FDA Authorized the First At-Home Test Kit for Chlamydia and Gonorrhea

Fact checked by Nick Blackmer

Key Takeaways

• The FDA granted marketing authorization for the first at-home test for chlamydia and gonorrhea.

• The test, called Simple 2, is the first FDA-authorized at-home test kit for STIs other than HIV.

• Experts say the authorization expands public accessibility and flexibility for testing STIs, particularly benefiting communities that have low access to sexual health clinics.

The Food and Drug Administration (FDA) authorized the first at-home sample-collection test for chlamydia and gonorrhea. Adults can now buy the test over the counter (OTC) without a doctor’s prescription.

The test, called Simple 2, is made by the virtual health company LetsGetChecked.

Previously, the only approved tests for chlamydia and gonorrhea required samples to be collected on-site, such as at a provider’s office. According to the FDA, Simple 2 is the first test with at-home sample collection for sexually transmitted infections (STIs) other than HIV.

Chlamydia and gonorrhea are the two most common STIs in the United States. Both of these infections are increasing, with an estimated 1.6 million chlamydia cases and more than 700,000 gonorrhea cases reported in 2021, according to the Centers for Disease Control and Prevention (CDC).

These STIs are easily treatable, but people don’t always know they are infected. If left untreated, both STIs can have severe health consequences, including infertility.

Making STI testing more accessible can help patients get their results faster and seek treatment, the FDA said.

“This authorization marks an important public health milestone, giving patients more information about their health from the privacy of their own home,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a press release. “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.”

Learn More: Where to Get STI Testing and Treatment

What Does This Mean for STI Testing?

The marketing authorization for Simple 2 will broaden public access and flexibility for STI testing, said Monte Swarup, MD, FACOG, a board-certified OB/GYN in Chandler, AZ and the founder of Vaginal Health Hub.

This is especially important, he said, for people living in rural areas that don’t have healthcare providers, telehealth services, or accessible clinics nearby.

“The FDA approval gives the public the ability to collect their specimens from home and provides greater accessibility and flexibility,” Swarup said. “This expands the potential for home health care.”

Learn More: Best At-Home Syphilis Testing in 2023

How Does the Simple 2 Test Work?

For the Simple 2 test, a patient self-collects their specimen within the safety, convenience, and privacy of their own home, Robert Mordkin, MD, chief medical officer of LetsGetChecked, told Verywell.

People with a vagina take a vaginal swab and those with a penis give a urine sample, Mordkin said. Once the sample is collected, a patient sends their specimen to a designated LetsGetChecked lab for testing. The kit comes with a prepaid, pre-addressed packet for overnight shipping.

“The specimen is processed and analyzed on FDA-approved equipment, and the results are quickly provided directly to the individual via their LetsGetChecked app,” said Mordkin.

Once their specimen has been shipped out, a patient can expect to get results within two to five days.

For positive results or invalid tests, the company offers patients follow-up support and treatment discussions with their team of physicians, nurse practitioners, and nurses. However, the follow-up consultations and prescribed medications are not included in the cost of the test.

Learn More: Where Can I Get an STD Test?

How Much Does Simple 2 Cost?

You can order a Simple 2 test online through the LetsGetChecked website or app.

Before you can get a test, you need to fill out a brief health questionnaire. It will be quickly reviewed by the company’s medical team so that a “prescription” for the test can be generated. “There is no need to get a prescription from an outside source," Mordkin said.

A single Simple 2 test kit costs $99 out-of-pocket. You can also subscribe and pay $69.30 to receive a test every 3 months, $79.20 for every 6 months, or $84.15 for every 12 months.

Currently, the Simple 2 test is not eligible for insurance coverage. However, Mordkin said that the company does accept many Flexible Spending Account (FSA) and Health Savings Account (HSA) cards.

“We do not accept insurance at this time. We work to keep our tests as affordable as possible, and our test costs are generally lower than the costs incurred from a trip to a healthcare provider,” Mordkin said.

Out-of-pocket costs for STI tests given at home or through a health provider can range from $50 to more than $300, depending on the company and how many diseases the product tests for.

While many insurance plans will cover the cost of preventive STI screening and the healthcare provider’s visit fee, the cost to the patient will depend on their plan. Insurers may pay for one STI test per year, they may cover some of the cost and require a co-pay, or they may cover testing for some STIs but not others.

Learn More: What You Should Know About Online STD Testing

Other Ways to Get STI Testing

You can also get tested for chlamydia and gonorrhea at a healthcare provider’s office, a community health clinic, or your local health department. In some states, you might have the option of an online visit with a provider along with at-home testing.

Many local clinics and Planned Parenthood health centers offer inexpensive or free STI testing. You can call ahead to learn if you are eligible for free testing.

“STI testing is available and may be more cost-effective if health insurance covers testing via your physician or more cost-effective through the county health department,” said Taylor Nelson, DO, an assistant professor of clinical medicine at the University of Missouri School of Medicine and Medical Director, MU Infection Control, at MU Health Care, told Verywell.

If you’re not sure where to get STI testing, your state’s public health department and your provider’s office are two places to ask first.

What This Means For You

You can take an at-home test for chlamydia and gonorrhea without a prescription requirement. You’ll need to pay out-of-pocket for the test and any follow-up care and treatment you get from LetsGetChecked.

The Simple 2 test may give a false negative test, the FDA said. If you’re exposed to a person with gonorrhea or chlamydia, you should see a healthcare provider for antibiotic treatment and further care, regardless of the test result.

Read Next: 8 At-Home STD Tests for 2023

Read the original article on Verywell Health.