JCI - Evaluation of direct-to-consumer low-volume lab tests in healthy adults

JCI - open access



.....Direct-to-consumer service models now provide means for individuals to obtain laboratory testing outside traditional health care settings (4, 5). One company implementing this new model is Theranos, which offers a blood testing service that uses capillary tube collection and promises several advantages over traditional venipuncture: lower collection volumes (typically ≤150 μl versus ≥1.5 ml), convenience, and reduced cost — on average about 5-fold less than the 2 largest testing laboratories in the USA (Quest and LabCorp) (8). However, availability of these services varies by state, where access to offerings may be more or less restrictive according to state-level health care regulations. Furthermore, Theranos is a private company, and the technical details of their test procedures and processes are not available to the public.
Despite its commercial availability and technological promise, the Theranos collection system has not yet been evaluated through independent, rigorous, and publicly disclosed peer-review (9). To encourage transparency and rigorous scientific review of clinical laboratory testing procedures, we conducted a cohort study of 60 individuals from July 27, 2015, to July 31, 2015, to compare the accuracy and equivalency of clinical laboratory test blood collected via finger prick and tested at Theranos against traditional venipuncture, followed by laboratory testing offered through Quest Diagnostics and LabCorp.....