Test Id : CSMEU

Testing begins with an adulterant survey. If the sample is found to be adulterated, testing will end, and the remaining tests will be canceled.

If the specimen is normal or only diluted, remaining testing will continue.

If immunoassay screen is positive, confirmation testing can be ordered separately. Confirmation with quantification of positives for barbiturates, cocaine and metabolites, tetrahydrocannabinol metabolite, and ethyl glucuronide/ethyl sulfate will be performed at an additional charge.

This test does not screen for drug classes other than those listed above.

Supplies: Urine Container, 60 mL (T313)

Collection Container/Tube: Plastic urine container

Submission Container/Tube: Plastic, 60 mL urine container

Specimen Volume: 30 mL

Collection Instructions:

1. Collect a random urine specimen.

2. Submit 30 mL in 1 plastic bottle.

3. No preservative.

Additional Information:

1. No specimen substitutions.

2. Submitting less than 30 mL may compromise the ability to perform all necessary testing.

3. STAT requests are not accepted for this procedure.

If not ordering electronically, complete, print, and send a Therapeutics Test Request (T831) with the specimen.

20 mL

Detecting drug use involving stimulants, barbiturate, benzodiazepines, cocaine, opioids, tetrahydrocannabinol, and alcohol

This test is not intended for use in employment-related testing.

Testing begins with an adulterant survey. If the sample is found to be adulterated, testing will end, and the remaining tests will be canceled.

If the specimen is normal or only diluted, remaining testing will continue.

If immunoassay screen is positive, confirmation testing can be ordered separately. Confirmation with quantification of positives for barbiturates, cocaine and metabolites, tetrahydrocannabinol metabolite, and ethyl glucuronide/ethyl sulfate will be performed at an additional charge.

This test uses screening techniques that involves immunologic testing and high-resolution accurate mass spectrometry screening for drugs by class. All positive immunoassay screening results are confirmed by gas chromatography-mass spectrometry (GC-MS) or liquid chromatography-tandem mass spectrometry (LC-MS/MS), and quantitated, before a positive result is reported.

The following drugs/drug classes are tested by immunoassay and confirmed by GC-MS:

-Barbiturates

-Cocaine

-Tetrahydrocannabinol

Ethyl glucuronide is also screened using an immunoassay and confirmation of ethyl glucuronide/ethyl sulfate is performed using LC-MS/MS.

The targeted opioid, benzodiazepine, and stimulant screen portions are performed using liquid chromatography-tandem mass spectrometry, high-resolution accurate mass (HRAM) and are completed for all opioids, benzodiazepines, and stimulants. Opioids are a large class of medications commonly used to relieve acute and chronic pain or help manage opioid abuse and dependence. Medications that fall into this class include buprenorphine, codeine, fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, tapentadol, tramadol, and others. Opioids work by binding to the opioid receptors that are found in the brain, spinal cord, gastrointestinal tract, and other organs. Common side effects include drowsiness, confusion, nausea, constipation, and, in severe cases, respiratory depression depending on the dose. These medications can also produce physical and psychological dependence and have a high risk for abuse and diversion, which is one of the main reasons many professional practice guidelines recommend compliance testing in patients prescribed these medications.

Opioids are readily absorbed from the gastrointestinal tract, nasal mucosa, lungs, and after subcutaneous or intermuscular injection. Opioids are primarily excreted from the kidney in both free and conjugated forms. This assay doesn't hydrolyze the urine sample and looks for both parent drugs and metabolites (including glucuronide forms). The detection window for most opioids in urine is approximately 1 to 3 days with longer detection times for some compounds (ie, methadone).

Benzodiazepines represent a large family of medications used to treat a wide range of disorders from anxiety to seizures and are also used in pain management. With a high risk for abuse and diversion, professional practice guidelines recommend compliance monitoring for these medications using urine drug tests. However, traditional benzodiazepine immunoassays suffer from a lack of cross-reactivity with all the benzodiazepines, so many compliant patients taking clonazepam (Klonopin) or lorazepam (Ativan) may screen negative by immunoassay but are positive when confirmatory testing is done. The new targeted benzodiazepine screening test provides a more sensitive and specific test to check for compliance to all the commonly prescribed benzodiazepines and looks for both parent and metabolites in the urine.

Stimulants are sympathomimetic amines that stimulate the central nervous system activity and, in part, suppress the appetite. Amphetamine and methamphetamine are also prescription drugs used in the treatment of narcolepsy and attention-deficit disorder/attention-deficit hyperactivity disorder (ADHD). Methylphenidate is another stimulant used to treat ADHD. Phentermine is indicated for the management of obesity. All of the other amphetamines (eg, methylenedioxymethamphetamine: MDMA) are Drug Enforcement Administration scheduled Class I compounds. Due to their stimulant effects, the drugs are commonly sold illicitly and abused. Physiological symptoms associated with very high amounts of ingested amphetamine or methamphetamine include elevated blood pressure, dilated pupils, hyperthermia, convulsions, and acute amphetamine psychosis.

