Health
First at-home syphilis antibody test gets FDA authorization as STD cases spike in US
![First at-home syphilis antibody test gets FDA authorization as STD cases spike in US First at-home syphilis antibody test gets FDA authorization as STD cases spike in US](https://static.foxnews.com/foxnews.com/content/uploads/2024/08/iStock-1438694157.jpg)
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.
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.
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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)
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.
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“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.”
![First To Know Syphilis Test Box](https://a57.foxnews.com/static.foxnews.com/foxnews.com/content/uploads/2024/08/1200/675/First-To-Know-Syphilis-Test-Box-Only_Landscape_Credit-NOWDx.jpg?ve=1&tl=1)
“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
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](https://a57.foxnews.com/static.foxnews.com/foxnews.com/content/uploads/2024/08/1200/675/syphilis-test-split.png?ve=1&tl=1)
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.
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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.”
![Blood sample positive with syphilis](https://a57.foxnews.com/static.foxnews.com/foxnews.com/content/uploads/2024/08/1200/675/iStock-820736040.jpg?ve=1&tl=1)
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.
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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](https://a57.foxnews.com/static.foxnews.com/foxnews.com/content/uploads/2024/08/1200/675/iStock-1438694157.jpg?ve=1&tl=1)
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.”
“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.”
For more Health articles, visit www.foxnews.com/health
The FDA confirmed that false negative results may occur, which could cause delays in treatment.
![Illustration of syphilis bacterium](https://a57.foxnews.com/static.foxnews.com/foxnews.com/content/uploads/2024/08/1200/675/iStock-174831251.jpg?ve=1&tl=1)
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.”
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.
![](https://newspub.live/wp-content/uploads/2022/03/np-logo.png)
Health
Best HIIT Workout for Women: 10 Minutes Every Other Day Boosts Endurance and Helps With Weight Loss
![Best HIIT Workout for Women: 10 Minutes Every Other Day Boosts Endurance and Helps With Weight Loss Best HIIT Workout for Women: 10 Minutes Every Other Day Boosts Endurance and Helps With Weight Loss](https://www.womansworld.com/wp-content/uploads/2024/08/RL-featured-image2.png)
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Health
Dementia has 2 shocking new risk factors, study finds, with total of 14 now on list
![Dementia has 2 shocking new risk factors, study finds, with total of 14 now on list Dementia has 2 shocking new risk factors, study finds, with total of 14 now on list](https://static.foxnews.com/foxnews.com/content/uploads/2024/08/vision-cholesterol-split.jpg)
Two surprising new risk factors for Alzheimer’s disease are noted in a new study.
Untreated vision loss and high levels of LDL cholesterol have been linked to a greater chance of developing the common dementia type.
Low-density lipoprotein (LDL), which is sometimes called “bad cholesterol,” is associated with negative health effects when present in high amounts.
HIGH BLOOD PRESSURE AND ALZHEIMER’S DISEASE COULD GO HAND IN HAND, STUDY FINDS
Researchers from University College London led the study, published in The Lancet on Aug. 10.
The findings were also presented at the Alzheimer’s Association International Conference (AAIC) in Philadelphia on July 31.
Untreated vision loss and high levels of LDL cholesterol have been linked to a greater chance of developing Alzheimer’s. (iStock)
Vision loss and high LDL cholesterol join a list of 12 other risk factors the researchers previously identified in 2020.
Those 12 are hearing loss, lower education, smoking, hypertension, obesity, physical inactivity, depression, diabetes, excessive alcohol consumption, air pollution, traumatic brain injury and social isolation.
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To identify the two new risk factors, the researchers analyzed dozens of recent studies on vision loss and high cholesterol.
The 14 total factors are responsible for roughly half of dementia cases globally, the researchers stated, which means eliminating them could potentially prevent many cases.
![Amyloid beta](https://a57.foxnews.com/static.foxnews.com/foxnews.com/content/uploads/2024/07/1200/675/amyloid-beta.jpg?ve=1&tl=1)
About half of all Alzheimer’s cases can be attributed to 14 total factors, the researchers stated. (iStock)
“Some dementia risk factors, such as alcohol consumption and physical exercise, can be managed by changing your lifestyle, but many must be addressed on a societal level,” Fiona Carragher, chief policy and research officer at the Alzheimer’s Society in the U.K., said in a press release.
