Quay, M.D., Ph.D., CEO at Atossa Therapeutics, Inc., and Dr. Kevin M. Esvelt, Ph.D., assistant professor of Media Arts & Sciences of MIT Media Lab all of whom are extraordinarily accomplished experts in the scientific community. We are grateful for their work, and we are grateful to them for taking the time to appear before the committee.

A security person moves journalists away from the Wuhan Institute of Virology (AP Photo/Ng Han Guan, File)

As we discussed in the hearing, gain-of-function research is a controversial scientific research method involving the manipulation of pathogens to give them a new aspect or ability, such as making viruses more transmissible or dangerous to humans.

As Dr. Richard Ebright said in the hearing, "Gain-of-function research of concern involves the creation of new health threats health threats that did not exist previously and that might not come to exist by natural means for tens, hundreds, or thousands of years."

Why in the world would we willingly create a more-transmissible or more-dangerous virus that has the potential to unleash a global pandemic that threatens the lives of millions?

Dr. Stephen Quay explained, theGlobal Virome Projectsgoal aims to "collect the estimated 500,000 unknown viruses that are capable of infecting humans and bring them back to a laboratory near you. What could go wrong?"

Dr. Kevin Esvelt highlighted during the hearing exactly what could go wrong. He said, scientists "never considered that these advances in technology would allow a single skilled terrorist to unleash more pandemics at once than would naturally occur in a century."

We also learned during the hearing that Chief Medical Advisor to the President Dr. Anthony Fauci has been lying to us shocking, I know.

The three elite scientists all agreed that this was dangerous research. Two of the three absolutely said it wasgain-of-function. The third said it wasdangerous researchand should have gone before a committee.

This is all despite Fauci saying that the NIH has never funded gain-of-function research in Wuhan, and it has been reviewed and doesnt meet the definition set by the Department of Health and Human Services P3CO review committee, which is responsible for evaluating the risks & benefits of such research.

The P3CO committee was formed in 2017. This was after gain-of-function research funding was suspended by the Obama administration in 2014 and was only allowed to restart in 2017 because of this new committee review process.

We learned that theP3CO committee that is supposed toreview these viruses is secret.We don't know the names of the committee members.We don't have any records of theirmeetings.It's top-secret.Congress is not allowed to know.The public isnt allowed to know.

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We do know that they've metthree times and have reviewed three of thousands of gain-of-function research project proposals, none of which have been related to the Wuhan Institute of Virology.

The issue with all of this is that Fauci unequivocally claims that the NIH does not fund gain-of-function research in Wuhan, but how would he know that since the P3CO committee has never reviewed research in the Wuhan lab?

People wearing face masks walk near blossoming trees at a public park in Beijing, Thursday, April 14, 2022. (AP Photo/Mark Schiefelbein)

We learned a lot of things from this hearing, but its only the start.

We reconfirmed thatFauci is not being honestwith us.Yes, theNIH funded gain-of-functionresearch.Yes, it was dangerous.And yes, nobody looked over or reviewed the research.

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While there still seems to be a significant lack of curiosity on the part of Democrats, I am sure each member of Congress can agree that we need stronger government oversight of how our tax dollars are being used to create viruses capable of causing pandemics.

We may never know whether the pandemic arose from a lab in Wuhan or occurred naturally, but the emergence of COVID-19 serves as a reminder that dangerous research conducted in a secretive and totalitarian country is simply too risky to fund, and greater oversight must take place.

CLICK HERE FOR MORE FROM SEN. RAND PAUL

Republican Rand Paul represents Kentucky in the United States Senate. He is the author of "TheCase Against Socialism" (Broadside Books, October 15, 2019).

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COVID-19 gain-of-function research too dangerous for Fauci to work with China - Fox News

STATEN ISLAND, N.Y. As President Joe Biden comes in and out of isolation following recent coronavirus (COVID-19) infections and antigen tests, you may be asking yourself how to know for sure its OK to return to normal life after testing positive for the virus.

Biden had two negative antigen tests before leaving isolation the first time, after taking the antiviral medication Paxlovid, yet he still experienced a rebound infection and tested positive again, requiring a return to isolation.

And while Moderna and Pfizer two-dose vaccine series still offer protection against severe illness and death from COVID-19, and vaccine makers are looking to create booster vaccine doses that target the extremely contagious subvariants of omicron, BA.4 and BA.5, even vaccinated New Yorkers continue to test positive in their own home, leaving the question of isolating and ending quarantine a very private one.

