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Test Code PMHPU Pain Management Hybrid Profile, 22 Drug Classes, High-Resolution Mass Spectrometry and Immunoassay Screen, Random, Urine


Ordering Guidance


This test does not screen for drug classes other than those listed in Reference Values.



Specimen Required


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 test.


Useful For

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

 

Clinical monitoring or management of patients

 

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

Profile Information

Test ID Reporting Name Available Separately Always Performed
LPCM List Patient's Current Medications No Yes
ADULT Adulterants Survey, U Yes Yes
LDPU Limited Drug Panel, 3, IA, U No Yes
TOPU Targeted Opioid MS Screen, U Yes, (Order TOSU) Yes
TABSU Targeted Benzodiazepine Screen, U Yes, (Order TBSU) Yes
TSIM Gabapentinoid/Stim MS Screen, U Yes, (Order TGSU) Yes
ETGSR Ethyl Glucuronide Scrn w/Reflex, U No Yes

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
ETGC Ethyl Glucuronide Confirmation, U Yes No

Method Name

ADULT: Spectrophotometry (SP)

ETGSR, LDPU: Immunoassay

TABSU, TOPU, TSIM: Liquid Chromatography Tandem Mass Spectrometry, High-Resolution Accurate Mass (LC-MS/MS HRAM)

Reporting Name

Pain Mgt Profile, 22, HRMS/IA, U

Specimen Type

Urine

Specimen Minimum Volume

20 mL

Specimen Stability Information

Specimen Type Temperature Time
Urine Refrigerated (preferred) 14 days
  Frozen  14 days

Reject Due To

  All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.

Clinical Information

The limited drug profile uses screening techniques that involves immunoassay testing and was designed to test for barbiturates, cocaine, and carboxy- tetrahydrocannabinol. All positive immunoassay screening results can be confirmed by gas chromatography mass spectrometry or liquid chromatography tandem mass spectrometry (LC-MS/MS) and quantitated if applicable.

 

Ethyl glucuronide is tested by immunoassay and confirmed by 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 for opioids include drowsiness, confusion, nausea, constipation, and, in severe cases, respiratory depression. These are dose-dependent and vary with tolerance. 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 does not 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 either 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 drugs 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 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.

 

Gabapentinoids (pregabalin, gabapentin) are widely used in neurology, psychiatry, and primary care, with increasing reports of misuse. They decrease central neuronal excitability by binding to the calcium channel of hyperexcited neurons which results in a reduction in the release of excitatory molecules including glutamate and noradrenaline. Gabapentin is not metabolized or protein bound and is primarily excreted and detectable in the urine for up to four days. Pregabalin is also largely excreted unchanged in the urine and detectable for up to 6 days.

 

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.

 

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

Reference Values

ADULTERANT SURVEY:

Cutoff concentrations

Oxidants: 200 mg/L

Nitrites: 500 mg/L

 

LIMITED DRUG PROFILE, 3 DRUG CLASSES, IMMUNOASSAY PANEL:

Negative

Screening cutoff concentrations:

Barbiturates: 200 ng/mL

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

Tetrahydrocannabinol carboxylic acid: 50 ng/mL

 

TARGETED OPIOID MASS SPECTROMETRY SCREEN:

Not detected (Positive results are reported with qualitative "Present" results)

 

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

2-Ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP): 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 MASS SPECTROMETRY SCREEN:

Not detected (Positive results are reported with qualitative "Present" results)

 

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-hydroxymidazolam: 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-hydroxytriazolam: 10 ng/mL

Zolpidem: 10 ng/mL

Zolpidem phenyl-4-carboxylic acid: 10 ng/mL

 

TARGETED GABAPENTINOID AND STIMULANT MASS SPECTROMETRY SCREEN:

Not detected (Positive results are reported with qualitative "Present" results)

 

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

Gabapentin: 500 ng/mL

Pregabalin: 500 ng/mL

 

ETHYL GLUCURONIDE SCREEN:

Negative

Screening cutoff concentrations:

Ethyl glucuronide: 500 ng/mL

Day(s) Performed

Monday through Saturday

Report Available

3 to 4 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

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.

CPT Code Information

G0482

80307

80364 (if appropriate for select payers)

80347 (if appropriate for select payers)

80326 (if appropriate for select payers)

80321 (if appropriate for select payers)

Clinical Toxicology CPT Code Client Guidance