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Clin Lab Med. 2020 Mar;40(1):25-36. doi: 10.1016/j.cll.2019.11.006.

Challenges with At-home and Mail-in Direct-to-Consumer Testing: Preanalytical Error, Reporting Results, and Result Interpretation.

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Department of Pathology and Laboratory Medicine, University of Wisconsin School of Medicine and Public Health, 600 Highland Ave Madison, WI 53792, USA.
Department of Laboratory Medicine and Pathology, Mayo Clinic, 200 First St SW, Hilton 3-70, Rochester, MN 55905, USA. Electronic address:


Companies that offer direct-to-consumer (DTC) testing on specimens such as saliva, blood, or urine, allow consumers to order laboratory tests without the involvement of a health care provider. This approach allows individuals to have direct access to their own laboratory results, interpret them, and make decisions regarding their health care. However, as with conventional clinical laboratory testing, there are factors that will impact the accuracy of DTC test results and limitations that consumers need to be aware of. This article focuses on challenges with DTC testing specifically related to preanalytical errors, result reporting, and result interpretation.


DTC testing; Postanalytics; Preanalytics; Total testing process


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