Test Catalog

Test Id : OPTMX

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Opiate Confirmation, Chain of Custody, Meconium

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Overview

Test Catalog

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

Detecting maternal prenatal opiate/opioid use up to 5 months before birth

 

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. Since the evidence of illicit drug use during pregnancy can be cause for separating the baby from the mother, a complete chain of custody ensures that the test results are appropriate for legal proceedings.

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

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

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, M

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)

Vicodin (Hydrocodone)

Specimen Type
Describes the specimen type validated for testing

Meconium

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

Supplies: Chain of Custody Meconium Kit (T653) includes the specimen containers, seals, and documentation required.

Specimen Volume: 1 g (approximately 1 teaspoon)

Collection Instructions: Collect entire random meconium specimen.

Additional Information:

1. Specimen that arrives with a broken seal does not meet the chain of custody requirements.

2. The laboratory recommends sending chain-of-custody specimens by overnight shipment.

Forms

1. Chain of Custody Request is included in the Chain-of-Custody Meconium Kit (T653).

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

0.3 g (approximately 1/4 teaspoon)

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

Grossly bloody Reject; Pink 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
Meconium Frozen (preferred) 28 days
Refrigerated 28 days
Ambient 14 days

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

Detecting maternal prenatal opiate/opioid use up to 5 months before birth

 

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. Since the evidence of illicit drug use during pregnancy can be cause for separating the baby from the mother, a complete chain of custody ensures that the test results are appropriate for legal proceedings.

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

Opiates are naturally occurring alkaloids that are derived from the opium poppy and demonstrate analgesic effects. Opioids are derived from natural and semisynthetic alkaloids of opium or synthetic compounds(1):

-Codeine is a naturally occurring opioid agonist often incorporated into formulations along with acetaminophen or aspirin to increase its analgesic effect.(2) Codeine is metabolized to morphine and subsequently undergoes glucuronidation and sulfation.

-Morphine is an opioid receptor agonist used for major pain analgesia.(2) It has been shown to distribute widely into many fetal tissues(3) and has been detected in meconium.

-Hydrocodone is a semisynthetic analgesic derived from codeine. Hydrocodone is 6 times more potent than codeine and is prescribed for treatment of moderate-to-moderately severe pain.(2) Hydrocodone undergoes O-demethylation in vivo, forming hydromorphone.

-Hydromorphone, a semisynthetic derivative of morphine, is an opioid analgesic. It is 7 to 10 times more potent than morphine, its addiction liability is similar to morphine.(2)

-Oxycodone, a semisynthetic narcotic derived from thebaine. It is metabolized by O-demethylation, forming oxymorphone.(2)

-Oxymorphone is a semisynthetic opioid derivative of thebaine and is indicated for moderate-to-severe pain.(2)

-Heroin, a semisynthetic derivative of morphine, is rapidly deacetylated in vivo to the active metabolite 6-monoacetlymorphine (6-MAM), which is further hydrolyzed to morphine.(2)

 

Opiates have been shown to readily cross the placenta and distribute widely into many fetal tissues. Opiate use by the mother during pregnancy increases the risk of prematurity and small size for gestational age. Furthermore, heroin-exposed infants exhibit an early onset of withdrawal symptoms compared to methadone-exposed infants. These infants demonstrate a variety of symptoms including irritability, hypertonia, wakefulness, diarrhea, yawning, sneezing, increased hiccups, jitteriness, excessive sucking, and seizures. Long-term intrauterine drug exposure may lead to abnormal neurocognitive and behavioral development as well as an increased risk of sudden infant death syndrome.

 

The disposition of opiates and opioids in meconium, the first fecal material passed by the neonate, is not well understood. The proposed mechanism is that the fetus excretes drug into bile and amniotic fluid. Drug accumulates in meconium either by direct deposition from bile or through swallowing of amniotic fluid. The first evidence of meconium in the fetal intestine appears at approximately the 10th to 12th week of gestation, and it slowly moves into the colon by the 16th week of gestation. Therefore, the presence of drugs in meconium has been proposed to be indicative of in utero drug exposure during the final 4 to 5 months of pregnancy, a longer historical measure than is possible by urinalysis.

 

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

 

Positives are reported with a quantitative liquid chromatography tandem mass spectrometry (LC-MS/MS) result.

Cutoff concentrations for LC-MS/MS testing:

Codeine: 20 ng/mL

Hydrocodone: 20 ng/mL

Hydromorphone: 20 ng/mL

Morphine: 20 ng/mL

Oxycodone: 20 ng/mL

Oxymorphone: 20 ng/mL

Interpretation
Provides information to assist in interpretation of the test results

The presence of any of the following opiates (codeine, morphine, hydrocodone, hydromorphone, oxycodone, oxymorphone) at 20 ng/g or more or 6-monoacetlymorphine at 10 ng/g or more indicates the newborn was exposed to opiates/opioids during gestation.

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

Since the evidence of illicit drug use during pregnancy can be cause for separating the baby from the mother, a kit is available that includes all the materials necessary to complete chain of custody to ensure test results are appropriate for legal proceedings.

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

2. Baselt RC:. Disposition of Toxic Drugs and Chemical in Man. 10th ed. Biomedical Publications; 2014

3. Szeto HH: Kinetics of drug transfer to the fetus. Clin Obstet Gynecol. 1993;36:246-254

4. Ahanya SN, Lakshmanan J, Morgan BL, Ross MG: Meconium passage in utero: mechanisms, consequences, and management. Obstet Gynecol Surv. 2005;60:45-56

5. 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

Meconium is mixed with internal standard and extracted with methanol. The methanolic extract is further processed by solid phase extraction. The extract is analyzed by liquid chromatography tandem mass spectroscopy.(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 Sunday

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 3 days

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

2 weeks

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 account representative. 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. It 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
OPTMX Opiate Confirmation, CoC, M 69026-3
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.
36221 Morphine 69027-1
36222 Oxymorphone 69028-9
36223 Hydromorphone 68541-2
36224 Codeine 68542-0
36225 Oxycodone 68543-8
36226 Hydrocodone 68544-6
36227 Interpretation 8215-6
36228 Chain of Custody 77202-0

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 | PHP Pdf | CMS 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