Test Catalog

Test Id : OPATX

Opiates Confirmation, Chain of Custody, Random, Urine

Useful For
Suggests clinical disorders or settings where the test may be helpful

Detection and quantification of codeine, hydrocodone, oxycodone, morphine, hydromorphone, oxymorphone, noroxycodone, noroxymorphone, norhydrocodone, dihydrocodeine, and naloxone in urine

 

Chain of custody is required whenever the results of testing could be used in a court of law. Its purpose is to protect the rights of the individual contributing the specimen by demonstrating that it was under the control of personnel involved with testing the specimen at all times; this control implies that the opportunity for specimen tampering would be limited.

Additional Tests
Lists tests that are always performed, at an additional charge, with the initial tests.

Test Id Reporting Name Available Separately Always Performed
COCH Chain of Custody Processing No Yes
ADLTX Adulterants Survey, CoC, U Yes Yes

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Adulterants testing will be performed on all chain of custody urine samples as per regulatory requirements.

Method Name
A short description of the method used to perform the test

Immunoassay followed by Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Opiate Confirmation, CoC, U

Aliases
Lists additional common names for a test, as an aid in searching

Codeine

Dilaudid (Hydromorphone)

Heroin (as Morphine)

Hycodan (Hydrocodone)

Hydrocodone (Hycodan, Vicodin)

Hydromorphone (Dilaudid, Vicodin)

Lortab (Hydromorphone)

Morphine

Opiates

Oxycodone (Oxycontin, Percodan)

Oxycontin (Oxycodone)

Percodan (Oxycodone)

Vicodin (Hydrocodone)

Dihydrocodeine (DHC Plus, Panlor DC, Synalgos DC)

DHC Plus (Dihydrocodeine)

Naloxone (Narcan)

Narcan (Naloxone)

Noroxymorphone

Noroxycodone

Panlor DC (Dihydrocodeine)

Synalgos DC (Dihydrocodeine)

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Adulterants testing will be performed on all chain of custody urine samples as per regulatory requirements.

Specimen Type
Describes the specimen type validated for testing

Urine

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Supplies: Chain-of-Custody Kit (T282)

Container/Tube: Chain-of-custody kit containing the specimen containers, seals, and documentation required.

Specimen Volume: 5 mL

Collection Instructions: Collect urine specimen in the container provided, seal, and submit with the associated documentation to satisfy the legal requirements for chain-of-custody testing.

Additional Information: Submitting less than 5 mL will compromise our ability to perform all necessary testing.

Forms

1. Chain of Custody Request is included in the Chain-of-Custody Kit (T282).

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

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

2 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis OK
Gross icterus OK

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Urine Refrigerated (preferred) 28 days
Frozen 28 days
Ambient 14 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

Detection and quantification of codeine, hydrocodone, oxycodone, morphine, hydromorphone, oxymorphone, noroxycodone, noroxymorphone, norhydrocodone, dihydrocodeine, and naloxone in urine

 

Chain of custody is required whenever the results of testing could be used in a court of law. Its purpose is to protect the rights of the individual contributing the specimen by demonstrating that it was under the control of personnel involved with testing the specimen at all times; this control implies that the opportunity for specimen tampering would be limited.

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Adulterants testing will be performed on all chain of custody urine samples as per regulatory requirements.

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Codeine is converted by hepatic metabolism to morphine and norcodeine with a half-life of 2 to 4 hours. If codeine is ingested, the ratio of codeine to morphine generally exceeds 1.0 in urine during the first 24 hours. The ratio may fall below 1.0 after 24 hours; and after 30 hours, only morphine may be detected.

 

Morphine is a naturally occurring narcotic analgesic obtained from the poppy plant, Papaver somniferum. Morphine is converted by hepatic metabolism to normorphine with a half-life of 2 to 4 hours. The presence of morphine in urine can indicate exposure to morphine, heroin, or codeine within 2 to 3 days. Ingestion of bakery products containing poppy seeds can also cause morphine to be excreted in urine. If excessively large amounts are consumed, this can result in urine morphine concentrations up to 2000 ng/mL for a period of 6 to 12 hours after ingestion.

 

Hydrocodone exhibits a complex pattern of metabolism including O-demethylation, N-demethylation, and 6-keto reduction to the 6-beta hydroxymetabolites. Hydromorphone and norhydrocodone are both metabolites of hydrocodone. Dihydrocodeine is also a minor metabolite. Trace amounts of hydrocodone can also be found in the presence of approximately 100-fold higher concentrations of oxycodone or hydromorphone since it can be a pharmaceutical impurity in these medications. The presence of hydrocodone greater than 100 ng/mL indicates exposure within 2 to 3 days prior to specimen collection.