Are antigen tests required to end quarantine?

So, what about ordinary citizens who get infected with COVID-19? Are we expected to take as many tests as Biden before ending isolation?

Well, no, according to the Centers for Disease Control and Prevention (CDC), whose guidance does not specifically recommend a negative antigen test, which is performed at home and provides results in less than 20 minutes after collecting samples with a nasal swab, in order to end isolation after testing positive for COVID-19.

CDC protocols call for children and adults who have tested positive for COVID and experienced mild symptoms to isolate for a minimum of five days with day one being the day after the positive test and end isolation at that time, as long as they have been fever-free for at least 24 hours.

They are expected to wear a mask around others for five additional days, the CDC advises.

People who test positive but remain asymptomatic can end isolation at least five days after the first positive test, with day 0 being the date their specimen was collected for the positive test. This is only for people who can continue to wear a properly well-fitted mask around others for five additional days. However, if symptoms develop after a positive test, their five-day isolation period should start over, and day 0 changes to the first day of symptoms, the CDC says.

The recommendations change for those who are severely ill, requiring hospitalization. They are expected to extend isolation to al least 10 days and up to 20 days after symptom onset and after fever ends without a fever reducer, the CDC says.

Benefits of a negative test

For those who prefer the confirmation of a rapid antigen test, the CDC suggests they take such a test later in your infection period for the most reliable results.

And some medical experts, and your own private doctor, may suggest that an at-home rapid antigen test should be negative before a person returns to work and social gatherings. And it might make you feel better too.

Given that a substantial portion of people do have a rapid positive test after five days, I think an updated recommendation should include people having a negative rapid test before coming out of isolation for COVID, Tom Inglesby, director of the Johns Hopkins Center for Health Security, told The Washington Post. Inglesby was formerly the Biden administrations senior adviser on testing.

Another twist that makes spread control difficult, medical experts say, is that the COVID-19 virus is most transmissible a day or two before symptoms even arrive, continuing for two or three days after.

And the CDC says it is very unlikely to pass along the virus after 10 days, even if a patient still is testing positive.

Yet, a negative at-home test can be very reassuring, Amy Barczak, an infectious-diseases expert at Massachusetts General Hospital who has researched how long patients with COVID can shed virus, told The Washington Post.

And the tests are much more available now than they were when the CDC first released its guidance and provided its online self-checking calculator for patients to determine where they are in the isolation process.

When should you test?

If you have COVID-like symptoms, the CDC recommends testing with an at-home antigen test immediately.

If you are negative, it is unlikely you have COVID.

If youve been exposed to someone who tests positive, the CDC suggests a PCR test to be certain.

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For those who have coronavirus, how do you determine when you are no ...

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Our COVID Q&A with Watson is an AI-powered chatbot that addresses consumers' questions and concerns about COVID-19. It's built on the IBM Watson Ads Builder platform, which utilizes Watson Natural Language Understanding, and proprietary, natural- language-generation technology. The chatbot utilizes approved content from the CDC and WHO. Incidents information is provided by USAFacts.org.

To populate our Interactive Incidents Map, Watson AI looks for the latest and most up-to- date information. To understand and extract the information necessary to feed the maps, we use Watson Natural Language Understandingfor extracting insights from natural language text and Watson Discovery for extracting insights from PDFs, HTML, tables, images and more.COVID Impact Survey, conducted by NORC at the University of Chicago for the Data Foundation

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Shippen Township, PA Coronavirus Information - The Weather Channel

"This morning, the president's SARS-CoV-2 antigen testing was negative for a second consecutive day," presidential physician Kevin O'Connor wrote in a letter Sunday. "He will safely return to public engagement and presidential travel."

Biden tested negative on an antigen test Saturday as well, but remained in isolation until Sunday morning before departing for Rehoboth Beach, Delaware.

Departing the White House for Rehoboth Beach, the President told reporters he was "feeling good," saying, "After 18 days, I'm clear!"

According to the US Centers for Disease Control and Prevention, "People with recurrence of COVID-19 symptoms or a new positive viral test after having tested negative should restart isolation and isolate again for at least 5 days."

