Direct-to-consumer disease screening with finger-stick testing: online patient safety risks.

The direct-to-consumer (DTC) medical industry (i.e., medical testing and treatment outside of physician oversight) is growing rapidly as the Internet becomes more accessible globally. As several studies have highlighted, this industry offers unproven medical testing, provides testing for unapproved indications, and uses suspect advertising claims (1–5 ). Furthermore, given the prevalence of illicit pharmaceutical marketing (6 ), consumers are confronted with systemic online selfdiagnosis and self-treatment risks that have emerged as a global patient safety and public health issue. One particularly troubling practice DTC companies commonly use is finger-stick (capillary blood) testing for disease screening and diagnosis. Although useful in some clinical point-of-care applications, finger-stick testing carries substantial risks when offered to the consumer for screening, diagnosis, or disease monitoring without professional oversight. Although other nonvenipuncture alternative-site testing carries many of the same risks, we focus specifically on the dangers of finger-stick testing because of its widespread use by DTC vendors. Because of the present situation and the unique patient safety risks we outline below (e.g., low diagnostic sensitivity, strip factors, logistics of testing), creating a regulatory framework for finger-stick testing could ensure legitimate evidencebased applications, patient safety protections, and responsible advertising that accurately reflects risks and utility. Unauthorized Practice of Medicine