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US Food and Drug Administration Allowed First at-home drug-free test for syphilis on Friday.
So far, people who suspect that they have sexually transmitted infections He had to go to the doctor for an examination. Biotech company NOWDiagnostics' new test takes just 15 minutes and a single drop of blood to determine if a user has syphilis.
However, this test is the first step if someone suspects they have the disease, the FDA says. If you test positive at home, you are advised to go to a doctor for further testing to confirm the diagnosis.
The test will be available in the second half of 2024 and will cost $29.98, the company said.
“We continue to see tests, particularly tests for sexually transmitted infections, that can provide patients with more information about their health from the privacy of their homes,” said Dr. Michelle Tarver, acting director of the FDA's Center for Devices and Radiology. Health, by News release. “Access to at-home tests can help increase early detection of syphilis, including among individuals who neglect to see their health care providers about exposure to sexually transmitted infections. This will lead to increased laboratory testing to confirm the diagnosis, which will increase treatment and reduce the spread of infection.”
It was syphilis. Close to removal In the year in the 1990s, but the number of people testing positive in the United States has increased dramatically over the past few decades.
Issues escalated. 80% between 2018 and 2022, including newborns, according to the latest data from the US Centers for Disease Control and Prevention. There were more cases that occurred only in newborns In 2022, it will be 10 times more Ten years ago. In the year By 2022, more than 207,000 total cases of syphilis will be reported. The highest number Since the 1950s, according to the CDC.
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Syphilis a Bacterial infection It may seem small at first. First of all, people may experience sores on their genitals or anus. Normally, the wound can heal on its own, but it is still important to be treated with antibiotics to prevent the infection from getting worse. In the final stage, syphilis can cause blindness, deafness, brain and heart damage if not treated. A pregnant woman who becomes pregnant may miscarry or pass the infection on to the baby. With lifelong medical issues.
The new test received FDA approval after the company presented data from clinical trials. It also showed that the tests were easy for people without medical training to use.
NOWDiagnostics said it hopes the test will have a significant impact on public health and improve access to timely diagnosis and treatment, especially for the underserved.