OTC Syphilis Test
The FDA just approved the First to Know In home Syphilis test manufactured by NowDiagnostics. With a single drop of blood, the test kit in fifteen minutes can detect syphilis infection but the FDA recommend follow up laboratory testing through a health care provider for a confirmed and precise diagnosis. ““FDA granting De Novo authorization of our First To Know® Syphilis Test could not have come at a more important juncture in our country’s efforts to slow the rise of syphilis,” said Rob Weigle, CEO of NOWDx. “Testing is one of the most important tools we have in preventing the spread of sexually transmitted infections, and for the first time ever, consumers now have a fast and simple syphilis test that can be performed in the privacy of one’s home, with a result in minutes.” Syphilis is a sexually transmitted infection (STI) caused by the bacterium Treponema pallidum. Despite being one of the oldest known STIs, dating back centuries, syphilis remains a significant public health concern not only in the US but also worldwide. Its insidious nature and potentially severe complications make early detection and treatment crucial. FDA’s Acting Director for Center for Devices and Radionlogical Health Michelle Tarver, MD PhD remarked, “We continue to see advancements in tests, particularly tests for sexually transmitted infections, which 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. This can lead to increased lab testing to confirm diagnosis, which can result in increased treatment and reduction in the spread of infection.” In the US, the data from CDC (Center for Disease Control and Prevention) revealed that Syphilis cases increased by 80% to over 207,000 between 2018 and 2022. More than 3,700 cases of congenital Syphilis were documented among newborns in 2022 which is ten times the number diagnosed in 2012.
From NOWDiagnostics here’s what you need to know on their OTC in home Syphilis Test kit: “Syphilis in The First To Know® Syphilis Test is a patented buffer-less lateral flow device that provides a qualitative rapid membrane immunochromatographic assay for detecting Treponema pallidum (syphilis) antibodies in human whole blood (capillary) from individuals suspected of having a syphilis infection. In a clinical study of 1,270 people, the NPA (negative percent agreement) was 99.5%, meaning it correctly identified 99.5% of negative specimens; the PPA (positive percent agreement) was 93.4%, meaning it correctly identified 93.4% of positive specimens when compared to three FDA cleared laboratory tests. First To Know® Syphilis Tests are expected to be available at major national retailers and online in the second half of 2024.”
So what are the early signs of the presence of Syphilis: One thing to note though, Syphilis progresses through distinct stages, each with characteristic symptoms:
Primary Syphilis:
This stage is marked by the appearance of a painless sore, known as a chancre, at the site of infection (usually the genitals, anus, or mouth).
The chancre appears between 10 to 90 days after exposure and heals on its own within a few weeks.
Secondary Syphilis:
If untreated, the infection progresses to this stage, characterized by skin rashes (often on the palms of the hands and soles of the feet), mucous membrane lesions, and flu-like symptoms.
These symptoms may appear weeks to months after the chancre heals and can be mild or severe.
Latent Syphilis:
This stage follows secondary syphilis and is asymptomatic.
The bacterium remains in the body, potentially for years, without causing symptoms. However, the infection can still be detected through blood tests.
Tertiary Syphilis:
If untreated, syphilis can progress to this stage years or even decades after the initial infection.
It can cause severe damage to various organs, including the heart, brain, nerves, eyes, and bones. This can lead to life-threatening complications.
And this is where the OTC in home Syphilis Test comes in handy because it’s a rapid Syphilis test that gives a person a general idea on whether there’s a presence of Syphilis infection, but it’s important to have a laboratory follow up for a more accurate confirmation. Early diagnosis and treatment reduces the risk of spreading the infection to sexual partners, and treatment an early stage is important to prevent progression to severe stages, as for pregnant women, early detection is essential to prevent congenital Syphilis.