(The study was partly funded by the Alzheimer’s Society.)
“Social isolation, education inequalities and air pollution are beyond individuals’ control and require public health interventions and joint action between government and industry.”
“I tell patients all the time, ‘if it’s healthy for the heart, it’s healthy for the brain.’”
Dr. Earnest Lee Murray, a board-certified neurologist at Jackson-Madison County General Hospital in Jackson, Tennessee, was not involved in the study but said it “substantiates a lot of things we have known about dementia for several years.”
He told Fox News Digital, “The study in Lancet shows higher levels of LDL (the bad cholesterol) — which is often related to diet and lifestyle choices — is related to a greater chance of developing a dementia process.”
![To prevent vision loss, the U.S. Centers for Disease Control and Prevention (CDC) recommends getting regular eye exams.](https://a57.foxnews.com/static.foxnews.com/foxnews.com/content/uploads/2024/08/1200/675/iStock-1798442060.jpg?ve=1&tl=1)
To prevent vision loss, the U.S. Centers for Disease Control and Prevention (CDC) recommends getting regular eye exams. (iStock)
“Genetic factors can play a role in elevated levels of LDL — however, even in these patients, diet modifications can be beneficial as well.”
The neurologist was also not surprised by the link between vision loss and development of dementia.
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“We have known for years that patients who have higher levels of education and are ‘well-read’ often develop dementia at a much later age,” Murray said.
“We rely heavily upon eyesight to be able to engage in our surroundings as well as stimulate cognitive thought.”
Reducing the risk
In his practice, Murray said, he is often asked about ways to prevent or reduce the risk of developing dementia at a later age.
“Patients have a good understanding of what a heart-healthy diet and lifestyle look like,” he told Fox News Digital.
![LDL cholesterol](https://a57.foxnews.com/static.foxnews.com/foxnews.com/content/uploads/2023/03/1200/675/LDL-cholesterol.jpg?ve=1&tl=1)
Low-density lipoprotein (LDL), which is sometimes called “bad cholesterol,” is associated with negative health effects when present in high amounts. (iStock)
The brain is a “very vascular organ,” the doctor pointed out — which means it is closely linked to the heart.
“I tell patients all the time, ‘If it’s healthy for the heart, it’s healthy for the brain,’” Murray said.
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“This not only includes dietary changes, such as lower fat/lower cholesterol diets, but also lifestyle modifications, such as smoking and alcohol cessation.”
There is also evidence that the Mediterranean diet can be beneficial in delaying the onset of dementia, Murray noted.
![Man exercising](https://a57.foxnews.com/static.foxnews.com/foxnews.com/content/uploads/2024/01/1200/675/man-working-out.jpg?ve=1&tl=1)
“Regular exercise is beneficial from a vascular standpoint, and can also help from a mental standpoint,” a neurologist said. (iStock)
“Regular exercise is beneficial from a vascular standpoint, and can also help from a mental standpoint,” he added.
Participating in cognitively stimulating activities is also known to delay the potential onset of dementia, according to Murray.
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“I tell my patients to find some cognitively challenging activity they enjoy, whether that’s working puzzles or reading challenging books,” he said.
“These activities can maintain a higher level of cognitive abilities and retard the onset of dementia.”
![Fresh vegetables](https://a57.foxnews.com/static.foxnews.com/foxnews.com/content/uploads/2024/05/1200/675/market3.jpg?ve=1&tl=1)
Eating a diet rich in fruits and vegetables can help to protect vision and promote heart health, doctors say. (iStock)
To prevent vision loss, the U.S. Centers for Disease Control and Prevention (CDC) recommends getting regular eye exams, wearing protective eye wear in high-risk environments and wearing sunglasses to prevent exposure to UV rays.
Knowing your family’s eye health history, eating a diet rich in fruits and vegetables, maintaining healthy blood sugar levels and avoiding smoking can also prevent vision loss, the agency added.
