A Review of the Scope of Direct-to-Consumer Sexually Transmitted Infection Testing Services Offered on the Internet.

BACKGROUND: The prevalence of sexually transmitted infections (STIs) is at an all-time high. Direct-to-consumer STI testing services may help alleviate this undue health burden. These products are sold online and rarely require interaction with a health care professional (HCP). Vendors offer STI self-collection kits or prescriptions for HCP specimen collection. The objective was to understand the scope of direct-to-consumer STI testing services offered and provide recommendations for consumers and industry. METHODS: Seven volunteers searched for "STD tests" on Google from February 1 through March 31, 2021 and shared their top 3 results. The study team extracted data from consumer-facing information on each website. Descriptive statistics and thematic qualitative analyses were performed. RESULTS: Twenty vendors were identified. Most vendors (95%) used Clinical Laboratory Improvement Amendments (CLIA)-certified or College of American Pathologists (CAP) accredited laboratories. Analyses distinguished between STI self-collection kits (n = 9) using independent laboratories and HCP specimen collection (n = 10), which used commercial laboratories (n = 1 offered both). The STI self-collection kits were cheaper per test and bundle on average (eg, $79.00 vs. $106.50 for chlamydia/gonorrhea), and more closely aligned with clinical recommendations compared with the HCP specimen collection options. Websites often contained inaccurate or misleading information (n = 13), often promoting testing outside of the recommendations. CONCLUSIONS: Direct-to-consumer STI testing services are part of an emerging market lacking regulation. Consumers should select vendors offering prescriptions for HCP specimen collection at CAP accredited and CLIA-certified laboratories. Vendors should provide a screening tool to assess individual patient risk prior to test purchase.

Direct-to-Consumer Sexually Transmitted Infection Testing Services: A Position Statement from the American Sexually Transmitted Diseases Association.

ABSTRACT: Direct-to-consumer test services have gained popularity for sexually transmitted infections in recent years, with substantially increased use as a result of the SARS-CoV-2 (CoVID-19) global pandemic. This method of access has been variously known as "self-testing," "home testing," and "direct access testing." Although these online services may be offered through different mechanisms, here we focus on those that are consumer-driven and require self-collected samples, and sample shipment to a centralized laboratory without involvement of health care providers and/or local health departments. We provide the American Sexually Transmitted Diseases Association's position on utilization of these services and recommendations for both consumers and health care providers.

Impact of the COVID-19 Pandemic on Chlamydia and Gonorrhea Screening in the U.S.

INTRODUCTION: This study evaluates the impact of the COVID-19 pandemic on testing for common sexually transmitted infections. Specifically, changes are measured in chlamydia and gonorrhea testing and case detection among patients aged 14-49 years during the COVID-19 pandemic. METHODS: U.S. chlamydia and gonorrhea testing and positivity were analyzed on the basis of >18.6 million tests (13.6 million tests for female patients and 4.7 million tests for male patients) performed by a national reference clinical laboratory from January 2019 through June 2020. RESULTS: Chlamydia and gonorrhea testing reached a nadir in early April 2020, with decreases (relative to the baseline level) of 59% for female patients and 63% for male patients. Declines in testing were strongly associated with increases in weekly positivity rates for chlamydia (R2=0.96) and gonorrhea (R2=0.85). From March 2020 through June 2020, an expected 27,659 (26.4%) chlamydia and 5,577 (16.5%) gonorrhea cases were potentially missed. CONCLUSIONS: The COVID-19 pandemic impacted routine sexually transmitted infection services, suggesting an increase in syndromic sexually transmitted infection testing and missed asymptomatic cases. Follow-up analyses will be needed to assess the long-term implications of missed screening opportunities. These findings should serve as a warning for the potential sexual and reproductive health implications that can be expected from the overall decline in testing and potential missed cases.