The CDC issued a health alert to doctors on May 24 advising that Covid-19 symptoms sometimes come back, and that may just be how the infection plays out in some people, regardless of whether they're vaccinated or treated with medications such as Paxlovid. The CDC said that most rebound cases involve mild disease and that there have been no reports of serious illness.

Biden is fully vaccinated and received two booster shots. He received his first two doses of the Pfizer/BioNTech Covid-19 vaccine ahead of his inauguration in January 2021, his first booster shot in September and his second booster vaccination in March.

This story and headline have been updated with additional developments Sunday.

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President Joe Biden officially cleared to emerge from isolation following rebound Covid-19 case - CNN

Michigan reported 20,173 new confirmed and probable COVID-19 cases over the past week, up from the 19,653 cases recorded in the previous week.

There were 106 COVID-19 deaths over the past week, according to the Michigan Department of Health and Human Services, which releases weekly totals every Tuesday.

The weekly case totals have been climbing every week for the past several weeks.

Wayne, Oakland and Macomb counties have all moved into the red or high designation for COVID-19 transmission, under which the Centers for Disease Control and Prevention recommends that everyone should wear a mask in public.

The three counties had been in the green (low) or yellow (medium) classifications until recently, which carry less concern about COVID-19 transmission.

The CDC classifies each county based on several factors, including the number of hospitalizations and the current level of new cases per 100,000 population.

In the red classification, the CDC recommends:

Wearing a mask indoors in public and on public transportation.

Staying up to date with COVID-19 vaccines.

Getting tested if you have symptoms.

If you are at high risk for severe illness from COVID-19, consider taking additional precautions. To learn more, go to https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html.

In the yellow category, the CDC recommends only that people with certain health conditions wear a mask in public.

In the green category, the CDC recommends wearing a mask only if you have symptoms, a positive test or exposure to someone with COVID-19.

The CDC issues recommendations on mask usage but does not mandate it. State and local governments have not issued any mask mandates since the tri-county area fell into the red designation.

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Statewide number of COVID-19 cases climbing The Morning Sun

Although COVID-19 cases in Danville and Pittsylvania County are at least three times higher now than a year ago, the increased infection level isnt sounding alarm bells.

For a population that has broken free of pandemic precautions, its business and life as normal, as if a mutating virus isnt still lurking.

Another reason for the subdued response is because to date these subvariants arent causing an increase in severe COVID-19 illnesses, according to Brookie Crawford, a spokesperson for the Virginia Department of Health.

While cases are up, reports of severe cases, hospitalizations and visits to the emergency department are not climbing, she told the Register & Bee on Friday.

Sovah Health is currently treating 15 patients for COVID-19 between campuses in Danville and Martinsville, spokesperson Hailey Fowlkes confirmed Friday. Thats about five more than the middle of July.

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Additionally, COVID-19 treatments are available for people who may need it, and can help prevent severe illness in certain patients to help keep them out of the hospital, Crawford explained.

Most people with mild symptoms recover with at-home treatments.

People who are at high risk for severe illness should contact their health care provider after a positive test or after symptoms start [even if mild], to see if they may need treatment, she said. They may benefit from medications to help reduce the risk of severe illness and death from COVID-19.

However, to be effective, those treatments should begin in the first few days of experiencing symptoms.

The Pittsylvania-Danville Health District is in a slow-growth trajectory, meaning cases are rising but not at a level to be considered a surge.

The proof is in the pudding, Dr. Scott Spillmann, director of the Pittsylvania-Danville Health District, said about the current caseloads. He said while cases are up, they are starting to see a decrease.

By the numbers, Danville is adding about 25 new COVID-19 cases per day. Over in Pittsylvania County, 35 new cases are loaded into the record books each day. But those figures dont count the at-home test kits widely available now.

In fact, the University of Virginia now estimates that for every one COVID-19 case officially recorded, there are about 16 others that fly under the radar.

With home tests, people are more likely to take test and to take action, Spillmann said. Hospitalizations and deaths are down.

In Virginia, theres a mixed bag of trajectories, according to UVas latest report Friday. The Pittsylvania-Danville Health District is in a slow growth category, meaning cases are rising but not at a level to be considered a surge.

Other districts are showing a decline as national rates also start to slow.

Danville and Pittsylvania County are in the medium community level for COVID-19, as defined by the Centers for Disease Control and Prevention.

However, 122 out of the 133 localities in the commonwealth are in medium or high community levels, designated by the Centers for Disease Control and Prevention.

