The FDA Authorized the First Home Test Kit for Chlamydia and Gonorrhea

Key Points:

• Chlamydia and gonorrhea are two of the most prevalent sexually transmitted diseases (STDs) in the United States. Untreated, they can lead to severe health problems.
• The FDA authorized a home test for chlamydia and gonorrhea, the first home STD test it has approved since the OraQuick in-home test for HIV in mid-2012.
• Expanding access to diagnostic tests may help people get faster treatment and avoid transmitting infections to others.

The United States Food and Drug Administration (FDA) has authorized a home test kit for chlamydia and gonorrhea. The kit allows people to collect their samples without visiting a doctor's office.

Other than home test kits for HIV, this is the first home test for a sexually transmitted disease (STD) to get the FDA's seal of approval, the organization said in a statement.

Adults can buy the Simple 2 test kit online without a prescription. The kits will be available over the counter in pharmacies soon.

Why are STIs so prevalent in the U.S.?

The U.S. is experiencing an epidemic of sexually transmitted infections (STIs) and STDs, according to the Centers for Disease Control and Prevention (CDC).

An estimated 2.4 million people ages 15 to 39 experienced prevalent urogenital chlamydial infections in 2018, according to a 2021 study published in the journal Sexually Transmitted Diseases. Of these, 1.1 million were men and 1.3 million were women.

Prevalent urogenital gonococcal (gonorrhea) infections in 2018 among people ages 15 to 39 totaled 209,000: 50,000 men and 155,000 women.

In 2021, roughly 1.6 million chlamydia cases and 710,151 gonorrhea cases were reported nationwide, according to estimates from the CDC.

"The COVID-19 pandemic contributed substantially by disrupting many sexual health care services," said KrisEmily McCrory, M.D., a family medicine physician at Cheshire Medical Center in Keene, New Hampshire. "Resources that typically go to STI services were redirected to the public health emergency around COVID-19, and we are just starting to recover from that."

However, STD and STI incidence rates were on the rise for years before 2020, according to CDC data. The rate of reported gonorrhea has risen by 118 percent since a historical low in 2009, according to the agency. From 2020 to 2021, the overall rates of reported gonorrhea and chlamydia increased by 4.6 percent and 4.1 percent, respectively.

Health experts have identified several contributing factors to why STI rates are rising, including:

• Antibiotic-resistant gonorrhea
• Barriers to STD and STI testing and treatment, such as stigma, poverty, housing instability and lack of medical insurance
• Changing perceptions about STDs and STIs due to improved prevention and treatment methods, such as PrEP for HIV and antibiotics for chlamydia and gonorrhea, leading some people to take fewer precautions
• Cuts to local and state STD and STI programs, including free or reduced-cost services, leading to reduced access to diagnostic tests and treatment
• Decreased condom usage
• Expanding sexual networks as more people meet up via social media and dating apps
• Lack of comprehensive sex education in schools

Chlamydia and gonorrhea, like most STDs, can be passed through vaginal, anal or oral sex. Condoms can significantly reduce transmission risk, but they won't be effective every time, often due to user error, according to 2017 CDC research.

Neither gonorrhea nor chlamydia is likely to cause long-term issues when treated early. However, unaddressed, they can lead to serious health problems, including the following:

• Erectile dysfunction (ED)
• Disseminated gonococcal infection (DGI)
• Infertility
• Ectopic pregnancy
• Pelvic inflammatory disease (PID)
• Increased risk of HIV

Both conditions are often asymptomatic, so people may be unaware they're infected for some time. Testing is vital so people can get treatment faster and protect others from infection.

Recommended

• Gonorrhea: A Hands-On Guide to This Common Infection: Since this STD often has no symptoms, it's important to understand how you can protect yourself.
• Chlamydia: The Most Successful STD in America: Early treatment can clear it up in about a week, but you need to know you have it first.
• How Chlamydia Can Cause ED: Learn how chlamydia is related to erectile dysfunction and what you can do to protect yourself.

What is the first home test for chlamydia and gonorrhea?

The new chlamydia and gonorrhea home test, called Simple 2, is manufactured by LetsGetChecked, an international virtual health company.

"The test expands accessibility by offering discretion and removing barriers such as the inability to get to a doctor's office due to cost; lack of local services, transportation or childcare; or the inability to get time off from work," said Mina Kalantari, Ph.D., the chief scientific officer at IHDLab, in Irvine, California.

As a result, people can get results quickly, potentially accelerating treatment for chlamydia or gonorrhea and reducing their chances of passing the infection on to others. At-home tests are crucial for vulnerable populations, such as adolescents and members of the LGBTQIA+ community who may face additional barriers to traditional in-office treatment.

"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., the director of the FDA's Center for Devices and Radiological Health, in a press release.

How does the first in-home test for chlamydia and gonorrhea work?

Users must initiate the test online by completing a health questionnaire to receive a home collection kit, which costs $99. The home collection kits are packaged in plain envelopes without reference to the manufacturer.

You collect your vaginal swab or urine specimen following the instructions in the collection kit. You then send the prepaid, pre-addressed return packaging. Within two to five days after the sample arrives at the lab, LetsGetChecked sends the user confidential results via the app.

What happens if the results of your chlamydia and gonorrhea test are invalid?

Healthcare professionals review all Simple 2 test results. LetsGetChecked offers a one-on-one follow-up consultation with a clinician if a test is invalid.

These appointments are separate from the test kit price and cost an additional $39. 

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Where can you find the Simple 2 test?

The Simple 2 test does not require a prescription. Currently, people can purchase the test on the LetsGetChecked website. A one-time test costs $99; people can subscribe to receive a test every three months for $69.30 per test. The test will be available in pharmacies in the future.

The Simple 2 test isn't eligible for insurance coverage, but LetsGetChecked accepts many flexible spending account (FSA) and health savings account (HAS) cards.

What should you do if your home kit test results for gonorrhea and chlamydia are positive?

LetsGetChecked offers one-on-one virtual follow-up visits with physicians, nurse practitioners and nurses for people who receive positive test results. These healthcare providers can prescribe medication and send it to your home or local pharmacy, according to the LetsGetChecked website.

The CDC recommends people who test positive notify any recent sexual partners since they may be infected, too.

After you finish a course of antibiotics, wait at least seven days before having sex to prevent transmission. Once the infection is cleared, you'll need to retest after three months because chlamydia and gonorrhea often resurface, even if both partners have received treatment.

Unlike with chickenpox, you can get reinfected with an STD or STI. You don't become immune to sexually transmitted infections. Using barrier protection such as condoms and dental dams can help prevent reinfection.

Where else can you get STD and STI testing?

"There are a few ways to get a test other than an in-home kit," Kalantari said. "If you have insurance, you can seek STI testing from a primary care physician or another provider, such as a gynecologist."

Alternatively, you can look to a public health clinic or nonprofit organization that offers free or low-cost testing and care.

"Planned Parenthood offers sliding payment scales and other options for access to these services," McCrory said. "Many college health centers also offer free or inexpensive STI testing for their students."

In some states, you can take a test at home through such clinics, then follow up virtually or in person with a provider if your results are positive or invalid.

You can find providers and other sexual health resources in your area through the CDC's Get Tested website.

The bottom line

Chlamydia and gonorrhea are preventable and treatable. However, unaddressed infections can have serious, sometimes life-threatening consequences, from erectile dysfunction to ectopic pregnancy.

The Simple 2 test offers a discreet and convenient way to access testing and care for you to test at home. Other resources, including community health centers, are available if you can't afford the test or would prefer to visit a clinic in person.