USDTL Urine Toxicology (Maternal)🔗

Name

USDTL Urine Toxicology (Maternal) (Urine)

Table Namebio_bm_biosample_urine_results
Construct

Drug Panel, Toxins

Study Visits

V01

TypeIn-person Biospecimen collection (Parent on Self; 5 min)
Quality Control

Examine assay ranges and categorical versus continuous measures
USDTL Screening Updates

As of May 19, 2025, USDTL transitioned the initial urine screening test for fentanyl and sufentanil from LDTD to ELISA. As of November 2025, urine samples were no longer assayed for sufentanil, and USDTL simplified its specimen validity assessment, replacing a multi-parameter algorithm (including pH and nitrite) with a single creatinine-based measure to evaluate urine hydration.

Continuous Variables

Continuous variables should be interpreted with caution based on limits of quantification (LOQ), i.e. the minimum concentration at which metabolites can be reliably quantified. See Urine Assay Thresholds for Analytes.

Urinary Concentration Corrections

Urinary concentration varies by participant. Researchers who wish to correct for urinary concentration in continuous measures, or apply different thresholds, can do so using creatinine or specific gravity results from sample validation.

Large Gaps Between Collection and Analysis Dates

A substantial number of samples show unusually long intervals between collection and analysis (e.g., over 100–300 days, compared to the 30-day limit specified by internal SOPs). We are working to determine whether this reflects a data entry or site-level issue and will provide an update once more information is available.

Instrument Details🔗

Urine toxicology assay results include:

  • Screening results: initial screening results for substances (e.g. Amphetamine/s_amp_u), determined to be positive/negative based on predefined thresholds, or invalid based on Validation Procedures (see details below)
  • Confirmatory results: confirm positive screening results for a given substance analyte, e.g. Amphetamine, including continuous (c_amp_u) and categorical (c_amp_u_cat) results
  • Classification: results are grouped into different classes based on analyte screening and confirmatory tests (see Mapping From Class to Screening & Confirmatory Tests).

Urine toxicology processing workflow

Validation Procedures🔗

Assay results may be scored as invalid if specimens are identified as dilute, substituted, adulterated, or otherwise insufficient based on validation. Validation is based on creatinine, pH, and nitrite measurements, with creatinine analysis repeated to rule out issues with the first analysis (e.g., sample mix-ups, air bubble in a line on the instrument). Specimens with low creatinine (< 20 mg/dL) are confirmed using specific gravity via a refractometer. Decision grid:

Creatinine (mg/dL)Specific Gravity
1.0001.0011.0021.003–1.019≥1.020
0–1.9SubstitutedSubstitutedInvalidInvalidSubstituted
2.0–19.9InvalidInvalidDiluteNormalNormal
>20Normal — Specific Gravity not required
AnalytesUnitLODLOQCutoffDetection Window
2-Hydroxyethylflurazepamng/mL20401001–4 days
6-MAMng/mL24108 hours
7-Aminoflunitrazepam / 7-Aminoclonazepam / 7-Aminonitrazepamng/mL20401001–4 days
α-Hydroxyalprazolam / α-Hydroxymidazolam / α-Hydroxytirazolamng/mL20401001–4 days
Amphetamine / Methamphetamineng/mL501002502–3 days
Amobarbital / Butalbitalng/mL401002002–4 days
Benzoylecgonineng/mL20501002–3 days
Buprenorphine / Norbuprenorphineng/mL1252–3 days
Carboxy-delta-9-THCng/mL37.515Casual: 2–5; Chronic: 10–14 days
Carboxy-delta-8-THCng/mL37.515No consensus
Carboxy-cannabidiolng/mL102550No consensus
Carisoprodolng/mL1020502–3 days
Codeine / Hydrocodoneng/mL10501002–3 days
Cotinineng/mL3434500Up to 7 days
EDDPng/mL601203002–3 days
Ethyl glucuronideng/mL501001002–3 days
Ethyl sulfateng/mL12.525252–3 days
Fentanyl / Norfentanyl / Alfentanil / Sufentanilpg/mL40401002–3 days
Hydromorphone / Morphineng/mL10501002–3 days
Ketamine / Norketamineng/mL10501002–3 days
Lorazepam / Nordiazepam / Oxazepam / Temazepamng/mL20401001–4 days
MDA / MDMA / MDEAng/mL501002502–3 days
Meprobamateng/mL1020502–3 days
Methadoneng/mL601203002–3 days
Normeperidineng/mL401002002–3 days
Norpropoxypheneng/mL10501002–3 days
Oxycodone / Oxymorphoneng/mL601203002–3 days
Pentobarbital / Secobarbitalng/mL401002001–2 days
Phenobarbitalng/mL401002002 weeks
Phencyclidineng/mL512.5252–3 days
Tramadolng/mL40802002–3 days
Zolpidem / Zolpidem Carboxylic Acidng/mL48202–3 days

Final results for each substance follow these rules:

  • Positive results: If any confirmatory test for a substance analyte (e.g., Amphetamine/c_amp_u) is positive, then the corresponding class-level (c_any_stim_u) and overall sample-level (c_any_specimen_u) results are also positive.
  • Negative results: If all confirmatory tests for analytes in a class are negative (e.g., c_ethglu_u, c_ethsyl_u), then the class-level result (e.g., c_etgeia_u) is negative. If all classes are negative, the overall sample-level (c_any_specimen_u) result is negative.
  • Invalid results: If any confirmatory test for a substance analyte is invalid, then the corresponding class-level and overall sample-level results are also invalid.
Level Result Type Example Options
Specimen Confirmatory results (presence of any analyte) c_any_specimen_u 1=positive
0=negative
3=invalid
Class Confirmatory results (presence of any analyte in class)c_any_stim_u
AnalyteScreening resultss_amp_u
Confirmatory resultsc_amp_uconcentration value
Confirmatory results - categoricalc_amp_u_cat⁠1 1=positive
0=negative
3=invalid
4=screen negative
1Note: the categorical confirmatory test variable for nicotine follows the convention c_nicotine_u

Sullivan, E. L., Bogdan, R., Bakhireva, L., Levitt, P., Jones, J., Sheldon, M., Croff, J. M., Thomason, M., Lo, J. O., MacIntyre, L., Shrivastava, S., Cioffredi, L.-A., Edlow, A. G., Howell, B. R., Chaiyachati, B. H., Lashley-Simms, N., Molloy, K., Lam, C., Stoermann, A. M., … HBCD Biospecimens Workgroup. (2024). Biospecimens in the HEALthy Brain and Child Development (HBCD) study: Rationale and protocol. Developmental Cognitive Neuroscience, 70(101451), 101451. https://doi.org/10.1016/j.dcn.2024.101451