A Multicenter Assessment of the Analytical Performance of the Routine Thyroid Panel on the Olympus AU3000i TM Immunoassay System
Bertsch, T.; Aschenneller, C.; Herzog, V.; Dupuy, A.M.; Bargnoux, A.S.; Stéphanie Badiou; Ebel, A.; Winter, A.; Graf, A.; Rauch, S.; Jürgen Durner; Holdenrieder, S.; Fraunberger, P.; Gamble, R.; Sheridan, B.; Kukula, J.; Kenny, P.; Cristol, J.P.
Clinical Laboratory 55(11-12): 447-458
2009
ISSN/ISBN: 1433-6510 PMID: 20225667 Document Number: 10539
Background: The AU3000i™ thyroid assay panel (TSH, fT4, T4, fT3, T3) was evaluated at four sites in a European multicenter study. The study was designed to assess the basic analytical performance characteristics of the Olympus thyroid assays. In addition, a comprehensive assessment of the TSH functional sensitivity was undertaken to challenge the manufacturer's claim of 4th generation assay performance. Results: Repeatability (within-run precision) of TSH, fT4 and T4 was better than 3% across the measurable range, T3 and fT3 repeatability was better than 6%. Within-laboratory (total) precision was better than 10% for all assays, for fT4, it was better than 3%. Method comparisons were undertaken against the Roche Elecsys® 2010, the Siemens Advia Centaur® and the Abbott Architect®. Overall, good to excellent correlations were seen, however in some cases there were systematic differences which can be attributed to the lack of an appropriate standard or reference method and/or heterogeneity of the analyte. The functional sensitivity of the Olympus TSH assay was confirmed to be 4th generation, giving a mean functional sensitivity (at 20% CV) of 0.0011 mIU/L with no sites exceeding 0.002 mIU/L. Plasma (Li-heparinate) was shown to be an acceptable sample type for use in these assays. Conclusion: The results generated in this study indicate that the assays of the Olympus AU3000i™ routine thyroid panel are precise, correlate well with other established assays, and are suitable for use in the routine clinical laboratory.
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