Interpretation and Utility of Drug of Abuse Screening Immunoassays: Insights From Laboratory Drug Testing Proficiency Surveys.

CONTEXT.—:Urine drug testing is frequently ordered by health care providers. Immunoassays are widely used for drug testing, yet have potential limitations, including variable cross-reactivity. The last decade has seen worsening of a prescription drug abuse epidemic. OBJECTIVE.—:To use data from a College of American Pathologists proficiency testing survey, Urine Drug Testing, Screening, to determine and summarize the characteristics, performance, and limitations of immunoassays. DESIGN.—:Seven years of proficiency surveys were reviewed (2011-2017). RESULTS.—:Rapid growth was seen in participant volumes for specific immunoassays for synthetic opioids (eg, buprenorphine, fentanyl, oxycodone) and 3,4-methylenedioxymethamphetamine ("ecstasy"). Participant volumes remained high for immunoassays targeting less commonly abused drugs such as barbiturates and phencyclidine. For opiate immunoassays, the number of laboratories using a 2000 ng/mL positive cutoff remained stable, and an increasing number adopted a 100 ng/mL cutoff. Opiate and amphetamine immunoassays showed high variability in cross-reactivity for drugs other than the assay calibrator. Assays targeting a single drug or metabolite generally performed well on drug challenges. CONCLUSIONS.—:Survey results indicate strong clinical interest in urine drug testing and some adoption of new assays. However, urine drug testing availability does not parallel prevailing patterns of drug prescribing and abuse patterns. In particular, specific immunoassays for synthetic opioids and a lower positive cutoff for opiate immunoassays may be underused, whereas immunoassays for barbiturates, methadone, propoxyphene, and phencyclidine may be overused. Laboratories are encouraged to review their test menu, cutoffs, and assay performance and adjust their test offerings based on clinical needs and technical capabilities.