Evaluation of the i-Smart 30 Point-of-Care Analyzer for Use in Clinical Laboratory Settings

Abstract

BACKGROUND: The i-Smart 30 point-of-care (POC) analyzer (i-SENS, Korea) is a compact and portable system used for the analysis of electrolytes (sodium, potassium, chloride) and hematocrit in whole blood samples. In this study, we evaluated the analytical performance of the i-Smart 30 analyzer. METHODS: Precision and sample-related percent carry-over were determined using the quality control materials. Comparison study was performed with the Stat Profile Critical Care Xpress (STP CCX; Nova Biomedical, USA) analyzer using venous whole blood samples. RESULTS: In the precision study, imprecision studies demonstrated within-run and total-run coefficients of variation within 0.5-3.9% and 0.7-4.4%, respectively, for all analytes. A good correlation was found between the i-Smart 30 analyzer and the STP CCX analyzer, except for chloride that showed high intercept. In the study of carry-over, sample-related carry-over for Na+, K+, Cl- and Hct were demonstrated as 0.84%, 0%, 0.86% and 1.56%, respectively. CONCLUSIONS: We conclude that the i-Smart 30 analyzer is suitable for routine use in clinical laboratories, especially where rapid test results are required such as emergency departments, intensive care units, and dialysis units. However, for Cl-, it is necessary that a significant correlation between this analyzer and a reference method should be demonstrated.