Analytical evaluation of HgbA1c, microalbumin, CRP, and RF on Architect ci8200 integrated system and workflow performance evaluation using computer simulation

Background: Recently, hemoglobin A1c (HgbA1c), microalbumin (MA), C-reactive protein (CRP) and rheumatoid factor (RF) have been introduced on high throughput general chemistry system. We evaluated analytical performance of these assays on an integrated clinical chemistry and immunoassay analyzer and studied the impact of testing these assays on these systems on the overall efficiency of the analyzer, via computer simulation. Methods: The analytical performance was measured by determining precision, linearity and correlation of patient sample results with in-house testing methodology. MedModel simulation software is used to develop simulation model and process efficiency is determined by measuring turnaround times and resource utilization. Results: Between-days CVs ranged from 8.59% for MA to 3.22% for HgbA1c level 1 controls. Less than 2% carryover for all 4 methods was observed on the integrated analyzer. For HgbA1c on HPLC analyzer, the minimum and maximum TAT for a batch of 50 samples was 3.78 and 160 min, respectively, while for the integrated system it was 28.2 and 35.1 min, respectively. Labor utilization for the 2 processes ranged from 3.21% to 3.75%. Conclusion: Chemistry module on an integrated system can be used to determine the HgbA1c and other serum proteins.