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First at-home syphilis antibody test gets FDA authorization as STD cases spike in US

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First at-home syphilis antibody test gets FDA authorization as STD cases spike in US

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The U.S. Food and Drug Administration has granted marketing authorization for the first at-home syphilis test.

The over-the-counter First To Know Syphilis Test, made by NOWDiagnostics in Arkansas, detects antibodies for Treponema pallidum (syphilis), according to a press release.

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The test, which does not require a prescription, takes about 15 minutes to administer using only a drop of blood — “like a finger prick,” the company said.

AS SYPHILIS CASES SURGE IN THE US, HERE’S WHAT INFECTIOUS DISEASE EXPERTS WANT YOU TO KNOW

Results will be positive for those experiencing a current syphilis infection — as well as for those who have been previously diagnosed, even if they were successfully treated.

The test results are not sufficient to diagnose syphilis alone, however, and should be followed by additional testing from a provider to confirm the diagnosis, according to the FDA.

The First To Know Syphilis Test, pictured here, uses a blood sample to detect the infection. (NOWDx)

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A clinical study of 1,270 people found the product “easy to use,” a press release from NOWDiagnostics noted.

The study results showed that the test correctly identified 99.5% of negative results and 93.4% of positive diagnoses.

TEXAS CITY REPORTS SYPHILIS OUTBREAK AMID ‘LIMITED SUPPLY’ OF PENICILLIN DRUG

“With FDA authorization now granted, we are proud to offer the first test of its kind that provides highly accurate results in just minutes, using a single drop of blood and without the need for a buffer,” NOWDiagnostics CEO Rob Weigle told Fox News Digital via email. 

“This breakthrough in diagnostic testing empowers individuals to take control of their health from the privacy of their own home, playing a critical role in early detection and treatment, and ultimately helping to slow the spread of syphilis and protect public health.”

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First To Know Syphilis Test Box

“This is a great advance and has been vetted for accuracy,” one doctor commented. (NOWDx)

Fox News medical contributor Dr. Nicole Saphier said she considers at-home tests to be “great,” as they often lead to more people being tested who would not otherwise visit the doctor.

“Anything that increases access to health information while also being cost-effective is a positive step in the right direction,” the New York-based doctor told Fox News Digital.

Efforts to stop the surge

There has been a major rise in syphilis cases in the U.S. over the last few years.

Cases spiked by 80% between 2018 and 2022, according to data from the Centers for Disease Control and Prevention (CDC).

SYPHILIS CASES SURGE IN THE US, REACHING LEVELS UNSEEN SINCE 1950

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In 2022, more than 3,700 cases of congenital syphilis were reported among newborns, the agency stated.

Earlier this year, the Department of Health and Human Services established the National Syphilis and Congenital Syphilis Syndemic (NSCSS) Federal Task Force to help combat the surging numbers.

split image of syphilis bacteria and at home test

Study results showed that the test correctly identified 99.5% of negative results and 93.4% of positive diagnoses. (iStock; NOWDx)

In addition to the task force, the FDA assured that the authorization of this new at-home test will help to “reverse the recent dramatic rise of STIs in the United States.”

“If left untreated, syphilis can seriously damage the heart and brain and can cause blindness, deafness and paralysis,” the FDA wrote in the press release. 

HAWAII HEALTH OFFICIALS CALL FOR ACTION AS SYPHILIS CASES RISE

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“When transmitted during pregnancy, it can cause miscarriage, lifelong medical issues and infant death.”

Fox News senior medical analyst Dr. Marc Siegel told Fox News Digital that these advancements could also play into the CDC’s new program, DOXY PEP, which aims to prevent “post-exposure prophylaxis with doxycycline for chlamydia, gonorrhea and syphilis.”

“When transmitted during pregnancy, [syphilis] can cause miscarriage, lifelong medical issues and infant death.”

The program has been shown to “markedly decrease clinical infection,” said New York-based Siegel.

Siegel called the new syphilis test “especially important,” as “the earlier syphilis exposure/diagnosis is made the better.”

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Blood sample positive with syphilis

The authorization of the new at-home test will help to “reverse the recent dramatic rise of STIs in the United States,” the FDA stated. (iStock)

Michelle Tarver, M.D., PhD, acting director of the FDA’s Center for Devices and Radiological Health, wrote in a statement that advancements in tests for STIs can “give patients more information about their health from the privacy of their own home.” 

“Access to home tests may help increase initial screening for syphilis, including in individuals who may be reluctant to see their health care provider about possible sexually transmitted infection exposure,” she said.

HOUSTON HEALTH OFFICIALS REPORT SYPHILIS OUTBREAK, 128% SPIKE IN CASES AMONG WOMEN

This can lead to increased lab testing to confirm the diagnosis, Tarver added, which can increase treatment and help curb the spread.

