Quality Control Verification
For this study, a single lot of QC material for each level was used. The expected range (the range within which verifies proper system function) for each parameter and each level was programmed into the BioProfile FLEX and the BioProfile 100 Plus analyzers. All levels of QC material were equilibrated to room temperature prior to analysis.
Additional QC material provided for the measurement of particles for the BioProfile FLEX Cell Density/Viability module. This material contains polystyrene beads and was used to determine proper fluid flow, dilution, and calibration of the CDV modules and to confirm proper function of the imaging system on all FLEX analyzers used in this study.
For this study, it was important to use samples of known concentration, when available. For pH, gas, electrolyte, nutrient/metabolite, and osmolality measurements, Nova’s QC systems were used. These controls are manufactured to provide standards of known concentration across the analytical range.
Control levels 1, 2, and 3 provide for the measurement of pH, pCO2, pO2, glucose, lactate, NH4+, Na+, K+, Ca++, and osmolality. Levels 4 and 5 provide for the measurement of glucose, lactate, glutamine, and glutamate. To provide a greater sample set and additional points along the linear range of the analyzers, various standards were diluted with water for injection.
The expected values for the additional levels were determined mathematically by using the dilution ratio used to create the additional levels. It should be noted, however, that the additional levels created were not used for pH or gas measurements as these would have equilibrated with room air and would not provide acceptable measurements.
Cell culture samples obtained from a bioreactor were used for viable cell density, total cell density, and viability measurements.
Unless otherwise noted, all sample sets were analyzed in triplicate on each analyzer.
Calculations were used to determine the mean, standard deviation, and coefficient of variation for the data generated in this study.