Danville and Pittsylvania County are in the medium level, which carries a recommendation for people at high-risk for illnesses to consider wearing a mask. Over in neighboring Halifax County, the level is high, which triggers a suggestion for everyone to mask up in public indoor settings.

Throughout the pandemic, masking has been especially important for asymptomatic people individuals who show no signs of the illness, but are unknowingly spreading it to others.

Asymptomatic patients will always be of concern, however we hope that they are vigilant to any minor symptom or whether they have been around others who were positive or symptomatic, Chris Garrett, local health emergency coordinator with the health department, told the Register & Bee.

Those positive cases with minimal symptoms that continue on with their daily lives do put those with immunity issues at greater risk of severe illness, he said.

Everyone should stay alert for signs and symptoms of COVID-19, Crawford explained.

Core public health measures, such as getting vaccinated and boosted when you are eligible, getting tested if you have COVID-19 symptoms or an exposure, following your health care providers treatment recommendations, staying home and separating from others when recommended, and wearing masks, remain extremely useful to control the virus and surge of cases, she said.

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COVID-19 cases rising again in Dan River Region, but hospitalizations stay steady - GoDanRiver.com

Mike Stucka USA TODAY NETWORK| The Shelby Star

New coronavirus cases leaped in North Carolina in the week ending Sunday, rising 12.6% as 33,932 cases were reported. The previous week had 30,130 new cases of the virus that causes COVID-19.

North Carolina ranked eighth among the states where coronavirus was spreading the fastest on a per-person basis, a USA TODAY Network analysis of Johns Hopkins University data shows. In the latest week coronavirus cases in the United States increased 7.4% from the week before, with 906,593 cases reported. With 3.15% of the country's population, North Carolina had 3.74% of the country's cases in the last week. Across the country, 28 states had more cases in the latest week than they did in the week before.

Cleveland County reported 369 cases and one death in the latest week. A week earlier, it had reported 326 cases and zero deaths. Throughout the pandemic it has reported 32,047 cases and 406 deaths.

Within North Carolina, the worst weekly outbreaks on a per-person basis were in Richmond County with 587 cases per 100,000 per week; Duplin County with 552; and Chowan County with 545. The Centers for Disease Control says high levels of community transmission begin at 100 cases per 100,000 per week.

Adding the most new cases overall were Mecklenburg County, with 3,897 cases; Wake County, with 3,434 cases; and Guilford County, with 1,339. Weekly case counts rose in 77 counties from the previous week. The worst increases from the prior week's pace were in Mecklenburg, Forsyth and Guilford counties.

>> See how your community has fared with recent coronavirus cases

Across North Carolina, cases fell in 22 counties, with the best declines in Cumberland County, with 1,264 cases from 1,453 a week earlier; in Durham County, with 1,130 cases from 1,235; and in McDowell County, with 124 cases from 187.

In North Carolina, 48 people were reported dead of COVID-19 in the week ending Sunday. In the week before that, 40 people were reported dead.

A total of 2,983,130 people in North Carolina have tested positive for the coronavirus since the pandemic began, and 25,483 people have died from the disease, Johns Hopkins University data shows. In the United States 91,316,648 people have tested positive and 1,029,926 people have died.

>> Track coronavirus cases across the United States

USA TODAY analyzed federal hospital data as of Sunday, July 31. Likely COVID patients admitted in the state:

Likely COVID patients admitted in the nation:

Hospitals in 24 states reported more COVID-19 patients than a week earlier, while hospitals in 21 states had more COVID-19 patients in intensive-care beds. Hospitals in 30 states admitted more COVID-19 patients in the latest week than a week prior, the USA TODAY analysis of U.S. Health and Human Services data shows.

The USA TODAY Network is publishing localized versions of this story on its news sites across the country, generated with data from Johns Hopkins University and the Centers for Disease Control. If you have questions about the data or the story, contact Mike Stucka at mstucka@gannett.com.

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Cleveland County reported 369 additional COVID-19 cases this week - Shelby Star

CLEVELAND, Ohio Two and a half years into the greatest pandemic most of us have ever known, life has mostly returned to normal. At this point, if you havent gotten COVID-19 at least once, youre in the minority.

But what if you get COVID-19 now? How long are you considered contagious? When is it safe to circulate?

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So you recently got COVID-19; are you still contagious? - cleveland.com