Sexually Transmitted Infections Collection Test In The Comfort of Your Own Home

McKayla Duesler, PharmD, Welia Health

Sexually transmitted infections (STIs) are a growing concern for many patients and healthcare professionals. The Centers for Disease Control and Prevention (CDC) deems STIs as an epidemic and it is estimated that there were 1.6 million cases of chlamydia and 600,000 or more cases of gonorrhea in 2022 alone. These numbers provide a strong need for improving access and care for STI testing and treatment. This need is the main reason a company called LetsGetChecked developed an over-the-counter (OTC) at-home collection test called Simple 2™. Other than human immunodeficiency virus (HIV) home test kits, Simple 2TM will be the first ever Food and Drug Administration (FDA) approved at-home collection test for common STIs. The FDA approved this test in November 2023 under the De Novo premarket pathway for low-to moderate-risk devices. 

The Simple 2™ test can be ordered online, without a prescription, at the LetsGetChecked webpage for $99. The test is available for patients 18 years or older and includes a vaginal swab or urine sample, free shipping, and discreet packaging. When the sample is collected, it can be mailed back to a CLIA and CAP-certified laboratory by LetsGetChecked to be analyzed. Results are delivered to the patient online within 2-5 days. Patients then have the option to set up a virtual consultation with a provider to review the results and obtain treatment if indicated.

The risks of the collection kits remain minimal but could include false positive results which can lead to unnecessary treatment, and false negative results which can delay treatment or increase spread of disease. Stated in an online FDA news release, the authorization of this product led the FDA to establish new special controls related to labeling and performance testing which could pave the pathway for other STI at-home sample collections. In general these new at-home collection kits are improving access and comfortability with STI testing allowing for the opportunity to treat more patients. The future of STI treatment is changing for the better and as healthcare technology progresses, more OTC sample collection tests can be expected. 

References:

  1. FDA News Release: FDA Grants Marketing Authorization of First Test for Chlamydia and Gonorrhea with at-home Sample Collection. U.S. Food & Drug Administration. Published November 15, 2023. Accessed December 26, 2023. https://www.fda.gov/news-events/press-announcements/fda-grants-marketing-authorization-first-test-chlamydia-and-gonorrhea-home-sample-collection. 
  2. Ferruggia K. FDA Approves At-Home Collection System to Test for Chlamydia and Gonorrhea. Pharmacy Times. Published November 16, 2023. Accessed December 26, 2023. https://www.pharmacytimes.com/view/fda-approves-at-home-collection-system-to-test-for-chlamydia-and-gonorrhea. 
  3. Simple 2. LetsGetChecked. Accessed December 26, 2023. https://www.letsgetchecked.com/simple-std-test/. 
  4. National overview of STIs, 2022. Sexually Transmitted Infections Surveillance, 2022. January 30, 2024. Accessed February 12, 2024. https://www.cdc.gov/std/statistics/2022/overview.htm