This document addresses the clinical validity and utility of deoxyribonucleic acid (DNA) verification tests intended to validate the identity of laboratory specimens following collection. In particular, the know error^® DNA Specimen Provenance Assay (DSPA; Strand Diagnostics, LLC; Indianapolis, IN), is designed to confirm the identity of a biopsy specimen, the ToxProtect^™  DNA-verified Urine Drug Test (UDT) (Genotox Laboratories, Austin, TX) is used to verify the identity of urine specimens for drug screening, and other tests that analyze genetic material to identify specimens (Note: confirmation of specimen identification is a laboratory quality control issue.

Position Statement

Not Medically Necessary:

Genetic testing to confirm the identity of a laboratory specimen (for example, know error DNA Specimen Provenance Assay [DSPA] or ToxProtect) is considered not medically necessary.