Dataset Information

Multi-laboratory validation of a ?9-tetrahydrocannabinol LC-MS/MS test kit designed for quantifying THC and marijuana metabolites in blood.

ABSTRACT: Marijuana legalization has increased the demand for testing of ?9-tetrahydrocannabinol (THC) and THC metabolites. The THC ToxBox® test kit (THC ToxBox®) is commercially available and supports high-throughput LC-MS/MS analytical methods designed to quantify low levels of THC and THC metabolites in blood. The purpose of this study is to determine if this new test kit meets the rigors of laboratory accreditation and produces equivalent results across six states- and locally-funded laboratories. Each laboratory followed internal method validation procedures established for their clinical (CLIA) or international (ISO17025) accreditation program. Test performance indicators included accuracy, precision, measurement of uncertainty, calibration models, reportable range, sensitivity, specificity, carryover, interference, ion suppression/enhancement and analyte stability. Analytes and interferents were resolved within the 6-min analytical runtime, and the 48-well plate pre-manufactured with calibrators, second source quality control material, and internal standards at precise concentrations allowed for simple and consistent sample preparation in less than one hour. Every laboratory successfully validated test kit procedures for forensic use. Differences in sensitivity were generally associated with the use of older equipment. Statistical analysis of results spanning reportable ranges show that laboratories with different instrument platforms produce equivalent results at levels sufficiently low enough to support per se limit testing of THC and THC metabolites (1-5 ng/mL). THC ToxBox® represents a viable option for state- and locally-funded laboratories charged with investigating impaired driving cases involving marijuana use.

SUBMITTER: Patton AL

PROVIDER: S-EPMC6016857 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Publications

Multi-laboratory validation of a Δ9-tetrahydrocannabinol LC-MS/MS test kit designed for quantifying THC and marijuana metabolites in blood.

Patton Amy L AL Jones Joseph O JO Nord Anne A Eversole D W DW Feazell Erin E EE Mauldin Kristen K Li Lingyun L Williams Lee D LD Bai Shasha S Channell Kermit K Endres Gregory G Gamette Matthew M Moran Jeffery H JH

Forensic science and criminology 20180328 1

Marijuana legalization has increased the demand for testing of Δ9-tetrahydrocannabinol (THC) and THC metabolites. The THC ToxBox<sup>®</sup> test kit (THC ToxBox<sup>®</sup>) is commercially available and supports high-throughput LC-MS/MS analytical methods designed to quantify low levels of THC and THC metabolites in blood. The purpose of this study is to determine if this new test kit meets the rigors of laboratory accreditation and produces equivalent results across six states- and locally-fu ...[more]

PMID: 29955732

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Project description:Delta-9-tetrahydrocannabinol (?9-THC) is a naturally occurring psychoactive compound derived from the hemp plant Cannabis sativa. In 2015, EFSA established an acute reference dose (ARfD) of 1 ?g/kg body weight (bw) for ?9-THC and assessed acute dietary exposure from milk and dairy products. This resulted at the most 3% and 13% of the ARfD for adults and toddlers, respectively. Following the European Commission Recommendation 2016/2115 on the monitoring of the presence of ?9-THC in food and the issuing of a new mandate, EFSA assessed the acute human exposure to ?9-THC. 'Standard' food categories were used as proxies for consumption of hemp and hemp-based products. Twelve independent scenarios based on single food categories were considered and acute exposure was assessed for consumption days only for all age groups excluding infants. Occurrence data for Total-?9-THC (588 samples in total) were used for this assessment up to the highest reliable percentile for each food category. The EFSA ARfD of 1 ?g/kg bw was exceeded in the adult high consumers of most considered hemp and hemp-containing products, under the lower-bound (LB) and upper-bound (UB) scenario. At the UB, acute exposure in adult high consumers was estimated based on the highest reliable percentile of occurrence, for Hemp seeds (P95, up to 9 ?g/kg bw), Hemp oil (P95, up to 21 ?g/kg bw), Tea (Infusion) (P95, up to 208 ?g/kg bw), Breakfast cereals (P50, up to 1.3 ?g/kg bw), Pasta (Raw) (P75, up to 6.4 ?g/kg bw), Bread and rolls (P75, up to 1.3 ?g/kg bw), Bread and rolls from hemp flour (P90, up to 4.1 ?g/kg bw), Cereal bars (P50, up to 0.3 ?g/kg bw), Fine bakery wares (P75, up to 5.1 ?g/kg bw), Chocolate (Cocoa) products (P75, up to 1.1 ?g/kg bw), Energy drinks (P75, up to 0.2 ?g/kg bw), Dietary supplements (P75, up to 9.9 ?g/kg bw), Beer and beer-like beverages (P90, up to 41 ?g/kg bw). The use of proxies for the consumption of hemp and hemp-containing products, the limited number of occurrence data and the analytical limitations in the quantification of ?9-THC represent the most important sources of uncertainty. Overall, exposure estimates presented in this report are expected to represent an overestimation of acute exposure to ?9-THC in the EU.

Dataset Information

Multi-laboratory validation of a ?9-tetrahydrocannabinol LC-MS/MS test kit designed for quantifying THC and marijuana metabolites in blood.

Publications

Multi-laboratory validation of a Δ9-tetrahydrocannabinol LC-MS/MS test kit designed for quantifying THC and marijuana metabolites in blood.

Similar Datasets

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