At-home STI testing: It removes some barriers, but raises concerns too

If you Google “at-home STI tests,” you’ll find plenty of entries. It’s true that such tests can remove some barriers to STI testing, and that’s a good thing. But researchers agree they should be considered as supplements to – not replacements for -- in-office testing and consultation with a physician.

When the COVID-19 pandemic arrived, clinic-based testing around the world took a hit.¹ Clinics restricted visits, and people hesitated to see physicians in places where they might contract COVID-19. STI transmission began to rise. As rates of SARS-CoV-2 infection soared in New York City in the second quarter of 2020, STI testing sharply declined.

But the pandemic also spawned a boom in at-home testing. Governments began promoting at-home COVID-19 testing as a way for people to check their status before travelling or socializing. As a result, physicians, researchers, and the public became more comfortable about the accuracy and utility of home-testing kits in general. And proponents hope that the popularity of at-home COVID-19 testing will boost the use of and demand for at-home STI tests. There are signs that that is already occurring.

On January 1, 2022, for example, the state of California enacted legislation (SB-306) requiring health insurance to cover at-home STI testing kits and syphilis screening during both the first and third trimester of pregnancy, in addition to other mitigation strategies.²

Self-testing Addresses Some Barriers

Direct-to-consumer testing can address documented barriers to STI testing, including inconvenience, privacy concerns, and the sense of stigma associated with seeking STI-specific care.³ Compared with face-to-face care, it is perceived as offering more privacy, a primary concern among teens and young adults. Furthermore, the use of direct-to-consumer test services could improve access to testing for persons who otherwise would not attend clinics because of limited access.

Direct-to-consumer test services may also be advantageous to clinicians and clinical programs. The Centers for Disease Control and Prevention and the U.S. Preventive Services Task Force recommend annual STI screening for sexually active women younger than 25 years and more frequent screening for persons on preexposure prophylaxis. Direct-to-consumer test services may reduce the burden on healthcare providers who cite insufficient time and staff as barriers to performing routine STI screening, particularly among asymptomatic persons.

Direct-to-consumer test services may reduce the burden on healthcare providers who cite insufficient time and staff as barriers to performing routine STI screening, particularly among asymptomatic persons.

Direct-to-consumer STI test services also have the potential to provide substantial support to the overall public health effort to control STIs. Identifying STIs, particularly asymptomatic cases, is a critical component of reducing transmission^, thus, any program that increases rates of testing may enhance overall control efforts. It is also conceivable that this strategy could improve the quality of partner management services by directing contacts to use at-home testing. But at-home testing for STIs presents concerns as well.

Concerns

Regulation of online tests is often lacking, and the quality of services is variable, with potential short-term and long-term personal, clinical and public health implications.⁴ A 2020 United Kingdom study of at-home STI testing providers identified many conflicts with national guidelines, including lack of health promotion information, lack of sexual history-taking, use of tests licensed for professional-use only marketed for self-testing, inappropriate infections tested for, incorrect specimen type used and lack of advice for postdiagnosis management.

The study evaluated online providers of self-testing services (i.e., those whose test results are interpreted by the patient in the home) and self-sampling services (i.e., those whose tests are sent to a lab for analysis) along five parameters, which correspond with BASHH standards for the management of STIs. Researchers found shortcomings in most:

• Test audience and pretest process. Although low-risk symptomatic patients were eligible to use online services at the time of data collection due to COVID-19 modifications, private self-sample providers who advertised to symptomatic patients did not distinguish between severity of symptoms, and testing for individuals with severe symptoms, including pelvic pain, was recommended.

• Test process. Multiple private self-sample services offered tests individually or within bundles for organisms generally regarded as commensal (i.e., that induce protective responses that prevent colonization and invasion by pathogens). Private self-sample providers sometimes exaggerated the importance of testing for these commensal organisms when compared with the literature. In addition, Gardnerella infection was repeatedly used as a proxy for bacterial vaginosis, contrary to recommendations. What’s more, specimen type often conflicted with guidelines. Several self-test providers, for example, requested cervical samples, which should be clinician-collected. For herpes, some self-sample providers requested urine samples despite BASHH guidance that states that urine tests are inappropriate for the diagnosis of herpes (and that lesion swabs should be taken for Nucleic Acid Amplification Testing, or blood for serology in certain circumstances).

• Health information and signposting. Several providers of self-sample tests provided information on window periods, transmission routes, symptoms and infection prevention. However, others neglected to include such information on the test page or inconsistently mentioned it. One private self-sample provider gave links to Wikipedia.

• Follow-up/treatment. The researchers had difficulty assessing information on test follow-up, as postdiagnosis processes were not always shared. The self-test providers that did include this information advised seeing a health professional after a positive result. The researchers did note that one self-sample provider offered an oral course of azithromycin and cefixime for gonorrhoea (easy available online) instead of the recommended first-line treatment of intramuscular ceftriaxone.

• Accreditation. Although the UK standards do not refer to accreditation for self-tests, it is recommended that they hold the CE mark. Among the self-test-providers studied, 11 had at least one of their tests CE-marked, two claimed World Health Organization approval and one claimed U.S. Food and Drug Administration accreditation.

Online testing is a welcome addition to STI diagnostics, offering a convenient and flexible option for users.⁵ However, the proliferation of providers that do not follow guidelines, in particular for-profit sites, jeopardizes these advantages and puts users at risk.

Footnotes

1. Home testing for syphilis gains support in wake of COVID.
2. New California Law Addresses STI Epidemic With At-Home Test Kits
3. Direct-to-Consumer Sexually Transmitted Infection Testing Services: A Position Statement from the American Sexually Transmitted Diseases Association
4. Assessment of online self-testing and self-sampling service providers for sexually transmitted infections against national standards in the UK in 2020
5. At-Home Specimen Self-Collection and Self-Testing for Sexually Transmitted Infection Screening Demand Accelerated by the COVID-19 Pandemic: a Review of Laboratory Implementation Issues.