The U.S. Food and Drug Administration has approved the first syphilis home test.
The over-the-counter “First To Know Syphilis Test” from NOWDiagnostics in Arkansas detects antibodies to Treponema pallidum (syphilis), according to a press release.
The test is available over the counter and takes about 15 minutes. Only a drop of blood is needed – “like a finger prick,” says the company.
As the number of syphilis cases increases in the United States, infectious disease experts want to share the following
The results will be positive for those who currently have syphilis infection – as well as for those who have already been diagnosed with the infection, even if they have been successfully treated.
However, the test results alone are not enough to diagnose syphilis. According to the FDA, additional tests should be done by a doctor to confirm the diagnosis.
The First To Know Syphilis Test shown here detects the infection using a blood sample. (NOW x)
A clinical study involving 1,270 people found the product to be “easy to use,” according to a press release from NOWDiagnostics.
The study results showed that the test correctly identified 99.5% of negative results and 93.4% of positive diagnoses.
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“Now that we have received FDA approval, we are proud to offer the first test of its kind that delivers highly accurate results in just minutes, using a single drop of blood and without the need for a buffer,” Rob Weigle, CEO of NOWDiagnostics, told Fox News Digital via email.
“This breakthrough in diagnostic testing technology gives individuals the ability to monitor their health from home. It plays a critical role in early detection and treatment, ultimately helping to slow the spread of syphilis and protect public health.”
“This is a big step forward and its accuracy has been verified,” commented one doctor. (NOW x)
Fox News medical writer Dr. Nicole Saphier said she thinks home tests are “great” because they often lead to more people getting tested who otherwise wouldn’t go to the doctor.
“Anything that improves access to health information while being cost-effective is a positive step in the right direction,” the New York-based doctor told Fox News Digital.
Efforts to stop the recovery
In the United States, there has been a sharp increase in syphilis cases in recent years.
According to data from the Centers for Disease Control and Prevention (CDC), cases increased by 80% between 2018 and 2022.
Syphilis cases in the US are increasing and reaching levels not seen since 1950
In 2022, more than 3,700 cases of congenital syphilis in newborns were reported, the agency said.
Earlier this year, the Department of Health and Human Services established the National Syphilis and Congenital Syphilis Syndrome Task Force (NSCSS) to help combat rising numbers.
The 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 also assured that the approval of this new home test will help “reverse the recent dramatic increase in sexually transmitted diseases in the United States.”
“If left untreated, syphilis can cause severe heart and brain damage and can lead to blindness, deafness and paralysis,” the FDA wrote in the press release.
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“If transmitted during pregnancy, it can result in miscarriage, lifelong health problems and infant death.”
Fox News senior medical analyst Dr. Marc Siegel told Fox News Digital that these advances could also play a role in the CDC’s new program, DOXY PEP, which aims to prevent “post-exposure prophylaxis with doxycycline against chlamydia, gonorrhea and syphilis.”
“If transmitted during pregnancy, syphilis can lead to miscarriages, lifelong health problems, and infant death.”
The program has proven to be “significantly effective in reducing clinical infections,” said New York-based physician Siegel.
Siegel described the new syphilis test as “particularly important” because “the earlier syphilis is detected or diagnosed, the better.”
The approval of the new home test will help “reverse the recent dramatic increase in sexually transmitted diseases in the United States,” the FDA said. (iStock)
Michelle Tarver, MD, PhD, acting director of the FDA’s Center for Devices and Radiological Health, wrote in a statement that advances in sexually transmitted disease testing could “give patients more information about their health in the privacy of their own home.”
“Access to home testing can help increase initial screening for syphilis, including among people who may be hesitant to see their doctor because of possible exposure to sexually transmitted infections,” she said.
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This could lead to increased laboratory testing to confirm the diagnosis, Tarver added, which in turn could intensify treatment and help contain the spread.
The FDA acknowledged that false negative results can occur, which can lead to delays in treatment and further spread of infection. (iStock)
Saphier added that with syphilis cases on the rise, “it is disappointing to see so many advanced cases of a disease that is otherwise treatable.”
“While prevention is always the best option, early diagnosis and treatment are essential not only to provide the best health care, but also to reduce the cost burden on society as a whole – because advanced disease and disability are costly,” she said.
Possible restrictions
Saphier raised some concerns about the use of home tests to detect disease, as they are “often less accurate than standardized laboratory tests.”
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“This can lead to false negative results and a person who would otherwise need treatment not receiving it,” she said.
“If someone is at high risk for syphilis infection or is showing symptoms, they should avoid the home test and talk to their doctor.”
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The FDA acknowledged that false negative results can occur, which could lead to delays in treatment.
Symptoms of congenital syphilis include sores and rashes on the skin, fever, jaundice, sneezing or runny nose, and swollen spleen and liver, according to the Mayo Clinic. (iStock)
“Test results alone should not be used to start, stop, or change treatment without consulting a healthcare professional,” the FDA wrote in the press release.
“If someone is at high risk for syphilis infection or is showing symptoms, they should avoid the home test and talk to their doctor.”
“In addition, people using this test who may have recently been exposed to syphilis should seek medical attention for treatment and evaluation, regardless of test results.”
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Symptoms of congenital syphilis include sores and rashes on the skin, fever, jaundice, sneezing or runny nose, and swollen spleen and liver, according to the Mayo Clinic website.
If the condition is left untreated, later symptoms such as hearing loss, dental problems and a saddle nose, where the bridge of the nose collapses, can occur.
