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FDA withdraws pilot home tests for COVID-19 due to bacterial risk




On Friday, the U.S. Food and Drug Administration issued a warning to consumers and health care providers to stop using and discard the withdrawn COVID-19 pilot tests conducted by SD Biosensor, Inc. due to “serious concerns » bacterial contamination.

SD Biosensor is recalling all affected tests that Roche Diagnostics distributed to various retailers in an effort to stop the spread of the Covid-19 infection.

Throw away any pilot tests from Affected Lot Numbers and do not pour the liquid solution down the drain, the FDA said.

“Direct contact with a contaminated liquid solution may cause safety issues, and bacterial contamination may affect the performance of the test,” the FDA said in a statement. Press release.

The FDA has stated that the tests can be contaminated with bacteria such as Enterococcus, Enterobacter, Klebsiella and Serratia and cause an infection. Bacterial infections can cause disease in people with weakened immune systems.

If the liquid comes into contact with the skin or eyes, rinse them with plenty of water and consult a doctor if irritation persists. Signs and symptoms of a bacterial infection may include fever, discharge, or redness of the eyes.

About 500,000 tests have been donated to CVS Health, as well as about 16,000 tests to Amazon, according to the FDA, and the agency is working with Roche Diagnostics to determine how many tests have been sold to consumers.

The FDA notes that none of the affected batches were distributed through any federal testing programs.

“If you obtained your tests through the distribution or through other federal testing programs, they are not covered by this safety notice or product recall,” the post reads.


Carson Daly honored with Verywell Mind award for his work in mental health



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    Carson Daly honored with Verywell Mind award for his work in mental health


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TODAY’s Carson Daly has been honored on the first-ever Verywell Mind 25, an inspiring list of mental health activists who use their platforms to positively impact the world to destigmatize mental health.

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Satin false nails are luxurious lingerie for your fingertips



We’re well versed in how satin eyeshadow is the perfect compromise between metallic sheen and washed out color. The same can be said for the “satin fake nails” that give that same aesthetic to the fingertips and let you go full Y2K the next time you wear that timeless staple of the ’90s: the satin slip dress.

The effect, according to the famous nail master Betina Goldstein, created by rubbing pearl powder into nail polish, is designed to mimic the sheen and texture of real satin. The easiest way is to use a varnish that already contains finely ground shimmer, for example, Manicurist Nail polish in carnation or OPI Intentions – Rose Gold.

As with any decent beauty trend, “satin nails”, “satin nail polish” and “satin nails” are all search terms that use viral numbers. on TikTok, cumulatively racking up over 130 billion views. So it’s no wonder the internet is flooded with nail artists sharing different iterations of the trend, from cool lilac to cozy nudes, including oyster and copper.

The satin overlay manicure was also recently spotted by a celebrity at the Met Gala. Goldstein coated one layer Chanel Le Verney in 167 Ballerina with pearl powder Inventing Anna actress Julia Garner, which provided fashion with a new legion of fans.

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While nail art – think watercolor nails another sunflower nails– Like catnip for maximalists in manicure, satin manicure is a chic alternative for minimalists, especially in the run-up to wedding season. It’s also perfect if you want a pearly sheen but aren’t ready for vanilla chrome nails or completely iridescent pearlescent nails.

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Here’s how to track US COVID-19 levels after May 11



COVID-19 has caused the most recent public health crisis, but unlike the three years of the pandemic, there are signs that governments and public health authorities are ready to start putting the threat back into the past. May 5 World Health Organization (WHO) announced that COVID-19 is no longer a “Public Health Emergency of International Concern” but is now “an established and ongoing public health problem.” The WHO based its decision on the decline in deaths and hospitalizations from COVID-19 worldwide, as well as the growth of immunity against SARS-CoV-2 from both vaccines and infections.

In the US, President Joe Biden is pushing ahead with plans to end public health and national emergencies on May 11, which would mean the end of a number of disease containment measures.

These decisions do not mean that the COVID-19 pandemic is over, but that it is moving into a more manageable phase. In the US, this will mean the end of things like free tests and vaccines that have been provided by the federal government (and will continue to be provided until they run out). To receive and pay for them, people will now use insurance coverage or, for those who are not insured, public health services.

How the US monitors and controls COVID-19 will also change. “We have lived through a historic moment that forced the federal government to mobilize tremendous support to respond to COVID-19,” says Jen Cates, director of global health and HIV at the nonprofit Kaiser Family Foundation. “When the public health emergency is over, we will return to the normal system and not all of our problems will be solved.”