 

Hydromorphone is metabolized primarily in the liver and is excreted primarily as the glucuronidated conjugate, with small amounts of parent drug and minor amounts of 6-hydroxy reduction metabolites. The presence of hydromorphone greater than 100 ng/mL indicates exposure within 2 to 3 days prior to specimen collection. Hydromorphone is also a metabolite of hydrocodone; therefore, the presence of hydromorphone could also indicate exposure to hydrocodone.

 

Dihydrocodeine is a semisynthetic narcotic analgesic prepared by the hydrogenation of codeine. It is also a minor metabolite of hydrocodone. It is metabolized to dihydromorphine and has a half-life of 3.4 to 4.5 hours.

 

Oxycodone is metabolized to noroxycodone, oxymorphone, and their glucuronides and is excreted primarily via the kidney. The presence of oxycodone greater than 100 ng/mL indicates exposure to oxycodone within 2 to 3 days prior to specimen collection.

 

Oxymorphone is metabolized in the liver to noroxymorphone and excreted via the kidney primarily as the glucuronide conjugates. Oxymorphone is also a metabolite of oxycodone and, therefore, the presence of oxymorphone could also indicate exposure to oxycodone.

 

Naloxone is a synthetic narcotic antagonist and used for partial or complete reversal of opioid depression induced by natural or synthetic opioids. It has also been incorporated into oral tablets of opioids to discourage abuse. The duration of action is dependent on the dose and route of administration. The half-life in adults is approximately 30 to 81 minutes.

 

The detection interval for the opiates is generally 2 to 3 days after last ingestion.

 

Chain of custody is a record of the disposition of a specimen to document each individual who collected, handled, and performed the analysis. When a specimen is submitted in this manner, analysis will be performed in such a way that it will withstand regular court scrutiny.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Negative

Cutoff concentrations:

 

IMMUNOASSAY SCREEN

300 ng/mL

 

Liquid chromatography-tandem mass spectroscopy:

Codeine: 25 ng/mL

Dihydrocodeine: 25 ng/mL

Hydrocodone: 25 ng/mL

Norhydrocodone: 25 ng/mL

Hydromorphone: 25 ng/mL

Oxycodone: 25 ng/mL

Noroxycodone: 25 ng/mL

Oxymorphone: 25 ng/mL

Noroxymorphone: 25 ng/mL

Naloxone: 25 ng/mL

Morphine: 25 ng/mL

Interpretation
Provides information to assist in interpretation of the test results

This procedure reports the total urine concentration; this is the sum of the unconjugated and conjugated forms of the parent drug.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

This test detects drugs structurally similar to morphine. Other drugs in the opioid class, such as fentanyl, meperidine, and methadone are not detected.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. 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; 2006:chap 21

2. Baselt RC: Disposition of Toxic Drugs and Chemical in Man. 9th ed. Biomedical Publications; 2011

3. Hackett LP, Dusci LJ, Ilett KF, Chiswell GM: Optimizing the hydrolysis of codeine and morphine glucuronides in urine. Ther Drug Monit. 2002;24(5):652-657

4. Langman LJ, Bechtel LK, Meier BM, Holstege C: Clinical Toxicology. In: Rifai N, Horvath AR, Wittwer CT, eds. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. 6th ed. Elsevier; 2018:832-887

Method Description
Describes how the test is performed and provides a method-specific reference

Opiates exist in patient urine as both free and either sulfate or glucuronide conjugates. Specimens are initially screened by immunoassay. The opiate assay is 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.

The NADH formed during the reaction, measured photometrically as a rate of change in absorbance, is directly proportional to the ethyl alcohol concentration.(Package insert: Opiates. Roche Diagnostics; 11/2017)

 

After screening, enzyme hydrolysis is used to liberate the conjugated drug. Specimens are then centrifuged, diluted, and the analytes are separated by liquid chromatography-tandem mass spectroscopy and analyzed by multiple reaction monitoring.(Unpublished Mayo method)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Friday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

2 to 4 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

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

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

80361

80365

G0480 (if appropriate)

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
OPATX Opiate Confirmation, CoC, U In Process
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
6541 Opiates Immunoassay Screen 70151-6
36213 Codeine-by LC-MS/MS 16250-3
36214 Hydrocodone-by LC-MS/MS 16252-9
36215 Hydromorphone-by LC-MS/MS 16998-7
36216 Oxycodone-by LC-MS/MS 16249-5
36212 Oxymorphone-by LC-MS/MS 17395-5
36217 Morphine-by LC-MS/MS 16251-1
36218 Opiates Interpretation 18390-5
36219 Chain of Custody 77202-0
42005 Dihydrocodeine-by LC-MS/MS 19448-0
42006 Norhydrocodone-by LC-MS/MS 61422-2
42007 Noroxycodone-by LC-MS/MS 61425-5
42008 Noroxymorphone-by LC-MS/MS 90894-7
42009 Naloxone-by LC-MS/MS 77207-9

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports