Only a short time after introducing its newly developed and validated tapentadol assay, Dominion Diagnostics (Dominion) is pleased to announce an important enhancement to another clinical laboratory test.
For its pain management clients, Dominion has refined its laboratory testing procedure for the opioid medication fentanyl. Dominion has now lowered the limit of quantification (LOQ) for the primary metabolite, norfentanyl, to 1 ng/mL. Like many of the other assays Dominion provides for clients, this testing procedure is performed by ultra performance liquid chromatography tandem mass spectrometry (UPLC®-MS/MS).
The synthetic opioid fentanyl undergoes extensive metabolism, with only 0.4-6.0% eliminated in the urine as unchanged drug and as much as 55% excreted as the primary metabolite, norfentanyl. Metabolism and excretion studies have also shown that norfentanyl can be detected in the urine of patients approximately three times longer than that of the parent compound(1). As a result of the increased availability of norfentanyl in the urine, as well as the expanded window of detection, Dominion has lowered the LOQ of norfentanyl, thereby increasing the overall analytical sensitivity of the testing procedure.
"As part of Dominion's quality assurance program, our laboratory managers and directors regularly review each assay's performance specifications and make modifications as needed," said Assistant Laboratory Director, Charlene Johnson, Ph.D. "Our goal is to provide clients with scientifically sound and accurate results using the most reliable and up-to-date methods."
The demand for clinical monitoring using highly sensitive and specific clinical laboratory procedures continues to grow, especially as the industry begins to face the FDA's new Risk Evaluation and Mitigation Strategy (REMS). Dominion continues to lead the industry in its development of highly relevant UPLC-MS/MS procedures that assist practitioners in scientifically accurate patient adherence monitoring and chronic opioid pharmacotherapy.