FDA Approves At-Home Chlamydia, Gonorrhea Test Kit

The new FDA-approved test will enable more effective detection of chlamydia and gonorrhea, the most common bacterial sexually transmitted infections (STI) in the United States, which have been steadily on the rise.

The Simple 2 Test, developed by LetsGetChecked, uses self-collected vaginal swabs or urine specimens to detect the presence of the bacteria which cause chlamydia and gonorrhea.

It is intended for use in adult patients 18 years and older and will be available without a prescription. It is the first FDA-authorized test with at-home sample collection for any sexually transmitted disease other than HIV.

The user activates the collection kit online and fills out a health questionnaire that a healthcare provider will evaluate. Using the provided collection kit, the individual collects the specimen and sends it to the designated laboratory for testing. Results are delivered online, with follow-up from a healthcare provider if they are positive or invalid.

"This authorization marks an important public health milestone, giving patients more information about their health from the privacy of their own home," said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, in a statement. "We are eager to continue supporting greater consumer access to diagnostic tests, which helps further our goal of bringing more health care into the home."

The risks of using The Simple 2 Test are mainly the possibility of false positive and false negative test results. False negative test results can lead to treatment delays, progression to disseminated disease, and spread of infection to other people. Meanwhile, false positives may result in unnecessary treatment and psychological distress.

Chlamydia and gonorrhea are the first and second most common bacterial STIs in the U.S., with an estimated 1.6 million and 700,000 cases in 2021, respectively. If left untreated, it may cause serious health complications, including infertility.

Both infections can be easily treated with antibiotics. However, along with syphilis, they are becoming increasingly resistant to multiple drugs, according to the World Health Organization (WHO). A strain of antibiotic-resistant gonorrhea was also detected in the U.S.

What are the symptoms of gonorrhea and chlamydia?

While most men with gonorrhea are asymptomatic, some may experience white, yellow, or green discharge from the penis. In some cases, the infection may cause testicular or scrotal pain.

In women, symptoms are usually mild and unspecific, such as increased vaginal discharge or vaginal bleeding between periods.

Chlamydia may cause abnormal vaginal discharge or discharge from the penis and a burning sensation when peeing. The infection can also spread to the rectum, causing rectal pain, discharge, and bleeding.

The new at-home test for common STIs may help to reduce the spread of chlamydia and gonorrhea and prevent severe complications caused by these conditions.