Review Article| Volume 32, ISSUE 3, P429-447, September 2012

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The Utility of Immunoassays for Urine Drug Testing

      Substance abuse is a significant problem in the United States.
      Substance Abuse and Mental Health Services Administration
      Data, outcomes, and quality.
      Over 2.1 million emergency department visits in 2009 were associated with drug misuse or abuse, of which 47% involved an illicit drug and 31.8% involved alcohol. Cocaine, marijuana, alcohol, and heroin were the most commonly abused drugs. In addition, pain and addiction management physicians are managing an increasing number of patients with prescriptions for addictive and/or narcotic drugs. Consequently, 52.1% of emergency department visits involved inappropriate use of pharmaceutical drugs. Because of the extent of drug abuse in the population, urine drug testing (UDT) for drugs of abuse (DOA) is commonly performed in laboratories to assist with patient management.
      Key Points
      • Immunoassays, as opposed to chromatographic or mass spectrometry methods, are clinically desirable because they provide a rapid turnaround time, allow physicians to make timely decisions regarding patient management, and are more easily integrated into the laboratory workflow.
      • Accuracy and precision studies are required, at a minimum, to validate all US Food and Drug Administration–approved qualitative immunoassays for drugs of abuse.
      • Laboratory directors must determine an appropriate sample type, test menu, cutoffs, method of reporting (eg, quantitative vs qualitative), and testing location (eg, central laboratory vs point of care), as well as recognize and reduce analytical interferences and potential sample adulteration.
      • Although immunoassays are rapid, relatively inexpensive, and easy to automate, there are some limitations including poor sensitivity and specificity.
      • Because of the breadth and complexity of testing, clinicians are frequently unaware of the limitations of urine drug screens and how inaccurate interpretation of results can adversely affect patient management; therefore, laboratory directors play an integral role in interpreting urine drug test results and communicating results to clinicians.


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