Direct-to-Consumer Disease Screening with Finger-Stick Testing: Online Patient Safety Risks

Abstract

The direct-to-consumer (DTC)6 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 self-diagnosis 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 evidence-based applications, patient safety protections, and responsible advertising that accurately reflects risks and utility. Offering DTC finger-stick medical testing in conjunction with information suggesting potentially abnormal results may in fact constitute unauthorized medical practice. According to the Federation of State Medical Boards, medical practice includes “offering or undertaking to prevent or diagnose … by any means … or devices any disease, illness, pain, … or abnormal physical condition of any person … .” (7). Many DTC medical-testing companies seem to fit squarely within this definition. Indeed, a simple Google search for “home testing kits” yields a panoply of DTC finger-stick tests: lipids (total, LDL, and HDL cholesterol; triglycerides), high-sensitivity C-reactive protein (hs-CRP), aspartate …