Evaluation of the i-STAT Alinity Point-of-Care Analyzer

Abstract

Objectives The objective of this study was to evaluate the analytical performance of CG4+ and CHEM8+ cartridges on the i-STAT Alinity analyzer prior to use in patient testing. We also evaluated the ease of use, design, and safety features to determine its suitability for use by the clinicians in our hospital. Methods The Abbott i-STAT System Performance Verification Protocol was observed for the imprecision study and was performed over the course of 2 days using 2 levels of control material (Abbott i-STAT TriControl Level 1 and Level 3). The CLSI-EP6-A guideline was used to verify the assay reportable range performance using 5 levels of linearity material (Abbott i-Stat TriControl Calibration Verification Set). The method comparison study was performed using up to 60 leftover anonymized heparinized whole-blood samples and serum samples against existing laboratory instruments (Siemens Rapidpoint 500, Abbott Architect C16000, and Sysmex XN9000). Results Precision was good (coefficient of variation <2%) for electrolytes, glucose, lactate, and pH, and satisfactory (coefficient of variation <5.2%) for blood gases, urea, creatinine, and hematocrit. Linearity concentrations spanning the analytical measuring ranges were demonstrated for all analytes. Method comparison studies revealed that agreement between the i-STAT Alinity analyzer and the central laboratory analyzers was good and clinically acceptable. Conclusions The i-STAT Alinity analyzer has good analytical performance, and we established the analyzer meets our safety and regulatory requirements and therefore suitable for use in our hospital as a point-of-care testing device.