Patent ID: 8119407

Claim:
A method for quality control of an instrument analyzer measuring total hemoglobin or hemoglobin fractions, and bilirubin, comprising: (i) introducing into said analyzer a quality control standard material comprising, a pre-determined clinically relevant concentration of hemoglobin sourced from red blood cells or a pre-determined clinically relevant concentration of hemoglobin-fraction sourced from red blood cells, and, one or more dyes having an absorbance spectrum similar to bilirubin concentrations at predetermined clinical levels, wherein said one or more dyes do not interfere with the absorbance of said predetermined concentration of hemoglobin or said pre-determined concentration of said hemoglobin fraction, wherein said quality control standard material is stable at 0-40° C. for at least 2 months storage; (ii) obtaining a spectral analysis by said analyzer of said control standard material to determine the absorbance of said hemoglobin or hemoglobin fractions and said one or more dyes; (iii) determining the concentration of said hemoglobin or hemoglobin fractions, and bilirubin in said quality control standard material from the spectral analysis in step (ii); and (iv) comparing said determination of said hemoglobin or hemoglobin fraction concentration, and said bilirubin concentration with said pre-determined concentrations of said hemoglobin or hemoglobin fractions, and bilirubin.