Fit-for-purpose evaluation of architect i1000SR immunoassay analyzer

Background: Last year Abbott Laboratories introduced the Architect i1000. SR modular chemiluminescent immunoassay analyzer for laboratories performing <200. test/day. The analyzer has a diverse menu of most routinely tested assays for the low to mid volume hospital laboratory. We evaluated the analytical performance, productivity and efficiency of this system for a 1-y period. Method: The analytical performance was ascertained by i) determining functional sensitivity in serum matrix for cTnI and measuring precision for other assays. ii) Accuracy was determined by performing patient correlations for TSH, cTnI and FT4 assays. iii) Analyzer productivity and efficiency were evaluated by determining the expected annual throughput and impact of routine workload on STAT TATs, respectively. Results: Coefficient of variation ranging from 3.6 to 8.2% was achieved for all assays evaluated. Functional sensitivity for cTnI was found to be 0.05. ng/ml. Patient correlation gave regression coefficients ranging from 0.875-0.998. An average hourly throughput ranged from 41-48 tests per hour (tph). Conclusions: We find the Architect i1000. SR random access immunoassay analyzer met all of the requirements desired in a low to mid volume instrument. Stat turn around times (TAT) are maintained to <. 20. min.