Impaction-Based Exhaled Breath Sampling for Substance Monitoring: A Prospective Pilot Study (DrugXhale).

Abstract

For decades, intake monitoring of drugs using urine as the matrix of choice is the gold standard in drug treatment centers. A properly conducted urine drug test can identify recent use of prescribed, non-prescribed and illicit drugs. However, issues like adulteration, substitution and privacy issues have driven the search for alternative matrices. This prospective pilot study evaluates the use of an impaction-based breath sampling device, Breath Explor®, as an alternative to traditional urine-based drug monitoring. Breath samples were analyzed using a validated 32-component liquid chromatography-tandem mass spectrometry (LC-MSMS) method. Recovery data represent the efficiency of extracting the analytes from the breath devices. Both automated and manual processing of the Breath Explor® devices showed mean recovery rates ranging from 39.5% to 55.4% for the 32 analytes. Despite the small number of subjects, breath analysis proved to be a convenient and easy-to-use methodology. An overall kappa-values of 0.5 indicated a moderate level of agreement with urine analysis, underscoring its potential as a complementary diagnostic tool. All participants tested positive in their breath sample for methadone (70% methadone and 100% EDDP), while a significant portion (90%) tested positive for 6-monoacetylmorphine (6-MAM). This innovative approach offers several advantages, including non-invasiveness, reduced risk of adulteration, and the ability to perfom repeated automated sampling and confirmation testing. These findings suggest that breath-based substance monitoring could complement or even replace traditional urine-based methods in clinical practice.