American Sexual
Health Association

A Step Forward for STI Testing: FDA Approves an At-Home Testing Option

Package in a mailbox

For the first time, the Food and Drug Administration (FDA) has given market authorization to an at-home test for chlamydia and gonorrhea—the Simple 2 test from LetsGetChecked. While there are FDA-approved home tests for HIV (including one that gives rapid results), this is the first FDA-authorized STI test with at-home sample collection.

Home tests are an important tool in fighting the rising rates of STIs. They are easy to use and for some, it can more convenient than going to a health care provider or an STI clinic. Some experts hope that FDA authorization will boost people’s confidence in home-collected STI tests and increase their use.

What is the Simple 2 test?

Produced by LetsGetChecked, the Simple 2 test can be used by people with penises or vaginas to check for genital chlamydia or gonorrhea infection. The test can be bought online without a prescription for $99. For people who want to screen more often, the company offers subscription plans that can lower the price of each test. While not covered by insurance, tests can be paid for using Flexible Spending Accounts (FSA) and Health Savings Accounts (HSA).

How does home collection work?

Users register with LetsGetChecked and receive a home collection kit by mail. They can then collect a sample of their urine and/or vaginal secretions. Unlike the home COVID tests that most people are familiar with, the results aren’t available at home. Rather, the user sends the collected samples to a lab for analysis and results are usually available within a few days. People who test negative will get their results online. If the test is positive or there is something wrong with the sample, the company will connect the user to a health care provider for follow up, including treatment if necessary.

The Simple 2 test doesn’t check for possible chlamydia and gonorrhea infections of the throat or the anus. People who may have been exposed to these STIs through oral or anal sex should talk to a health care provider.

Chlamydia and Gonorrhea—Common and Treatable

Chlamydia and gonorrhea are the two most common bacterial STIs in the United States. There were over 1.7 million cases of chlamydia and 700,000 cases of gonorrhea reported to the CDC in 2021. There are likely many more cases each year that go undiagnosed because people who are infected often have no symptoms. Bacterial STIs can be cured with antibiotics but if left untreated they can lead to health issues including pelvic inflammatory disease (PID) and infertility.

How is this test different?

Simple 2 isn’t the first STI test on the market to allow for home collection. There are other test kits available online and even on pharmacy shelves. Public health agencies around the country also offer home tests kits, often for free. These tests, however, haven’t gotten FDA authorization.

Before granting this authorization, the FDA validated that the lab processes LetsGetChecked uses to check for chlamydia and gonorrhea worked specifically when using samples collected through the Simple 2 home collection kit. It also looked at data the company provided that showed consumers could safely use the kit, that they understood the results, and that they knew what to do next based on those results.

The question now is whether the FDA will want greater oversight of all home tests. The agency recently put out a draft policy about this for public review. Now that one STI test has gotten authorization, it may be easier for other companies to do the same.

Speaking to NBC News, Dr. Leandro Mena, director of the Division of STD Prevention at the Centers for Disease Control and Prevention, said self-testing provides “a tremendous opportunity to empower people to control when, where and how they get tested, and how they learn about their test result, so they can get appropriate treatment for these STIs.”

And that is key—people should have options to when and where they want. For those who aren’t comfortable collecting their own samples, there are of course still many in-person testing options.

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