Ethyl glucuronide is a direct metabolite of ethanol that is formed by enzymatic conjugation of ethanol with glucuronic acid. Alcohol in urine is normally detected for only a few hours, whereas ethyl glucuronide can be detected in the urine for 1 to 5 days. This procedure uses immunoassay reagents that are designed to produce a negative result when no drugs are present in a natural (eg, unadulterated) specimen of urine; the assay is designed to have a high true-negative rate. Like all immunoassays, it can have a false-positive rate due to cross-reactivity with natural chemicals and drugs other than those they were designed to detect. The immunoassay also has a false-negative rate to the antibody's ability to cross-react with different drugs in the class being screened for.

This test is intended to be used in a setting where the test results can be used to make a definitive diagnosis

ADULTERANT SURVEY:

Cutoff concentrations

Oxidants: 200 mg/L

Nitrites: 500 mg/L

DRUG IMMUNOASSAY PANEL:

Negative

Screening cutoff concentrations:

Barbiturates: 200 ng/mL

Cocaine (benzoylecgonine-cocaine metabolite): 150 ng/mL

Tetrahydrocannabinol carboxylic acid: 50 ng/mL

This report is intended for use in clinical monitoring or management of patients. It is not intended for use in employment-related testing.

TARGETED OPIOID SCREEN:

Not Detected

Cutoff concentrations:

Codeine: 25 ng/mL

Codeine-6-beta-glucuronide: 100 ng/mL

Morphine: 25 ng/mL

Morphine-6-beta-glucuronide: 100 ng/mL

6-monoacetylmorphine: 25 ng/mL

Hydrocodone: 25 ng/mL

Norhydrocodone: 25 ng/mL

Dihydrocodeine: 25 ng/mL

Hydromorphone: 25 ng/mL

Hydromorphone-3-beta-glucuronide: 100 ng/mL

Oxycodone: 25 ng/mL

Noroxycodone: 25 ng/mL

Oxymorphone: 25 ng/mL

Oxymorphone-3-beta-glucuronide: 100 ng/mL

Noroxymorphone: 25 ng/mL

Fentanyl: 2 ng/mL

Norfentanyl: 2 ng/mL

Meperidine: 25 ng/mL

Normeperidine: 25 ng/mL

Naloxone: 25 ng/mL

Naloxone-3-beta-glucuronide: 100 ng/mL

Methadone: 25 ng/mL

EDDP: 25 ng/mL

Propoxyphene: 25 ng/mL

Norpropoxyphene: 25 ng/mL

Tramadol: 25 ng/mL

O-desmethyltramadol: 25 ng/mL

Tapentadol: 25 ng/mL

N-desmethyltapentadol: 50 ng/mL

Tapentadol-beta-glucuronide: 100 ng/mL

Buprenorphine: 5 ng/mL

Norbuprenorphine: 5 ng/mL

Norbuprenorphine glucuronide: 20 ng/mL

TARGETED BENZODIAZEPINE SCREEN:

Not Detected

Cutoff concentrations:

Alprazolam: 10 ng/mL

Alpha-Hydroxyalprazolam: 10 ng/mL

Alpha-Hydroxyalprazolam Glucuronide: 50 ng/mL

Chlordiazepoxide: 10 ng/mL

Clobazam: 10 ng/mL

N-Desmethylclobazam: 200 ng/mL

Clonazepam: 10 ng/mL

7-aminoclonazepam: 10 ng/mL

Diazepam: 10 ng/mL

Nordiazepam: 10 ng/mL

Flunitrazepam: 10 ng/mL

7-aminoflunitrazepam: 10 ng/mL

Flurazepam: 10 ng/mL

2-Hydroxy Ethyl Flurazepam: 10 ng/mL

Lorazepam: 10 ng/mL

Lorazepam Glucuronide: 50 ng/mL

Midazolam: 10 ng/mL

Alpha-Hydroxy Midazolam: 10 ng/mL

Oxazepam: 10 ng/mL

Oxazepam Glucuronide: 50 ng/mL

Prazepam: 10 ng/mL

Temazepam: 10 ng/mL

Temazepam Glucuronide: 50 ng/mL

Triazolam: 10 ng/mL

Alpha-Hydroxy Triazolam: 10 ng/mL

Zolpidem: 10 ng/mL

Zolpidem Phenyl-4-Carboxylic acid: 10 ng/mL

TARGETED STIMULANT SCREEN:

Not Detected

Cutoff concentrations:

Methamphetamine: 100 ng/mL

Amphetamine: 100 ng/mL

3,4-methylenedioxymethamphetamine (MDMA): 100 ng/mL

3,4-methylenedioxy-N-ethylamphetamine (MDEA): 100 ng/mL

3,4-methylenedioxyamphetamine (MDA): 100 ng/mL

Ephedrine: 100 ng/mL

Pseudoephedrine: 100 ng/mL

Phentermine: 100 ng/mL

Phencyclidine (PCP): 20 ng/mL

Methylphenidate: 20 ng/mL

Ritalinic acid: 100 ng/mL

ETHYL GLUCURONIDE SCREEN:

Negative

Screening cutoff concentrations:

Ethyl Glucuronide: 500 ng/mL

A positive result derived by this testing indicates that the patient has used one of the drugs detected by these techniques in the recent past. See individual tests (eg, COKEU / Cocaine and Metabolite Confirmation, Random, Urine) for more information.

