Analytical performance of the electrochemiluminescence immunoassay system in detecting beta subunit human chorionic gonadotropin / 中华检验医学杂志

ABSTRACT

Objective To validate analytical performance of electrochemiluminescent immunoassay ?-HCG and explore a suitable validation mode on electrochemiluminescent immunoassay system of Elecsys 2010 under the guidance of evidence-based laboratory medicine.Methods The analytical performance of the electrochemiluminescence immunoassay(ECLIA)system of Elecsys 2010 including precision,analytical sensitivity,linear range,accuracy and reference range was validated by detecting the specimens of different concentrations.The results were analysed by statistical package for social science 10.0.Results Imprecision studies yielded with-run CV of 0.43%-2.12% and between-day CV of 1.07%-3.73%;CV for total imprecision were 1.81%-4.90%.Recovery after dilution of high-concentration samples in assay diluent were within the rang of 94%-110%.Analytical sensitivity was