A Template for the Validation of DART-MS for Qualitative Seized Drugs Analysis

Direct analysis in real time mass spectrometry (DART-MS) is an increasingly employed tool for a wide range of forensic applications including seized drug analysis. A significant body of research surrounds DART-MS for the analysis of seized drugs and how it can be used to address many of the challenges caused by the increased presence of emerging drugs and novel psychoactive substances. A lack of available resources to help address validation, operation, training, and data interpretation needs is just one of the hurdles that laboratories face when adopting new technologies, such as DART-MS. To provide additional resources to assist in validation development, this work provides a template that can be adopted or adapted for DART-MS or other ambient ionization mass spectrometry techniques for qualitative seized drug analysis. The template, which was created as a result of recent implementation efforts, provides a description of validation studies with a focus on understanding the potential challenges and limitations caused by the prevalence of novel psychoactive substances and other emerging drugs. The studies address accuracy and precision, reproducibility, specificity, sensitivity, environmental factors, use in casework, and robustness. In addition to providing a template for validation, the results obtained from completing these studies on two high-resolution DART-MS systems are also presented. This work, and the corresponding supplemental information, was created to add to the available resources that laboratories can leverage to assist in overcoming the adoption hurdles of ambient ionization mass spectrometry methods such as DART-MS.