At-Home Testing for Chlamydia and Gonorrhea
Sexually transmitted infections (STIs), particularly chlamydia and gonorrhea, continue to be major public health concerns in the US. In 2022, reported rates were 495.0 and 194.4 per 100 000 people, respectively.
If left untreated, these diseases can lead to long-term sequelae such as infertility, increased HIV risk, and other adverse outcomes. Also, Neisseria gonorrhoeae has developed resistance to all previously used antibiotics. Therefore, detection and treatment are essential countermeasures to decrease infection rates and prevent resistance to newer antibiotics.
The US FDA recently granted the first marketing authorization of the LetsGetChecked’s Simple 2 diagnostic test system. The complete program includes patient-initiated test ordering, a home collection kit, result receipt, and linkage to some health services.
A person can order the test online, collect urine or a vaginal swab at home, and send it to LetsGetChecked’s designated laboratory. Testing is performed on a Hologic Panther instrument using Hologic’s Aptima Combo 2 Assay, which utilizes nucleic acid amplification.
Results are provided in 2 to 5 days with a follow-up from a clinician for positive or invalid test results. The ordering person can request a virtual consultation for an additional fee. If the chlamydia test result is positive, oral treatment can be sent to the home.
Simple 2 is authorized for ages 18 years or older. The LetsGetChecked website offers the test for $99 and a virtual consultation for $39. Reimbursement is possible through flexible spending or health savings accounts.
A positive gonorrhea test result requires a health care visit elsewhere, for an intramuscular injecton of ceftriaxone, which is recommended treatment for uncomplicated cases.
STI self-testing in the privacy of one’s home has several advantages over traditional diagnosis. Self-testing can reach people who distrust or avoid health care systems due to STI stigma, embarrassment, or questions about sexual behavior. Collecting a sample at home is more convenient because it eliminates the need for transportation and a clinic appointment. If positive, the correct antibiotic can be sent to the home.
References
Kersh EN, Mena LA. At-Home Diagnostics Solutions for Chlamydia and Gonorrhea. JAMA. Published online April 29, 2024. doi:10.1001/
Sexually transmitted infections surveillance, 2022: national overview of STIs, 2022. Centers for Disease Control and Prevention. Accessed February 16, 2024. https://www.cdc.gov/std/statistics/2022/overview.htm
FDA grants marketing authorization of first test for chlamydia and gonorrhea with at-home sample collection. US Food and Drug Administration. November 15, 2023. Accessed December 20, 2023. https://www.fda.gov/news-events/press-announcements/fda-grants-marketing-authorization-first-test-chlamydia-and-gonorrhea-home-sample-collection
Workowski KA, Bachmann LH, Chan PA, et al. Sexually transmitted infections treatment guidelines, 2021. MMWR Recomm Rep. 2021;70(4):1-187. doi:10.15585/mmwr.rr7004a1
Wilson E, Free C, Morris TP, et al. Internet-accessed sexually transmitted infection (e-STI) testing and results service: a randomised, single-blind, controlled trial. PLoS Med. 2017;14(12):e1002479. doi:10.1371/journal.pmed.1002479
STD testing, lab results & treatment from home. LetsGetChecked. Accessed December 20, 2023. https://www.letsgetchecked.com/home-std-test
