The Double-Edged Sword of Home STI Testing

They offer convenience and privacy, but federal regulations could slow down adoption

Note: The terms “sexually transmitted infection,” or “STI,” and “sexually transmitted disease,” or “STD,” are used interchangeably in this article, based on usage by the original sources.

Sexually transmitted infections continue to rise. Reported cases of the sexually transmitted infections (STIs) chlamydia, gonorrhea, and syphilis all increased between 2020 and 2021 – reaching a total of more than 2.5 million reported cases – according to the Centers for Disease Control and Prevention.¹

Because the number of infections and the need for screening have increased, at-home test kits for STDs such as HIV, chlamydia, and gonorrhea have grown in popularity.² Visiting a clinic remains the best choice for screening, but if privacy concerns, inconvenience, or limited access to a provider are issues, then online and home-to-lab STD screening tests may be the best option.

The COVID pandemic boosted at-home testing, given the unprecedented availability of new rapid test formats for COVID-19 under emergency use authorization.³ Their introduction into the U.S. market was a major development in the diagnostic testing landscape. The advantages are accessibility, convenience, speed and reduction in needed healthcare workers, facilities and personal protective equipment.

But at-home testing for STIs was a market ripe for growth even had the pandemic never occurred. Research has shown that social stigma creates a major barrier to testing for sexually transmitted infections.⁴ But in recent years, at-home test kits for STIs—which allow an individual to collect a sample at home instead of at a clinic—have become more common, making testing more accessible and appealing to individuals who avoid going to a clinic due to stigma or shame.

At-home testing for STIs was a market ripe for growth even had the pandemic never occurred.

Some testing programs have implemented specimen self-collection at home followed by testing in a distant laboratory.⁵ Many such programs are adopting a telehealth approach in which the patient first interacts with the healthcare provider, who selects and orders tests, answers questions, then facilitates shipping of collection kits to the home or arranges pick-up. The patient collects the specimen, which then goes to a central laboratory. This is particularly popular for gonorrhea and chlamydia testing by laboratory- based NAAT (nucleic acid amplification test), using urine or self-collected swab specimens.

Convenience or Compromise?

The convenience of at-home tests is well-recognized, but so are some potential drawbacks. UAB Medicine obstetrician and gynecologist Shweta Patel, MD, believes home testing can be a good option in certain cases.⁶ Some people may have limited transportation and can’t get to a clinic easily, says Dr. Patel in an article on the University of Alabama Birmingham Medicine website. For them, kits offer convenience. “These screenings do not require a pelvic examination, therefore people with medical conditions that can make pelvic exams difficult have the option of testing at home.” In addition, home tests offer privacy for those who are reluctant to visit their doctor or go to a screening clinic.

But Dr. Patel is concerned that people testing at home may failing to collect good samples. Most tests for chlamydia and gonorrhea require vaginal swabs or urine samples, she points out. “As a provider, knowing from my practice what is sometimes needed to get an adequate swab sample, I do wonder if people are accomplishing that task at home.”

Another potential drawback with home STD testing is how patients respond to results after they receive them, says Dr. Patel. A positive result can be alarming and confusing, so patients may not correctly interpret their test results. Although some home testing labs and websites offer advice by phone or provide links to local doctors for treatment, overall, they do not give the same level of post-diagnosis care that in-person visits provide.

In addition, home testing can diminish healthcare professionals’ ability to connect with patients on preventative care, according to Susan Milstein, PhD, M.A., CPH, MCHES, founder of Milstein Health Consulting.⁷ Working with patients in person provides clinicians and sexual health educators an avenue to share information with patients so they can remain STI-free.

Innovation vs. Oversight

The Food & Drug Administration’s involvement in at-home testing will be crucial to its development. Until November 2023, the only tests that were authorized for home use by the FDA were those that test for HIV.⁸ (In November, the FDA granted marketing authorization to LetsGetChecked for the Simple 2 Test, making it the first diagnostic test for chlamydia and gonorrhea with at-home sample collection to be granted marketing authorization.⁹)

In September 2023, the FDA announced a proposed crackdown on laboratory developed tests, or LDTs, which are those designed, manufactured and used within a single clinical laboratory that meets certain laboratory requirements.¹⁰ The proposed rule would make explicit that in vitro diagnostic products are devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer is a laboratory. The agency intends to provide greater oversight of LDTs through a phaseout of its general enforcement discretion approach to LDTs.

Not everyone was pleased with the agency’s proposal, including NASTAD, which represents public health officials who administer HIV and hepatitis programs in the U.S.

In a letter to FDA Commissioner Robert M. Califf, NASTAD Executive Director Stephen Lee, M.D., MBA, DHSM, wrote that if FDA’s proposal were to be adopted, “public health departments would be unable to continue to offer [in vitro diagnostics] as LDTs for HIV, viral hepatitis, STIs, and other sexual health concerns, thereby eliminating access to critical testing resources and delaying identification of infection, engagement in treatment, undercutting public health surveillance, and, most crucially, exacerbating health inequities.”

Public comments were accepted up to Dec. 4, 2023. A final rule has yet to be announced.

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