Forensic application and evaluation of a commercially available pregabalin immunoassay test in serum on an Olympus AU480

Misuse of pregabalin and its forensic relevance is steadily increasing. The aim of this study was to evaluate the usability of the commercially available ARKTM Pregabalin II Assay (ARK Diagnostics) for serum analysis of forensic samples. Overall, 156 samples were tested by both the immunoassay and a validated liquid chromatographic–tandem mass spectrometric (LC-MS/MS) method. Sensitivity was 100%, and specificity was 98.7% (n = 79 positive cases confirmed by LC-MS/MS in a range of 380–37,000 ng/mL). A good correlation (R² = 0.73) could also be shown between quantitative immunoassay and LC-MS/MS results. In conclusion, the assay shows excellent reliability for screening of forensic serum samples.