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Test Code OPTMX Opiate Confirmation, Chain of Custody, Meconium

Useful For

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

Test ID Reporting Name Available Separately Always Performed
COCH Chain of Custody Processing No Yes

Reporting Name

Opiate Confirmation, CoC, M

Specimen Type

Meconium


Specimen Required


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.


Specimen Minimum Volume

0.3 g (approximately 1/4 teaspoon)

Specimen Stability Information

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

Reject Due To

Grossly bloody Reject; Pink OK

Clinical Information

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

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

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

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

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

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)

Day(s) Performed

Monday through Sunday

Report Available

2 to 3 days

Specimen Retention Time

2 weeks

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

80361

80365

G0480 (if appropriate)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
OPTMX Opiate Confirmation, CoC, M 69026-3

 

Result ID Test Result Name Result LOINC Value
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

Method Name

Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS)

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.