Establishment and performance evaluation of a domestic chemiluminescence immunoassay of serum HE4 / 中华检验医学杂志

ABSTRACT

Objective@#To establish and evaluate a domestic Chemiluminescence immunoassay(CLIA) for detecting serum human epididymis protein4(HE4).@*Methods@#To establish a double antibody sandwich CLIA for the determination of serum HE4. Fluorescein isothiocyanate (FITC) and alkaline phosphatase (ALP) were used to label two different monoclonal antibodies of HE4. The separation could be realized by the magnetic particles coated with anti-FITC antibodies. Measure the relative light unit (RLU) after adding substrate solution, the RLU is proportional to the concentration of HE4. After evaluating the analytical performance including sensitivity, precision, accuracy, linearity, specificity under the optimized condition, this study compared the method with the commerical HE4 kits as well.@*Results@#The precision of with-in lot , and with-out lot are less than 4.0% and 5.0% respectively; Recovery is within 90.0%-110.0%; LoB is 5.0 pmol/L; functional sensitivity is 15.0 pmol/L; measure range is 15.0-1 500.0 pmol/L; the Correlation coefficient is bigger than 0.99 comparing with commercial kits. The AUC(area under curve) of three methods is 0.895, 0.900 and 0.896 respectively.@*Conclusions@#This study established a sensitive CLIA method with high repeatability and wide measure range; it has good correlation with commercial HE4 test kits.(Chin J Lab Med, 2018, 41: 615-620)