Ethanol Biomarker Testing and Challenges Lessons Learned From a College of American Pathologists Proficiency Testing Survey

Context.-Clinical and forensic testing for ethanol biomarkers, including ethyl glucuronide (EtG) and ethyl sulfate (EtS), is used to discern alcohol use from abstinence. These markers can be key in major decisions, including transplant eligibility or retaining licensure after alcohol misuse. Accuracy, precision, and recognition of the implications of reporting cutoffs are all essential for correct interpretation. Objective.-To evaluate trends in testing for EtG and EtS, including how laboratories perform testing and how comparable participant results are. Design.-The study examined the College of American Pathologists ethanol biomarker proficiency testing survey from 2013 to 2019. Trends in methodology, reporting cutoffs, and participant performance were evaluated for qualitative and quantitative EtG testing and for quantitative EtS testing. Results.-There was little consensus in reporting cutoffs, which ranged from 10 to 1000 ng/mL for EtG and 10 to 1500 ng/mL for EtS. Although median EtG and EtS compared well with target concentrations, individual participants' results varied widely. For quantitative enzyme immunoassay, accuracy and precision were best in EtG challenges less than 1500 ng/mL. For EtG or EtS by mass spectrometry, overall accuracy was good over a wide concentration range, but variability between participants was high. Approximately 10% (409 of 4059) of results were unacceptable, which for mass spectrometry corresponded to more than 35% above or below the group mean. Conclusions.-Although many participants performed well, there was insufficient consensus in reporting cutoffs, and a consistent fraction of laboratories failed to achieve survey standards. Guidelines for assay performance and reporting could greatly benefit laboratories and end users. (Arch Pathol Lab Med. 2021;145:1492-1498 ; doi: 10.5858/arpa.2020-0699-CP)