NOV 16, 2023 1:26 PM PST

First At-Home Chlamydia, Gonorrhea Test Approved by FDA as Cases Keep Rising

WRITTEN BY: Carmen Leitch

Recent statistics show that the incidence of sexually transmitted infections (STIs) continues to rise. In 2021 alone, over 2.5 million cases of chlamydia, gonorrhea, and syphilis were reported. The latest data from the Centers for Disease Control and Prevention (CDC) has shown that in the case of chlamydia, recent gains gave been reversed, and a 4.1 percent increase in cases from 2020 t0 2021 shows that rates are returning to pre-pandemic levels. The incidence of gonorrhea cases has also risen by 28 percent since 2017.

Image credit: Pixabay

Ensuring that people get tested for STIs and treated (with antibiotics) if they are infected will be incredibly important if we are going to get a handle on this public health problem. A new at-home test has now been approved by the US Food and Drug Administration (FDA), and it could help with that effort.

The test is called Simple 2 Test, it is made by a company called LetsGetChecked. It will be available at pharmacies over-the-counter, and is also available from the company online for $99. People can take a sample by themselves at home and them send it in for testing. Depending on the individual, the sample will either be a vaginal swab or urine specimen. Consumers will also have to complete a questionnaire online.

Once the sample has arrived at the lab, the test checks for the presence of Chlamydia trachomatis and Neisseria gonorrhoeae bacteria, which are the causes of chlamydia and gonorrhea, respectively.

Right now, the company says that test results will be returned to the consumer online within two to five days of receiving the sample. Health care providers will also follow up with any consumers who receive a positive result from their test.

This is the first test that can be taken at home for any STI except HIV.

"This authorization marks an important public health milestone, giving patients more information about their health from the privacy of their own home," said Dr. Jeff Shuren, director of the Center for Devices and Radiological Health at the FDA.

Sources: Centers for Disease Control and Prevention, Food and Drug Administration

About the Author
Bachelor's (BA/BS/Other)
Experienced research scientist and technical expert with authorships on over 30 peer-reviewed publications, traveler to over 70 countries, published photographer and internationally-exhibited painter, volunteer trained in disaster-response, CPR and DV counseling.
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