Multiple site analytical evaluation of a portable blood gas/electrolyte analyzer for point of care testing.

Abstract

To evaluate the analytical performance of the SenDx 100 portable blood gas and electrolyte analyzer (SenDx Medical, Carlsbad, CA). Accuracy was evaluated by correlation of whole blood patient samples with the Nova Stat Profile 5 (Nova Biomedical, Waltham, MA) and the Ciba Corning 865 (Chiron Diagnostics, Medford, MA). Precision was evaluated using quality control materials (RNA Medical, Acton, MA). Critical care laboratories and operating rooms in two institutions. Precision studies performed at three different concentration levels for each analyte demonstrated intra-assay precision of < or =2.5% coefficient of variation and interassay precision of < or =4.0% coefficient of variation in all cases. Analysis of patient specimens in general showed good to excellent correlation to reference analyzers. Regression variables are tabulated. The SenDx 100 portable blood gas and electrolyte analyzer is a simple and easy to use analyzer demonstrating acceptable performance compared with reference methods.