Multi-Site, Multi-Country Evaluation of Analytical and Operational Performance of a Low-Mid Volume Chemiluminescent Immunoassay Analyzer

De Keijzer MH; Perkins S; Motta V; Morelli D; Cristol JP; Dupuy AM; Hong Y; Watanabe S; Waerdt C; Grunewald RW

Clinical Laboratory 55(9-10): 363-370

2009


ISSN/ISBN: 1433-6510
PMID: 20099573
Document Number: 13628
Background: A new automated immunoassay low-mid volume ( Methods: The laboratories followed standard protocols to assess precision, limit of detection (LoD), functional sensitivity, assay linearity, method comparison, and sample carryover. Turn around time for three stat assays (ß- hCG, BNP, and CK-MB) and the time required to complete workloads of 50 and 100 tests with a mixture of 75% routine tests and 25% stat tests was also evaluated. Results: Total precision was typically Conclusions: A multisite, international analyzer familiarization study is a practical means of confirming that a new instrument meets both a manufacturer's design specifications and users' real world expectations and provides a pragmatic test for the system. The experience of investigators at seven sites around the world indicates that a new fully automated chemiluminescent system is suitable for use.

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Multi-Site, Multi-Country Evaluation of Analytical and Operational Performance of a Low-Mid Volume Chemiluminescent Immunoassay Analyzer