New at-Home Test Approved for Chlamydia and Gonorrhea

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Nov. 16, 2023 – People who want to be tested for the sexually transmitted diseases chlamydia and gonorrhea are now able to do so without leaving their homes.

Called Simple 2, it’s the first test approved by the FDA that uses a sample collected at home to test for an STD, other than tests for HIV. The test can be purchased over-the-counter in stores or ordered online and delivered in discreet packaging. A vaginal swab or urine sample is collected and then sent for laboratory testing using a prepaid shipping label.

The FDA issued the final needed approval on Wednesday, and the product is already for sale on the website of the manufacturer, LetsGetChecked. The listed price is $99 with free shipping for a single test kit, and the site offers a discounted subscription to receive a kit every 3 months for $69.30 per kit.

Gonorrhea cases have surged 28% since 2017, reaching 700,000 cases during 2021, CDC data show. Chlamydia has also been on the rise, up 4% from 2020 to 2021, with 1.6 million annual infections. Both chlamydia and gonorrhea are transmitted by having sex, including oral sex, without a condom and are especially common in people under the age of 25.

Oftentimes, gonorrhea and chlamydia don’t have symptoms. But signs can include vaginal or penal discharge or a burning sensation while peeing that can be mistaken for other conditions, so testing is important, according to CDC fact sheets. 

The conditions affect both men and women and can be cured with medication. But women who don’t get treatment for chlamydia are at risk of permanent damage to their reproductive systems. Gonorrhea can lead to pelvic inflammatory disease in women, which increases the risk of infertility. Men who are not treated can experience infertility as well. Both gonorrhea and chlamydia can be passed from a pregnant person to an unborn baby.

Previously, tests for the two STDs required that samples be taken at a health care location such as a doctor’s office. The Simple 2 test results can be retrieved online, and a health care provider will reach out to people whose tests are positive or invalid. Results are typically received in 2 to 5 days, according to a press release from LetsGetChecked, which also offers treatment services.

“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, MD, JD, 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.”