Detection of drugs of abuse in urine using the Bruker Toxtyper™: Experiences in a routine clinical laboratory setting

Urine screening can be used to detect misuse of illicit drugs and validate opioid replacement therapy compliance. It is common that immunochemical assays are combined with GC-MS for these applications. Bruker has recently released an ion trap mass spectrometer, called Toxtyper™, with the potential to replace current screening algorithms to detect drug misuse. Here, we compare our current strategy of urine screening for misuse of cannabis, amphetamines, cocaine, opiates, benzodiazepine, methadone, sufentanil, and pregabalin to the Toxtyper protocols provided by the manufacturer. The analytical performance of the instrument was determined on a selected drug panel and with 188 urine samples being compared to establish concordance between our currently established approach and the Toxtyper. The lower limits of detection and identification for acetylcodeine, amphetamine, benzoylecgonine, methadone, and nordiazepam were below the common cut-offs for immunological screening assays and comparable to GC-MS. Imprecision and accuracy, both within- and between-series, were consistently <25%. Toxtyper screening for pregabalin and sufentail was less sensitive than a targeted LC-MS/MS assay. Concordance met the predefined criterion of >90% for all drugs, except for pregabalin. Cannabis misuse could not be detected due to the limited sensitivity of the Toxtyper assay protocols used and the inherent imprecision of the assay. Our study has revealed that a considerable portion of our current time-consuming protocol for screening drugs of abuse in urine, based on the combination of multiple analytical methods, could be consolidated by the Toxtyper for a majority of the most-relevant substances in our patient population.