Analytical evaluation of cardiac poct: humasis hubi-quanpro troponin I

Abstract

Point-of-care testing (POCT) of cardiac troponin device is aimed for improvement in turn round time (TAT) and assist in acute management care of acute coronary syndrome (ACS). The present study was conducted to assess the analytical performance and correlation of HUBI-QUANPro troponin I with an existing laboratory instrument of high-sensitivity troponin I, Abbott Architect. The factors that were studied, included precision study by using manufacturer quality control (QC) material (2 levels) and correlation study of sample differences (whole blood, plasma and serum) and methodology (immunochromatographic assay and chemiluminescent immunoassay). A total of 30 QC was used for precision study and 42 sample serum and EDTA for the correlation study. An acceptable total imprecision of 10.9% and 6.7% were seen at level of 0.91 ng/mL and 2.66 ng/mL, respectively. Regression analysis of sample differences (plasma vs whole blood) in HUBI-QUANPro showed slope of 0.935, r=0.991 (p=<0.001). Correlation of HUBI-QUANPro and Abbott Architect (whole blood, plasma vs serum) both demonstrated regression slope of 0.205, r=0.963 (whole blood) and slope of 0.192, r=0.954 (plasma), p=<0.001, respectively. HUBI-QUANPro troponin I POCT device is a sensitive, fast, precise and has a good comparable analytical performance with reference laboratory instrument for cardiac troponin I measurement. It is able to serve as a good POCT device in cardiac-related acute care management.