Performance Evaluation of a New Mobile POC Lipids Analyzer

Abstract

Hyperlipidemia, excessive amounts of fat and fatty substances in the blood, is a major risk factor for cardiovascular disease. The measuring of fat or fatty substance in blood is usually obtained through a blood lipid test which includes total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL) and high-density lipoprotein (HDL). In the Medical Device industry, Point-of-care (POC) methods provide fast, portable and easy to use devices suitable for rapid determination of Lipid levels. Here, we evaluated the analytical performance of PixoTest POCT Lipid System (iXensor Co., Ltd.), a newly developed POC lipid panel analyzer. PixoTest POCT Analyzer accuracy evaluation with the Cobas c111 Analyzer (Roche Diagnostics Ltd.) as a reference method was carried out according to CLSI EP 09-A3 guidelines. This study enrolled one hundred and twenty (120) subjects and conducted over three (3) clinical sites (40 subjects each), administered through nine (9) trained operators (total) performed under manufacturer’s protocol using three (3) reagent lots per blood sample (capillary & venous). Linear regression, bias plot and other statistical analyses were extrapolated from the test data in this study. Passing-Bablok regression analysis of the data between PixoTest POCT System and Roche Cobas c111 Analyzer with the venous blood showed a slope of 1.03, an intercept of − 0.1 and correlation coefficient of 0.99. The results for capillary blood showed a slope of 1.01, an intercept of − 0.04 and correlation coefficient of 0.99. Passing-Bablok regression analysis of the data (n = 120) from the comparison between the PixoTest POCT System and Roche Cobas c111 Analyzer with the TC venous blood of total 3 lots at 3 sites showed a slope of 0.99, an intercept of − 0.337 and correlation coefficient of 0.995 and the TC capillary blood showed a slope of 0.99, an intercept of − 0.105 and correlation coefficient of 0.984. TG venous blood of total 3 lots at 3 sites showed a slope of 0.99, an intercept of 0.0246 and correlation coefficient of 0.998 and TG capillary blood showed a slope of 0.99, an intercept of − 0.329 and correlation coefficient of 0.998. HDL venous blood showed a slope of 0.99, an intercept of − 0.0297 and correlation coefficient of 0.987 and the HDL capillary blood showed a slope of 0.99, an intercept of − 0.0403 and correlation coefficient of 0.989. The evaluation results of PixoTest POCT system’s accuracy, linearity, and correlation with Roche Cobas c111 Analyzer, the PixoTest POCT System displayed great performance results for all evaluated data points. Thus, the PixoTest POCT System is capable of providing accurate and reliable lipid measurements in the POC setting.