Topic: Tox / TDM / Endocrine
Podium Presentation in Room 1 on Wednesday at 9:40 (Chair: Stephen Roper / Scott Borden)
Authors: Nicholas Laude (1), Bill Edgemond (1)
As the demand for toxicology testing increases in clinical, forensic, and employment settings, the need for high-throughput screening methodologies that are more cost-effective and robust than immunoassays is greater than ever. Toxicology screening using high-resolution accurate-mass systems is a potential solution, but one that may be cost prohibitive and technically infeasible in many laboratories. We demonstrate the utility and effectiveness of using Vanquish Flex UHPLC platforms combined with LTQ XL and LTQ Velos Pro Ion Trap Mass Spectrometers for delivering superior screening results for 38 drugs and metabolites with analysis times of 2 to 4 minutes, depending on platform
The primary objective of this work was to validate a data-dependent LC-MS/MS method for drug screening in clinical specimens using a ion trap mass analyzer.
A month-long study was conducted in which 1828 urine specimens were analyzed using the ion-trap screening (ITS) method. Of these, 824 received laboratory enzyme immunoassay (EIA) testing using a chemistry analyzer, 720 specimens received point of care testing (POCT). All specimens were analyzed using a comprehensive LC-MS/MS confirmation panel to provide a gold standard confirmation results against which the various screening methods were compared
The findings indicate the inadequacy of presumptive drug testing and the inability of POC tests or laboratory EIA to provide reliable drug tests results to health care providers that need to know what substances their patients are taking. The false negative rates for ITS, EIA, and POCT are 6.35%, 12.99%, and 25.69%, respectively. The false positive rates for ITS, EIA, and POCT are 0.44%, 12.14%, and 23.61%, respectively. Specimens having 1 or more error of any type were observed at the following rates for each screening method: ITS 6.78%, EIA 21.84%, POCT 40.97%.
Ion Trap Screening compared well against the LC-MS/MS confirmation results for 1828 specimens, with less than 6.8% of specimens having a false result. Furthermore, 93.22% of specimens receiving ion trap screening showed 100% agreement with the LC-MS/MS confirmation results for 38 drugs and metabolites in 11 distinct drug classes. The data summarized in this report suggest that ion trap screening is a superior method for urine drug screening than enzyme immunoassay performed in a laboratory using a chemistry analyzer or a point of care test.
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