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HelpTest ID DSM4X Drugs of Abuse Screen 4, Chain of Custody, Meconium
Useful For
Identifying amphetamines (and methamphetamines), opiates, as well as metabolites of cocaine and marijuana in meconium specimen
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 always under the control of personnel involved with testing the specimen; 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 |
Reflex Tests
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| COKMX | Cocaine and metabolite Conf, CoC, M | Yes | No |
| OPTMX | Opiate Confirmation, CoC, M | Yes | No |
| THCMX | Carboxy-THC Confirmation, CoC, M | Yes | No |
| AMPMX | Amphetamines Confirmation, CoC, M | Yes | No |
Testing Algorithm
Testing begins with immunoassay screen. Positive results are confirmed and quantitated by liquid chromatography tandem mass spectrometry at an additional charge.
Reporting Name
Drugs of Abuse Screen 4, CoC, MSpecimen Type
MeconiumSpecimen Required
Container/Tube: 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
0.45 g (approximately 0.5 teaspoon)
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Meconium | Frozen (preferred) | 21 days | |
| Refrigerated | 21 days | ||
| Ambient | 72 hours |
Reject Due To
| Grossly bloody | Reject, Pink OK |
Clinical Information
Illicit drug use during pregnancy is a major social and medical issue. Drug abuse during pregnancy is associated with significant perinatal complications, which include a high incidence of stillbirths, meconium-stained fluid, premature rupture of the membranes, maternal hemorrhage (abruption placenta or placenta praevia), and fetal distress.(1) In the neonate, the mortality rate, as well as morbidity (eg, asphyxia, prematurity, low birthweight, hyaline membrane distress, infections, aspiration pneumonia, cerebral infarction, abnormal heart rate and breathing problems, and drug withdrawal) are increased.(1)
The disposition of drug in meconium 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 deposit from bile or through swallowing of amniotic fluid.(2) The first evidence of meconium in the fetal intestine appears at approximately the 10th to 12th week of gestation and slowly moves into the colon by the 16th week of gestation.(3) Therefore, the presence of drugs in meconium has been proposed to be indicative of in utero drug exposure up to 5 months before birth, a longer historical measure than is possible by urinalysis.(2)
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
Positive results are reported with a quantitative liquid chromatography tandem mass spectrometry result.
Cutoff concentrations by competitive chemiluminescent immunoassay:
Amphetamines: 100 ng/g
Methamphetamine: 100 ng/g
Benzoylecgonine (cocaine metabolite): 100 ng/g
Opiates: 100 ng/g
Tetrahydrocannabinol carboxylic acid (marijuana metabolite): 20 ng/g
Interpretation
The limit of quantitation varies for each of these drug groups.
-Amphetamines: >100 ng/g
-Methamphetamines: >100 ng/g
-Cocaine and metabolite: >100 ng/g
-Opiates: >100 ng/g
-Tetrahydrocannabinol carboxylic acid: >20 ng/g
Cautions
No significant cautionary statements
Clinical Reference
1. Ostrea EM Jr. Understanding drug testing in the neonate and the role of meconium analysis. J Perinat Neonatal Nurs. 2001;14(4):61-82; quiz 105-106
2. Ostrea EM Jr, Brady MJ, Parks PM, Asensio DC, Naluz A. Drug screening of meconium in infants of drug-dependent mothers: an alternative to urine testing. J Pediatr. 1989;115(3):474-477
3. Ahanya SN, Lakshmanan J, Morgan BL, Ross MG. Meconium passage in utero mechanisms, consequences, and management. Obstet Gynecol Surv. 2005;60(1):45-56; quiz 73-74
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
5. Langman LJ, Rushton AM, Thomas D, et al. Drug testing in support of the diagnosis of neonatal abstinence syndrome: The current situation. Clin Biochem. 2023;111:1-10. doi:10.1016/j.clinbiochem.2022.11.002
6. Marin SJ, Merrell M, McMillin GA. Drugs of abuse detection in meconium: a comparison between ELISA and biochip microarray. J Anal Toxicol. 2011;35(1):40-45. doi:10.1093/anatox/35.1.40
Method Description
The meconium sample received is screened by competitive chemiluminescent immunoassay by Randox Evidence+ to detect the presence of any of the drugs or drugs that cross react with amphetamine, methamphetamine, cocaine metabolite, opiates, and carboxy-tetrahydrocannabinol. Meconium specimens identified as positive by this screen are analyzed using liquid chromatography tandem mass spectroscopy for the specific drug or drug class indicated.
Day(s) Performed
Monday through Saturday
Report Available
1 to 2 daysTest 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
80307
80324 (if appropriate)
80359 (if appropriate)
80353 (if appropriate)
80361 (if appropriate)
80365 (if appropriate)
80349 (if appropriate)
NY State Approved
YesMethod Name
Competitive Chemiluminescent Immunoassay (CIA)
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.