Validation of an Automated Assay for Levetiracetam (Keppra) on Vitros 5600

Objective: Levetiracetam (also known as Keppra™) is an antiepileptic drug that has been demonstrated as an effective adjunctive therapy in the treatment of partial onset of seizures, primary generalized tonic-clonic seizures, and myoclonic seizures. The aim of our study was to validate an automated quantitative immunoassay for levetiracetam at Texas Children's Hospital. Method: We validated the analytical performance of ARK™ Levetiracetam Assay on an Ortho Clinical Diagnostic Vitros 5600 Analyzer at Texas Children's Hospital. Analytical performance parameters included precision, linearity, sensitivity, accuracy, and effect of common interferents (free hemoglobin, bilirubin, triglycerides). We also tested common drug interferents on the ARK Levetiracetam Assay. Results: The assay showed good precision with <4% coefficient of variation (%CV) for intraassay and <7% for interassay precision, respectively. The assay was linear across the measurement range (0.0-100.00 μg/mL). No significant effect was seen with common interferents or commonly co-used drugs. Conclusions: The ARK Levetiracetam Assay on Ortho Clinical Diagnostic Vitros 5600 can be used for routine determination of levetiracetam for conducting therapeutic drug monitoring and optimizing individual dosage regimen.