METHODS: Precision was evaluated by running two levels of control material over multiple days. Linearity was evaluated using material provided by the manufacturer and the College of American Pathologists (CAP) linearity surveys. Accuracy was evaluated by comparing the results from 60 patient specimens on the Piccolo Xpress® with the Ortho Vitros® 5600 analyzer. The method comparison was performed on all three specimen types intended for use on the Piccolo Xpress®: serum, heparinized plasma, and whole blood. Manufacturer suggested reference ranges for all 14 analytes were tested in serum and plasma specimens from 23 healthy volunteers.
RESULTS: High precision (CV ≤ 10%) was noted for all the analytes. Linearity was found to span the clinically useful range for all analytes. The method comparison demonstrated minimal proportional bias and good correlation for most of the analytes in all three matrices tested. The only exceptions were for sodium and total CO2, for which either significant proportional bias and/or poor correlation was noted in all three matrices. Significant bias was noted for AST in serum as well as for total bilirubin in plasma and whole blood.
CONCLUSIONS: The Piccolo Xpress® allows for the delivery of CMP results in a footprint small enough to be stored in a biological safety cabinet, while providing satisfactory performance for the majority of analytes.