FDA Approves Home Test for Chlamydia and Gonorrhea

December 3, 2023

2 min read

On November 15th, 2023, the Food and Drug Administration (FDA) approved a home test for chlamydia and gonorrhea. The authorization allows LetsGetChecked to begin marketing for the Simple 2 Test.

The Simple 2 Test kit can be purchased over-the-counter for prices currently ranging from $59 to $99, allowing people to accurately test themselves from the privacy and comfort of their own homes. Results from the test kit are received a week after testing. The FDA hopes that this new testing option for chlamydia and gonorrhea will help contain the sexually transmitted infection (STI) epidemic.

Why Does This Matter?

Before now, there have been no at-home chlamydia and gonorrhea testing kits available and this is the first one to be approved other than the HIV test kit. The only available testing options before now have been at the doctor’s office.

This new authorization will increase the availability and flexibility of STI testing for the public, likely increasing testing across the country and making STI testing more accessible for everyone – especially those living in rural areas far from a doctor’s office or testing facility.

The increased availability of STI testing should result in more people testing themselves and hopefully curbing the STI epidemic.

How Common Are Gonorrhea and Chlamydia?

The CDC reported an estimated 700,000 cases of gonorrhea and 1.6 million cases of chlamydia in 2021.
In 2020, the World Health Organization (WHO) estimated 82 million new cases of gonorrhea and 129 million new cases of chlamydia.

Unfortunately, the prevalence of both STIs has continued to climb over the past two decades, especially during the pandemic. However, experts believe that increasing the accessibility of testing will help prevent the spread of these infections.

What Are Chlamydia and Gonorrhea?

Chlamydia and gonorrhea are caused by bacterial infections. Although HPV is the most common STI in the U.S., chlamydia and gonorrhea are the most commonly reported STIs in the country.

These two STIs cause painful urination and bleeding between menstrual periods. If left untreated, gonorrhea and chlamydia can result in severe health complications including infertility. However, they are easily treated with antibiotics, which is why testing is so vital.

How Does the Test Work?

The at-home Simple 2 chlamydia and gonorrhea test is available for people 18 years and older. The test involves a urine sample or vaginal swab and includes a sample collection kit. It can be delivered to a person’s place of residence and includes a prepaid label to easily mail in the sample. Finally, the sample is analyzed at LetsGetChecked’s lab and results should be returned online within a week, but as soon as 2 to 5 days after testing.

The results will also include suggested treatment and consolation, depending on the results of the test.

Takeaway

The new FDA approval of the Simple 2 test for chlamydia and gonorrhea will increase STI testing accessibility and may curb the STI epidemic. Amid other new efforts against the STI epidemic, including the new CDC recommendation for doxycycline as a morning after pill for men having sex with men, this may mark a turning point in the fight against STIs.

Sources