United States: In the latest report by the US Food and Drug Administration, permission was granted to bring the first-ever at-home syphilis test to the market.
More about the news
As per the reports, the test is made by NOWDiagnostics in Arkansas, which could detect antibodies for Treponema pallidum (syphilis)
The test would not even need a prescription and a mere fifteen minutes to administer using only a drop of blood, which the company said was “like a finger prick,” as Fox News reported.
Moreover, it is said that the result comes as positive for those currently suffering from syphilis infection, along with those who have been previously diagnosed, even if they had been treated successfully.
Therefore, as per the FDA, the findings of tests would not be enough to find syphilis in an individual, and an additional test must be performed to ensure a proper diagnosis.
More about the study
According to a study examining 1,270 people, the product was “easy to use,” as showed a release by NOWDiagnostics.
The results revealed that the test has an efficacy of 99.5 percent in identifying negative cases and 93 percent for a positive diagnosis.
Moreover, as NOWDiagnostics CEO Rob Weigle said, “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,” as the Fox News reported.
“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,” he continued.
Moreover, the medical contributor of Fox News, Dr. Nicole Saphier said that she found at-home tests to be “great,” becuase it could help in more testing without having to visit a doctor.
“Anything that increases access to health information while also being cost-effective is a positive step in the right direction,” She added.
Efforts to control syphilis cases
With the rising cases of syphilis cases all over the US in the past few years, the cases showed a jump of 80 percent from 2018 to 2022, as identified by the data from the Centers for Disease Control and Prevention (CDC).
The report showed that in 2022, among newborns, 3,700 cases of syphilis were reported, as FOX News reported.
This year, the Department of Health and Human Services formed the National Syphilis and Congenital Syphilis Syndemic (NSCSS) Federal Task Force to help in combatting the rising cases.
Along with that, the FDA also said the approval of this newly introduced at-home test would 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 added.
Moreover, “When transmitted during pregnancy, it can cause miscarriage, lifelong medical issues, and infant death.”
According to senior medical analyst Dr. Marc Siegel, the step would play an important role in the CDC’s new program, DOXY PEP, which aims to prevent “post-exposure prophylaxis with doxycycline for chlamydia, gonorrhea, and syphilis.”