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TEST UPDATE Pathology & Laboratory Medicine TEST CHANGE Notification Date Effective Date COCAINE URINE DRUG SCREEN REAGENT CHANGE 10/10/2013 10/14/2013 MEDICAL DIRECTOR CHEMISTRY Greg Sharp M.D. Phone: 847-5115 Assay information: Due to a reagent recall, the Chemistry laboratory changed to a new vendor for urine cocaine screens. On October 14, 2013, we will begin using a ThermoFisher DRI Microgenics cocaine metabolite assay reagent to perform all urine cocaine screens. The assay will be performed on the Ortho Clinical Diagnostics Vitros 5600 platform. The Microgenics assay uses a 300 ng/ml cut-off and has been tested to ensure comparable performance to the discontinued Ortho Clinical Diagnostics assay. If you have questions regarding this testing change, please contact Dr. Greg Sharp in the Chemistry Laboratory at 847-5115 or via email at [email protected]. Clinical Application: CONTACT INFORMATION NEWSLETTER EDITOR Lynn Bryan, lab Manager Monica Sullivan, Lab Manager Colleen Williams, Lab Communication Strategist PATHOLOGY & LABORATORY MEDICINE 111 Colchester Avnue-233MP1 Burlington, VT, 05401 PHONE (800) 847-5121 | (800) 991-2799 FAX (802) 847-5905 Cocaine (benzoylmethylegonine), is derived from the plant Erythroxylon coca, which is widely grown in South America. Cocaine is a very common illicit drug and is popularly abused in the US. Cocaine abuse can produce euphoria, arousal, garrulousness, alertness, anxiety, insomnia, hyperactivity, paranoia, severe psychosis, and even suicide. Cocaine is rapidly metabolized, with less than 5% excreted unchanged in the urine. The two major metabolites, which result from enzymatic and nonenzymatic hydrolysis, are benzoylecgonine and ecgonine methyl ester. The metabolites may be detectable in urine for up to 3 weeks after long term, heavy use of cocaine. Method: The DRI Cocaine Metabolite Assay is a homogeneous enzyme immunoassay using ready-to-use liquid reagents. The assay uses a specific antibody, which can detect benzoylecgonine in urine. The assay is based on the comparison of an enzyme glucose-6-phosphate dehydrogenase (G6PDH) labeled drug and the drug from the urine sample for a fixed amount of specific antibody binding sites. In the presence of free drug from the sample, the free drug occupies the antibody binding sites, allowing the drug-labeled G6PDH to interact with the substrate, resulting in enzyme activity. In the absence of drug in the sample, the specific antibody binds to the drug labeled with G6PDH and the enzyme activity is inhibited. This phenomenon creates a direct relationship between the drug concentration in the urine and the enzyme activity. The enzyme G6PDH activity is determined spectrophotometrically at 340 nm by measuring its ability to convert nicotinamide adenine dinucleiotide (NAD) to NADH. LABORATORY CUSTOMER SERVICE: 847-5121 OR 1 (800) 991.2799 WEB SITE: WWW.FLETCHERALLEN.ORG/LABS 2 TEST UPDATE—October, 2013 Limitations: A positive result from this assay indicates only the presence of cocaine metabolite and does not necessari- ly correlate with the extent of physiological and psychological effects. A positive result by this assay should be confirmed by another nonimmunological method such as GC or GC/MS. The test is designed for human use only. It is possible that other substances and/or factors (technical or procedural) other than those investigated in the specificity study may interfere with the test and cause false results. Ordering and Sample Information Test Name Cocaine Screen, Urine Test Code COCA FAHC Translation Code FAH5574 PRISM Code LAB278 Sample Requirements Collect 50 mL freshly voided urine specimens should be collected in a clean previously unused glass or plastic container, minimum volume 10 mL. Specimens should be refrigerated if testing is not performed within 4 hours of collection. Specimens are stable for 48 hours if refrigerated. Specimens should be frozen if longer storage is required. Expected Value Negative Screen Days Performed Daily Analytical time Same day Price No change, please contact Laboratory Customer Service (847-5121 or 1-800-9912799) for pricing information. CPT Code 80101 Test Note The Fletcher Allen Health Care laboratory stores positive urine specimens for one week frozen in case confirmatory testing is requested by the ordering clinician. Effective Date Monday October 14, 2013 LABORATORY CUSTOMER SERVICE: 847-5121 OR 1 (800) 991.2799 WEB SITE: WWW.FLETCHERALLEN.ORG/LABS