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Our objective was to evaluate whether cannabis use was associated with nausea and vomiting in early pregnancy. Participants from nuMoM2b (Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be) enrolled from October 2010 through September 2013 with a PUQE (Pregnancy-Unique Quantification of Emesis) questionnaire and an available stored urine sample from the first study visit (median gestational age 12 weeks) were included. Cannabis exposure was ascertained by urine immunoassay for 11-nor-9-carboxy-delta-9-tetrahydrocannabinol (THC-COOH); positive results were confirmed with liquid chromatography tandem mass spectrometry. The primary outcome was moderate-to-severe nausea by the PUQE score. Overall, 9,250 participants were included, and 5.8% (95% CI 5.4-6.3%) had detectable urine THC-COOH. In adjusted analyses, higher THC-COOH levels were associated with greater odds of moderate-to-severe nausea (20.7% in the group with THC-COOH detected vs 15.5% in the group with THC-COOH not detected, adjusted odds ratio 1.6, 95% CI 1.1-2.2 for a 500 ng/mg Cr THC-COOH increment).

Context.--Consequences related to nicotine (NIC) use remain a major health concern, leading to demand for testing to detect NIC, metabolites such as cotinine (COT), and related tobacco alkaloids, including anabasine (ANAB). NIC-related testing is not standardized among laboratories, nor are there clinical or regulatory guidelines to inform decisions such as appropriate screening cutoffs or limits of quantitation. Objective.--To evaluate analytical performance and reporting practices of laboratories that perform NIC-related testing by reviewing participant responses to the Nicotine and Tobacco Alkaloid (NTA) Proficiency Testing Survey. Design.--NTA results were retrieved from 2017 (the first year of the survey) through 2020. Survey participants, methodologies, and results were evaluated for all analytes, and simulated grading was performed for COT. Additional data, including limits of quantitation, qualitative cutoffs, and reasons for testing, were reviewed. Results.--Participant growth was steady for qualitative COT testing. Participation was stable for NIC, ANAB, and quantitative COT testing. Overall, participants performed well on survey challenges. However, reporting thresholds were widely divergent, ranging from 10 to 3000 ng/mL and 0.5 to 300 ng/mL, respectively, for qualitative and quantitative COT testing. Screening cutoffs were as high as 100 ng/mL for ANAB and 1000 ng/mL for NIC. Conclusions.--Although participating laboratories performed well on the NTA Survey, the wide diversity of qualitative and quantitative reporting thresholds creates substantial risk for misinterpretation of results, and could lead to analytical concerns such as excessively high falsenegative or false-positive rates. NIC-related testing would benefit from evidence-based guidelines to drive standardization of reporting. (Arch Pathol Lab Med. 2023;147:634-642; doi: 10.5858/arpa.2022-0094-CP), Cigarettes and other products containing nicotine (NIC) remain a significant public health issue, with well-characterized harmful effects on the respiratory, cardiovascular, and other organ systems. (1) In addition to traditional [...]

Background: About 95% of consumed ethanol is metabolized by oxidative pathways. Less than 1% is metabolized via nonoxidative pathways: glucuronidation, sulfation, and the formation of fatty acid esters of ethanol. In neonates, the glucuronidation pathway has been reported to be underdeveloped but matures with age. This work compared the test results of patients' random urine samples submitted to our facility for ethyl glucuronide (EtG) and ethyl sulfate (EtS) measurements across pediatric and adult populations. Methods: Test results (n = 63 498) from urine samples tested for EtG and EtS by quantitative liquid chromatography-tandem mass spectrometry at our facility were utilized for this study. EtG and EtS concentrations were compared across the age partitions 0 to 17 years (pediatric), 18 to 80 years (adult), and 81 to 100 years (geriatric). Eight pediatric patients from a tertiary academic hospital contributed clinical context via abstracted clinical information. Results: Across the individual age partitions, 60% to 65% of patients had both EtG and EtS present in urine. Approximately 5% to 10% of patients had only EtG, and 25% to 35% had neither metabolite present. The lowest percentages (<1.5%) had EtS present in the absence of EtG. Markedly, no pediatric patients had only EtS present; compared to the adult population, this was statistically significant (Fisher exact test, P = 0.025). Conclusions: From the data presented in this work, EtG is more prevalent relative to EtS in urine samples of patients assessed for ethanol exposure. [ABSTRACT FROM AUTHOR]

