376 Validation of the Lidocaine Syva EMIT™ Assay on the Roche cobas 503 System

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Abstract Introduction/Objective Lidocaine is a class IB antiarrhythmic with a narrow therapeutic index. The lidocaine Syva EMIT™ is a third-party FDA-approved assay adaptable to several automated chemistry platforms. Although assay parameters exist for the Roche cobas c502, they are unavailable for Roche cobas c503. The objective of this study was to establish assay performance characteristics for the c503 platform. Methods/Case Report Assay parameters were customized to the c503 using a validated c502 method. Timed studies for non-premade reagent equilibrium were evaluated at 2 and 24 hours. Calibration and Bio-Rad Immunoassay Plus quality control materials were used to assess the initial assay install. Precision, reportable range, and method comparisons with a Siemens Vista 1500 were then used to validate the method. Results Timed reagent studies showed that 2 hours was minimum time needed for equilibration. Coefficient of variation for all precision studies was <5%. The reportable range of the assay was determined to be 1-12 µg/dL with an extended measuring interval of 1-48 µg/dL. Deming and Passing-Bablok regression statistics demonstrated a slope of 0.996, intercept of -0.10, and correlation coefficient of 0.9903. Conclusion Our data established the performance characteristics of the lidocaine assay on the Roche c503 platform for routine patient testing.

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