B-018 Design and Development of MASTM Diabetes Max Controls, Ready-to-Use Plastic Tube Format

Abstract

Background The Thermo 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. Diabetes Max Control is the first MAS™ product designed and developed in this ready-to-use format to be placed directly on the analyzer. The new format will increase efficiency and allow for on-board refrigerated storage, and it is expected to reduce material loss and contamination. It contains Hemoglobin A1c formulated in whole blood matrix to mimic patient specimens. In this presentation we summarize the Feasibility, Development, Verification, and Validation results of MAS™ Diabetes Max Controls. Methods The performance was assessed by conducting the following studies for MAS™ Diabetes Max Tube Controls. The analyte Hemoglobin A1c was measured in functional studies to evaluate and verify the product performance. Other studies were also designed and performed to assess the product usability. Results MAS™ Diabetes Max Control results demonstrated comparable performance and Fit/Form/Function criterion on specified platforms, particularly the TOSOH™ platform. All feasibility studies provided very promising results passing per protocol criterion. Design Verification and Validation studies ensured product integrity and passed specifications for proposed claims. Process Validation is in progress with data being collected for both Value Assignments and Real Time Stability. Conclusions MAS™ Diabetes Max Controls provided in ready-to-use tubes met the design specification criteria. We believe that MAS™ Diabetes Max 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.