Here’s how COVID-19 data will change after the end of the public health emergency on May 11.

What will change:

Color cards will disappear

The U.S. Centers for Disease Control and Prevention (CDC) will stop tracking community levels of COVID-19: PCR-confirmed case counts down to the county level that states were required to report to the CDC. This aggregated information allowed the agency to provide people with an easy-to-understand color-based metric to determine whether cases are low (green), moderate (yellow) or high (red) where they live. This system has helped individuals, as well as organizations such as schools and hospitals, make decisions about whether to recommend behavioral changes, such as wearing a mask.

After May 11, states and jurisdictions will no longer be required to report cases to the CDC, so the data the agency receives will not allow them to accurately determine the burden of COVID-19 cases in any county.

Hospitalization data will replace it

The CDC will now rely on hospitalization data that hospitals will continue to report to the CDC. Hospitalization is “a major factor in the spread of COVID-19 in the community,” the doctor said. Brendan Jackson, CDC COVID-19 Response Lead, during a briefing. 5 May report, CDC scientists conducted an analysis comparing hospitalization data and its correlation with infection rates in the community, and found a 99% agreement between the two. “We’ll still be able to tell it’s snowing even if we no longer count every snowflake,” the doctor said. Nirav Shah, Chief Deputy Director of the CDC.

But instead of reporting admissions daily, as hospitals do now, they will report weekly.

Other systems, such as wastewater surveillance, will help provide insight into how COVID-19 cases can decrease and decrease across communities. CDC National Wastewater Surveillance System, launched in 2020, involves collecting wastewater and testing it for SARS-CoV-2 at hundreds of facilities covering 140 million people (about 40% of the US population). “Wastewater allows us to gain insight not only into COVID-19 but other infectious diseases as well,” Shah said. “This is one of those early sentinel markers that we use to see where things are going, and we intend to continue the investment the CDC has made in this system.”

PCR lab tests will no longer be tracked

After May 11, we will also no longer have information on the “positive rate” or percentage of positive COVID-19 tests in a given area. This is because to calculate this measure, the Centers for Disease Control and Prevention needs to have data from all lab results, including negative ones, to determine what percentage of the total is positive. But after May 11, most labs will no longer be required to report negative test results.

CDC will now rely on labs to voluntarily report data

While the CDC has agreements with some labs to continue reporting negative results, the agency is moving to include COVID-19 in its National Respiratory and Enteric Virus Surveillance System, a network of 450 labs across the country that test and voluntarily report respiratory disease results. . . The network does not include all laboratories testing for COVID-19, but it is a representative sample that will continue to provide information to the CDC on when and where new cases of COVID-19 may appear.

In addition, the agency will also receive data from its National Syndrome Surveillance Program, which collects emergency department data from 6,300 health facilities in all 50 states, the District of Columbia, and Guam. The network covers about 75% of all emergency visits in the US, and weekly estimates of how many people test positive for COVID-19 during visits could provide early clues as to whether cases are on the rise.

What will remain the same:

Vaccination data will continue to be tracked in the CDC COVID-19 Data Tracking System. Nearly all of the 64 states and jurisdictions (such as the Marshalls and Virgin Islands) that work with the CDC have signed data use agreements in which they will continue to provide information about how many shots they have received.

The CDC also wants to continue monitoring the side effects of the COVID-19 vaccine. WAERS system. V safe The system, which was created specifically to monitor side effects of the COVID-19 vaccine via a smartphone app, will no longer accept new reports, but the CDC plans to release a new version of V-safe later this year.

Deaths from COVID-19 will also continue to show up in the COVID-19 data tracker, but more accurately, Jackson said. Until now, deaths have been recorded by the date they were reported, which allowed for some lag and inaccuracies in comparing them with peak incidence. The CDC will move to reporting COVID-19 deaths based on death certificates that list the date of death, which is a more timely indicator.

The CDC will continue to conduct genomic sequencing of positive samples – both from people in the US and from travelers who have arrived from abroad and tested positive – to track new variants. Samples from the National Wastewater Surveillance System are also genetically sequenced, and together these sources are early indicators of new variants that may be causing infections in the US.

The CDC plans to launch a new COVID-19 data tracking website incorporating these changes on May 11, which will be updated weekly to keep the public informed of changing COVID-19 trends.

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