A-114 Mas™ Omni·Core™ Controls, Ready-to-use Tube Format

Abstract

Abstract Background The Thermo Fisher Scientific™ MAS™ Controls* are assayed controls to monitor assay performance within clinical laboratory settings. The user can compare observed results of controls with their expected ranges as a means of assuring consistent performance of both reagent and instrument. The objective of developing MAS™ Ready-to-Use Tube Controls is to provide MAS™ controls in a new automation-friendly plastic tube format, as an alternative to the current glass vials. The MAS™ controls contained in the plastic tubes are intended to be used by core labs to be placed directly onto the analyzers, eliminating the need to aliquot into sample cups or other primary tubes. In this presentation we summarize the results of MAS™ Omni·CORE™ in the new Ready-to-Use Tube Controls configuration. Methods The purpose of these studies is to verify material compatibility and acceptable product performance of MAS™ Omni·CORE™ in the new Ready-to-Use Tube Controls configuration. The controls were also assessed for Fit/Form/Function on various platforms from manufacturers such as Siemens, Roche, Abbott, Ortho Clinical Diagnostics, Thermo Fisher Scientific, and Beckman. Results The MAS™ Omni·CORE™ Ready-to-Use Control results demonstrated comparable performance and Fit/Form/Function criterion of the specified platforms. Torque/Leak, Cap Characterization, and Plastic Interaction studies yielded passing results per protocol criterion. The In-Use (CO2) study demonstrated acceptable “time-on-platform” performance of 9 h in 2–8°C (4 h at 25°C). The Extractables/Leachables study demonstrated passing results for all claimed analytes, with minor exceptions. All light sensitive analytes yielded passing results during the Light Transmission study. Conclusion To conclude, the MAS™ Omni·CORE™ Ready-to-Use Controls will contribute to the increased efficiency of core lab workflow by allowing the analyzer(s) to aspirate controls directly from the tube and allow for control storage in an on-board refrigeration unit after use. *Availability of product in each country depends on local regulatory marketing authorization status.