Context.--As pharmacogenetic testing is incorporated into routine care, it is essential for laboratories to provide accurate and consistent results. Certified laboratories must successfully complete proficiency testing. Objectives.--To understand and examine trends in participation and performance of laboratories participating in the College of American Pathologists pharmacogenetic proficiency testing surveys. Design.--Results from College of American Pathologists pharmacogenetic proficiency testing challenges from 2012 through 2017 were reviewed for concordance with expected genotype and phenotype for each sample (intended responses). Results.--Laboratories correctly reported results for 96.7% to 100% of samples with no variants. Excluding CYP2D6, laboratories correctly detected and reported variant alleles for each gene (93.7%-99.2% correct). CYP2D6 showed lower concordance, with 83.1% of laboratories reporting the intended genotype across all samples; however, in many cases, the laboratories that did not report a variant allele did not test for that allele. Among laboratories reporting the intended genotype, most successfully reported the intended phenotype (85.9%99.0%). Conclusions.--Although laboratories are generally performing well, there is room for additional improvement, particularly for challenging genes, such as CYP2D6. Efforts in the field of pharmacogenomics to recommend alleles that should be included in clinical tests, identify reference materials, and standardize translation from genotype to phenotype may address some of the remaining variability in results. (Arch Pathol Lab Med. 2020;144:1057-1066; doi: 10.5858/arpa.2019-0478-CP), The application of genetic data to inform drug and dose selection decisions, known as pharmacogenetics (PGx), has received a growing level of attention from patients, wellness proponents, payers, regulatory bodies, [...]

* Context.--Urine drug testing is frequently ordered by health care providers. Immunoassays are widely used for drug testing, yet have potential limitations, including variable cross-reactivity. The last decade has seen worsening of a prescription drug abuse epidemic. Objective.--To use data from a College of American Pathologists proficiency testing survey, Urine Drug Testing, Screening, to determine and summarize the characteristics, performance, and limitations of immunoassays. Design.--Seven years of proficiency surveys were reviewed (2011-2017). Results.--Rapid growth was seen in participant volumes for specific immunoassays for synthetic opioids (eg, buprenorphine, fentanyl, oxycodone) and 3,4-methylene-dioxymethamphetamine ('ecstasy'). Participant volumes remained high for immunoassays targeting less commonly abused drugs such as barbiturates and phencyclidine. For opiate immunoassays, the number of laboratories using a 2000 ng/mL positive cutoff remained stable, and an increasing number adopted a 100 ng/mL cutoff. Opiate and amphetamine immunoassays showed high variability in cross-reactivity for drugs other than the assay calibrator. Assays targeting a single drug or metabolite generally performed well on drug challenges. Conclusions.--Survey results indicate strong clinical interest in urine drug testing and some adoption of new assays. However, urine drug testing availability does not parallel prevailing patterns of drug prescribing and abuse patterns. In particular, specific immunoassays for synthetic opioids and a lower positive cutoff for opiate immunoassays may be underused, whereas immunoassays for barbiturates, methadone, propoxyphene, and phencyclidine may be overused. Laboratories are encouraged to review their test menu, cutoffs, and assay performance and adjust their test offerings based on clinical needs and technical capabilities. (Arch Pathol Lab Med. 2020;144:177-184; doi: 10.5858/ arpa.2018-0562-CP), Substance abuse continues to be a significant problem in the United States and other countries. (1,2) In the last 2 decades, nonmedical use of opioids and other prescription medications has [...]

Background: Many low-complexity urine drug screen (UDS) devices are approved by the Food and Drug Administration as waived under Clinical Laboratory Improvement Amendments (CLIA) criteria. Labeling instructs patients to urinate directly into the device and also states that positive results should be confirmed. However, the device itself may pose a risk of drug adsorption and/or specimen contamination that could affect results in confirmatory assays if specimens are reused. Collecting urine in a separate container before performing the UDS would reclassify the test as nonwaived, negating the conveniences of a CLIA-waived test. Also, patients may be unable or unwilling to urinate in an additional container for confirmatory testing. This study examined reusing urine from a UDS device (NexScreen) for confirmatory testing. Methods: 25 patient specimens were pooled and verified to be drug-free. To evaluate drug leaching from the UDS device, 30 mL of this pool was incubated in NexScreen cups, followed by confirmatory testing. To evaluate drug adsorption, 14 representative analytes were spiked slightly over the NexScreen positivity cutoffs, followed by incubation in NexScreen cups and confirmation testing. Results: All negative samples incubated in NexScreen cups remained negative upon confirmation testing, indicating that NexScreen test strips do not contaminate the specimen. For the drug adsorption experiment, 11 of 14 analytes had recoveries of at least 95%, whereas buprenorphine and 11-nor-9-carboxy-tetrahydrocannabinol recovered at 94% and 87%, respectively, suggesting minor adsorption. All analytes recovered above their respective confirmation cutoffs. Conclusions: Urine aliquots from NexScreen cups may be used for confirmatory testing. [ABSTRACT FROM AUTHOR]