Man having appointment with specialist in clinic

The FDA confirmed that false negative results may occur, which can cause delays in treatment and further spread of the infection. (iStock)

Saphier added that as syphilis cases rise, it’s “disappointing to see so many advanced cases of a disease that is otherwise treatable.” 

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“While prevention is always the best method, early detection and treatment intervention are essential to not only result in the best health outcome, but also decrease the overall cost burden on society — because advanced disease and disability are expensive,” she said. 

Potential limitations

Saphier shared some concerns about using at-home tests in detecting illness, as they are “often lower in accuracy than standardized laboratory testing.”

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“This may result in false negative results and a person who otherwise may require treatment not seeking it,” she said. 

“If someone is [at] high risk for syphilis exposure or having symptoms, they should skip the at-home testing and speak to their doctor.”

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The FDA confirmed that false negative results may occur, which could cause delays in treatment.

Illustration of syphilis bacterium

Congenital syphilis symptoms include sores and rashes on the skin, fever, jaundice, sneezing or runny nose and swollen spleen and liver, according to Mayo Clinic. (iStock)

“Results of the test alone should not be used to start, stop or change any treatments without a health care provider,” the FDA wrote in the press release.

“If someone is [at] high risk for syphilis exposure or having symptoms, they should skip the at-home testing and speak to their doctor.”

“In addition, individuals using this test who may have been recently exposed to syphilis should seek care from a health care provider for treatment and evaluation regardless of this test’s results.”

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Congenital syphilis symptoms include sores and rashes on the skin, fever, jaundice, sneezing or runny nose, and swollen spleen and liver, according to Mayo Clinic’s website.

If left untreated, later symptoms can include hearing loss, dental problems and “saddle nose,” a condition in which the bridge of the nose collapses.

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Words and game of Scrabble keep married couple in wedded bliss for decades

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Words and game of Scrabble keep married couple in wedded bliss for decades

A married couple who have long enjoyed the game of Scrabble both together and separately before they even met are never at a loss for words — and attribute their wedded bliss in part to their love of the nostalgic game.

They’re still playing in tournaments built around the game decades after they began doing so.

Graham Harding and his wife Helen Harding, both in their 60s, have been married for over 20 years.

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They met in the 1990s at Scrabble tournaments, as news agency SWNS reported.

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But it was a “special match” in 2000 that brought the couple together — and has kept them together now.

Graham and Helen Harding on their wedding day. They’ve been playing in Scrabble tournaments for some 30 years.  (Courtesy Graham and Helen Harding via SWNS)

Graham Harding is from the East Berkshire Scrabble Club, while his wife Helen is from the Leicester Scrabble Club in the U.K.

They have been taking part in the UK Open Scrabble Championship in Reading this week.

“The more words you know, the more ammunition you’ve got.”

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“Scrabble is all about having a good vocabulary,” said Graham Harding, SWNS noted.

7 HEALTHY LIFESTYLE CHANGES THAT COULD HELP REDUCE RISK OF DEPRESSION, SAYS STUDY: ‘ENORMOUS BENEFITS’

“But it is a Scrabble vocabulary — not necessarily everyday English.”

Added Helen Harding, “The more words you know, the more ammunition you’ve got.”

Graham and Helen Harding at their wedding.

Graham and Helen Harding’s wedding cake. They bonded over their love of Scrabble – and are still playing in tournaments together.  (Courtesy Graham and Helen Harding via SWNS)

The couple said they were “vague acquaintances” for about five years after they first met.

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Then they got together after a special match in Swindon.

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They maintained a long-distance relationship before they got married in 2004.

The couple even brought their Scrabble board to their wedding. 

Graham and Helen Harding at their wedding.

The couple likely have played thousands of games between them.  (Courtesy Graham and Helen Harding via SWNS)

It featured a message with Scrabble pieces that said, “Congratulations on your wedding day” — while their wedding cake said, in Scrabble letters, “Helen and Graham.”

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They each took up the hobby early in life well before they met each other. 

The tournament that’s been taking place this week is the first since the COVID pandemic after a five-year break — and the couple has played some two dozen games in it as of Friday, SWNS reported. 

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Deep sleep can keep two big health problems at bay, new studies suggest

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Deep sleep can keep two big health problems at bay, new studies suggest

It might be worth working a little bit harder to get that much-desired, but often elusive, good night’s sleep.

Deep sleep clears the mind of waste just as a “dishwasher” cleans dirty plates and glasses, just-published research suggests — and there’s more.

The findings also offer insights into how sleeping pills may disrupt the “brainwashing” system — potentially affecting cognitive function for people over the long run.

