The first at-home, over-the-counter antibody test for syphilis received marketing authorization from the U.S. Food and Drug Administration (FDA) on Friday.
Traditionally, syphilis is detected by a health care provider using a blood test or by testing fluid from a syphilis sore.
The FDA said the test offers a new option for people who might be unable or reluctant to visit a doctor to get tested.
Additionally, growing number of cases are in babies born to untreated moms, known as congenital syphilis.
In 2022, 3,755 babies were born with syphilis in the U.S., an increase from the 1,325 cases among babies in 2019.
The U.S. approved the marketing of the first syphilis antibody test that could be done at home and without a prescription. s. Friday, the Food and Drug Administration (FDA).
This refers to the biotechnology business NOWDiagnostics, Inc. , which produces the test, is now authorized to market it.
Traditionally, a medical professional would test blood or fluid from a syphilis sore to determine the presence of syphilis.
First To Know, a new test, on the other hand, uses a drop of blood to provide a preliminary indication that a person may have syphilis. Results can be obtained in approximately 15 minutes. A medical professional must validate the results.
For those who may be unable or unwilling to see a doctor for testing, the test, according to the FDA, provides a new option.
Dr. Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health, stated in a statement that “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 may result in more laboratory testing to confirm the diagnosis, which may lead to more aggressive treatment and a slower rate of infection spread. “.
According to the company, which spoke with ABC News, a box containing one test will retail for $29.98 and be offered at major retailers in the fall of 2024.
In comparison to three FDA-approved laboratory tests, the test was able to correctly identify 99.5% of negative specimens and 93.4 percent of positive specimens in a clinical study involving 1,270 participants, according to the company.
“To get this product on the market, our fantastic team put in countless hours of work. The CEO of NOWDiagnostics, Rob Weigle, told ABC News in a statement that “They deserve all the credit.”. The ability for anyone to test themselves in the comfort of their own home makes this straightforward, first-of-its-kind screening test a valuable tool in the fight to stop the epidemic and lower syphilis rates across the nation. “.
In excess of 50% of cases, there are no symptoms. Consider taking this test if you think you may have been exposed or have had unprotected sex with someone and are unsure of their sexual background “.
Antibiotics are a treatment option for the sexually transmitted disease syphilis. But according to the Centers for Disease Control and Prevention (CDC), if left untreated, it can result in major health issues like blindness, hearing loss, muscle weakness caused by nerve damage, internal organ damage, and even death.
The number of syphilis cases in the U.S. has dramatically increased. s. The Centers for Disease Control and Prevention (CDC) has reported a nearly 80 percent increase in cases from over 113,000 in 2018 to over 203,000 in 2022.
Congenital syphilis, which affects babies born to untreated mothers, is another condition that is becoming more common. 3,755 infants born in the United States in 2022 had syphilis. S. higher than the 1,325 cases among infants in 2019.
