Chiron Diagnostics Corporation

Ciba Corning Diagnostics Corp.

Liann Voo

Jay Li

Justin E Davey

David P Swist

Joan B Wilson

Dennis C Tagliaferro

Provided is a method of preparing dye-based reference materials useful for calibrating or qualifying instrument systems that are diagnostic spectroscopically for hemoglobin and CO-ox fractions. The dye-based reference materials are non-proteinaceous and may be interpreted by CO-oximeter instrument systems as providing a spectrum substantially equivalent to the spectrum of blood, particularly with regard to hemoglobin and hemoglobin CO-ox fractions. Dye-based reference materials may be formulated to provide CO-ox fractions approximating those seen in a clinical setting, including normal physiological CO-ox fractions. The dye-based reference materials may be combined with other ingredients thus making the materials useful as references for pH and blood gas instruments and/or electrolyte instruments in addition to CO-oximeter instrument systems.

Method to prepare dye-based reference material

A family of solutions that can be used to calibrate one or more electrochemical sensors has been developed. These systems can be used to determine analytes in biological fluids, such as whole blood, serum, plasma and urine. Since these reagents require preservatives in order to make their shelf life and use life commercially feasible, a system of preservatives which exhibits unexpected synergy in antimicrobial capabilities has been identified. The preferred preservative system includes a mixture of 5-chloro-2-methyl-4-isothiazolin-3-one; 2-methyl-4-isothiazolin-3-one; and 1,3-bis-(hydroxymethyl)-5,5-dimethyl-2,4-imidazolidinedione.

Synergistic preservative systems for chemistry reagents

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West Roxbury, MA, United States of America

Liann Voo