ANOTHER REASON TO GET MORE SLEEP AND THIS ONE MIGHT SURPRISE YOU

Study senior author professor Maiken Nedergaard of the University of Rochester and the University of Copenhagen said norepinephrine (a neurotransmitter and hormone) triggers blood vessels to contract — generating slow pulsations that create a rhythmic flow in the surrounding fluid to carry away waste, news agency SWNS noted.

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Said Nedergaard, “It’s like turning on the dishwasher before you go to bed and waking up with a clean brain. . . . We’re essentially asking what drives this process and trying to define restorative sleep based on” this “glymphatic clearance.”

“It’s like turning on the dishwasher before you go to bed and waking up with a clean brain.” (iStock)

The brain has a built-in waste removal process – the glymphatic system – that circulates fluid in the brain and spinal cord to clear out waste, according to the scientists. 

The process helps remove toxic proteins that form sticky plaques linked to neurological disorders, such as Alzheimer’s disease.

But the scientists indicated that what drives the system was unclear until now, according to the study.

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Is all sleep created equal? The researchers wanted to find out.

To find clues, Nedergaard and her team looked into what happens in mice when their brains sleep, as SWNS reported of the study. The team focused on the relationship between norepinephrine and blood flow during deep sleep.

TRUMP’S DAYLIGHT SAVING PLAN AND SLEEP: WHAT YOU MUST KNOW

They found that norepinephrine waves correlate to variations in brain blood volume — suggesting that norepinephrine triggers a rhythmic pulsation in the blood vessels. The researchers then compared the changes in blood volume to brain fluid flow.

The brain fluid flow fluctuates in correspondence to blood volume changes, suggesting the vessels act as pumps to propel the surrounding brain fluid to flush out waste.

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Senior couple sleeping

During deep sleep, toxic proteins that form sticky plaques linked to neurological disorders such as Alzheimer’s disease are removed, scientists say in a new study.  (iStock)

Natalie Hauglund of the University of Copenhagen and the University of Oxford, the study’s lead author, said, “You can view norepinephrine as [the] conductor of an orchestra.” 

She added, “There’s a harmony in the constriction and dilation of the arteries, which then drives the cerebrospinal fluid through the brain to remove the waste products.”  

‘I CAN’T SLEEP BECAUSE OF RACING THOUGHTS AT NIGHT — HOW CAN I STOP THEM?’: ASK A DOCTOR

Hauglund said she wanted to understand whether all sleep is created equal. 

To find out, the research team administered zolpidem, a common drug to aid sleep, to mice.

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“If people aren’t getting the full benefits of sleep, they should be aware of that, so they can make informed decisions.” 

They found that the norepinephrine waves during deep sleep were 50% lower in zolpidem-treated mice than in naturally sleeping mice. 

Although the zolpidem-treated mice fell asleep more quickly — fluid transport into the brain dropped more than 30%, as SWNS reported.

man sleeps in bed

Two new studies indicate the importance of getting a good night’s sleep — with one study saying a lack of sleep may be sabotaging the brain’s ability to keep intrusive thoughts at bay. (iStock)

The researchers say their findings, published in the journal Cell, suggest that the sleeping aid may disrupt the norepinephrine-driven waste clearance during sleep.

Hauglund said, “More and more people are using sleep medication, and it’s really important to know if that’s healthy sleep. If people aren’t getting the full benefits of sleep, they should be aware of that, so they can make informed decisions.” 

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The research team said the findings likely apply to humans, who also have a glymphatic system, although it requires further testing.

Nedergaard added, “Now we know norepinephrine is driving the cleaning of the brain, we may figure out how to get people a long and restorative sleep.”

For more Health articles, visit www.foxnews.com/health

Meanwhile, a lack of sleep may be doing more damage than just making people groggy.

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It could be sabotaging the brain’s ability to keep intrusive thoughts at bay.

young woman asleep

Anyone who suffers from sleep deprivation may find that the brain’s defense against unwanted memories is weakened, say experts. (iStock)

Another new study, this one published in the Proceedings of the National Academy of Sciences, found that sleep deprivation weakens the brain’s defense against unwanted memories, allowing them to flood the mind, according to the New York Post. 

“We show that sleep deprivation disrupts prefrontal inhibition of memory retrieval, and that the overnight restoration of this inhibitory mechanism is associated with time spent in rapid eye movement (REM) sleep,” the scientists said.

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How Kathy Bates Lost 100 Lbs—Plus Her Tips for Sustainable Weight Loss

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How Kathy Bates Lost 100 Lbs—Plus Her Tips for Sustainable Weight Loss


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Kathy Bates Weight Loss: Tips That Helped Her Lose 100 Lbs | Woman’s World




















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