For more Health articles, visit www.foxnews.com/health
Fox News Digital reached out to the study researchers and the Alzheimer’s Society for additional comment.
Health
Blood banks searching for Type O blood amid emergency shortage: 'We always have a need'
![Blood banks searching for Type O blood amid emergency shortage: 'We always have a need' Blood banks searching for Type O blood amid emergency shortage: 'We always have a need'](https://static.foxnews.com/foxnews.com/content/uploads/2024/08/woman-donating-blood.jpg)
Las Vegas, Nevada – The nation is facing an emergency blood shortage, according to the American Red Cross.
Extreme heat and recent natural disasters are affecting the blood supply, the nonprofit says.
Not only is there a shortage of donations across the country, but there is also a specific need for Type O blood, according to Vitalant, an Arizona-based nonprofit that operates blood banks nationwide.
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To help meet the need, Vitalant is holding more than 50 blood drives this month in parts of Nevada.
“My best friend almost died in a car accident when I was, like, 19 or 20 — so I’ve seen the power of blood donations,” blood donor Nina Duren told Fox News.
The nation is facing an emergency blood shortage, according to the American Red Cross. (iStock)
Duren has been donating blood a couple of times a year for the last 15 years.
“It’s a life-saving thing I can do that costs me nothing but an hour of my time,” she said.
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Another donor, Sheila Macdonell Spiess, is a retired trauma nurse. In the 47 years of her nursing career, she said there has always been a need for blood.
“People are always in car accidents, stabbings, unfortunately, or gunshot wounds, or [there are] people with leukemia,” she told Fox News.
“We always have a need. It doesn’t matter what time of year.”
![Blood types](https://a57.foxnews.com/static.foxnews.com/foxnews.com/content/uploads/2024/08/1200/675/blood-types.jpg?ve=1&tl=1)
There is a specific need for Type O blood, according to Vitalant, an Arizona-based nonprofit that operates blood banks nationwide. (iStock)
As blood banks across the nation are running low on blood, some are placing an emphasis on one blood type over others.
“Type O is known as a universal donor,” said MacDonell Spiess. “So, if you came in, and we needed to give you blood right away … it would be O, because we don’t know if you’re A or B or AB. So we would give you O, because that’s called the universal type.”
Vitalant’s Type O supply hit an 18-month low in July.
Without Type O blood readily available, people in need may be turned away.
The organization is now working to build up a constant four-day supply.
![A donor with a needle in her arm as blood is collected](https://a57.foxnews.com/static.foxnews.com/foxnews.com/content/uploads/2024/08/1200/675/Screenshot-2024-08-15-at-6.50.15-PM.png?ve=1&tl=1)
A donor squeezes a stress ball while donating blood. As blood banks across the nation are running low on blood, some are placing an emphasis on one blood type over others. (Sunny Tsai/Fox News)
“If you just keep lowering the number and lowering the number … that just impacts how many people you can help, and honestly, no doctor wants to have to make that choice of saying you can’t be helped today,” Mike Doria, communication manager of Vitalant’s Southwest division, told Fox News.
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The American Red Cross’ entire inventory has shrunk by 25%, and the supply of donors has not kept up with the need.
“As an example, a trauma victim may require dozens of blood products,” Dr. Baia Lasky, American Red Cross’ divisional chief medical officer, told Fox News.
![American Red Cross](https://a57.foxnews.com/static.foxnews.com/foxnews.com/content/uploads/2024/08/1200/675/38b3fb6a-american-red-cross.jpg?ve=1&tl=1)
The American Red Cross’ entire inventory has shrunk by 25%, and the supply of donors has not kept up with the need. (Getty Images)
“And studies have demonstrated that every minute of delay in blood products in these situations will increase the risk of death by 5%.”
That means having blood available for donation at hospitals is “absolutely critical” to give people a chance of survival after emergencies, she added.
For more Health articles, visit www.foxnews/health
Blood cannot be stored long-term, which means nonprofits like American Red Cross and Vitalant consistently need donors.
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