From the Department of Public Health Sciences, College of Medicine, The Pennsylvania State University, Hershey, PA.
Heersink School of Medicine, University of Alabama at Birmingham, Birmingham, AL.
Sex Transm Dis. 2023 Jun 1;50(6):323-328. doi: 10.1097/OLQ.0000000000001783. Epub 2023 Feb 20.
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.
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.
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.
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.
性传播感染（STI）的患病率处于历史最高水平。直接面向消费者的 STI 检测服务可能有助于减轻这种不必要的健康负担。这些产品在网上销售，很少需要与医疗保健专业人员（HCP）互动。供应商提供 STI 自我采集试剂盒或 HCP 标本采集的处方。目的是了解提供的直接面向消费者的 STI 检测服务的范围，并为消费者和行业提供建议。
七名志愿者于 2021 年 2 月 1 日至 3 月 31 日在 Google 上搜索“STD 测试”，并分享了他们的前 3 个结果。研究团队从每个网站面向消费者的信息中提取数据。进行了描述性统计和主题定性分析。
确定了 20 家供应商。大多数供应商（95%）使用临床实验室改进修正案（CLIA）认证或美国病理学家学院（CAP）认可的实验室。分析区分了使用独立实验室的 STI 自我采集试剂盒（n=9）和使用商业实验室的 HCP 标本采集（n=10）（一种提供两者）。每份测试的 STI 自我采集试剂盒更便宜，平均捆绑（例如，衣原体/淋病的 79.00 美元与 106.50 美元），与 HCP 标本采集选项相比，更符合临床建议。网站经常包含不准确或误导性信息（n=13），经常在推荐之外进行测试推广。
直接面向消费者的 STI 检测服务是一个缺乏监管的新兴市场的一部分。消费者应选择在 CAP 认可和 CLIA 认证实验室提供 HCP 标本采集处方的供应商。供应商应在购买测试前提供一个筛查工具，以评估个体患者的风险。