For information about drug testing, including estimated detection times and Result Interpretations, see Controlled Substance Monitoring on MayoClinicLabs.com.

In regards to ethyl glucuronide testing, care should be taken when interpreting results since there are many factors (eg, fluid intake and other biologic factors) that may influence a urine test result. It is possible that substances other than those investigated in the specificity study may interfere with the test and cause false-positive or false-negative results.

1. Physicians' Desk Reference; 60th ed. Medical Economics Company, 2006

2. Bruntman LL, ed. Goodman and Gilman's: The Pharmacological Basis of Therapeutics. 11th ed. McGraw-Hill Book Company; 2006

3. Langman LJ, Bechtel L, Meier BM, Holstege CP: Clinical toxicology In: Rifai N, Horwath AR, Wittwer CT, eds: Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. 6th ed. Elsevier; 2018:832-887

4. Gutstein HB, Akil H: Opioid analgesics. In: Brunton LL, Lazo JS, Parker KL, eds: Goodman and Gilman's: The Pharmacological Basis of Therapeutics. 11th ed. McGraw-Hill Companies; 2006

5. Chronic Pain in America: Roadblocks to Relief, survey conducted for the American Pain Society, The American Academy of the Pain Medicine and Janssen Pharmaceutical, 1999

6. Magnani B, Kwong T: Urine drug testing for pain management. Clin Lab Med. 2012;32(32):379-390

7. Jannetto PJ, Bratanow NC, Clark WA, et al: Executive summary: American Association of Clinical Chemistry Laboratory Medicine Practice Guideline-using clinical laboratory tests to monitor drug therapy in pain management patients. J Appl Lab Med. 2018;2(4):489-526

8. McMillin GA, Marin SJ, Johnson-Davis KL, Lawlor BG, Strathmann FG: A hybrid approach to urine drug testing using high-resolution mass spectrometry and select immunoassays. Am J Clin Pathol. 2015;143(2):234-240

9. Cone EJ, Caplan YH, Black DL, Robert T, Moser F: Urine drug testing of chronic pain patients: licit and illicit drug patterns. J Anal Toxicol. 2008;32(8):530-543

Adulterant:

All results are measured using spectrophotometry at wavelengths specified by the reagent manufacturer. The use of a refractometer may also be used in the specific gravity measurement.(Package insert: Creatinine plus ver 2, Specimen Validity Test Nitrite, Specimen Validity Test Oxidant, Specimen Validity Test pH, Specimen Validity Test Specific Gravity, Roche Diagnostics; 12/2016)

Drug Panel:

The barbiturate, cocaine metabolite, and tetrahydrocannabinol metabolite assays are based on the kinetic interaction of microparticles in a solution as measured by changes in light transmission. In the absence of sample drug, soluble drug conjugates bind to antibody-bound microparticles, causing the formation of particle aggregates. As the aggregation reaction proceeds in the absence of sample drug, the absorbance increases. When a urine sample contains the drug in question, this drug competes with the drug derivative conjugate for microparticle-bound antibody. Antibody bound to sample drug is no longer available to promote particle aggregation, and subsequent particle lattice formation is inhibited. The presence of sample drug diminishes the increasing absorbance in proportion to the concentration of drug in the sample. Sample drug content is determined relative to the value obtained for a known cutoff concentration of drug.(Package inserts: Barbiturates. Roche Diagnostics; 11/2017; Cannabinoids. Roche Diagnostics; 11/2017; Cocaine. Roche Diagnostics; 11/2017)

Targeted Screening Panels for opioids, benzodiazepines, and stimulants:

The urine sample is diluted with internal standard and clinical laboratory reagent water and then analyzed by liquid chromatography- tandem mass spectrometry using a high resolution-accurate mass orbi-trap detector.(Unpublished Mayo method)

Ethyl Glucuronide Screen:

This assay is a homogeneous enzyme-linked immunosorbent assay (EIA) technique. The assay will be performed semiquantitatively. The assay is based on competition between free drug in the urine sample, and a drug labeled with the enzyme glucose-6-phosphate dehydrogenase for a fixed amount of specific antibody binding sites. Active enzyme converts nicotinamide adenine dinucleotide (NAD+) to NADH, which results in an absorbance change that can be measured spectrophotometrically at 340 nm.(Package insert: DRI Ethyl Glucuronide Assay. Microgenics Corporation; 09/2015)

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This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.

80307

80347

80364

80326

G0482 (if appropriate)