Methodological comparison on two kinds of method for detecting serum human epididymis protein 4 and bias evaluation / 国际检验医学杂志

ABSTRACT

Objective To compare the performance of 2 kinds of quantitative detection method the chemiluminescence immu-moassay and the enzyme-linked immunosorbent assay(ELISA)for detecting serum human epididymis geneproduct 4(HE4),and to explore the accuracy and practical value of the two methods.Methods In accordance to the document EP9-A2 of NCCLS,the Roche automatic electrochemical immunoassay system as the comparative method(X)and the ELISA as the testing method(Y )were per-formed according to the requirements of the detection kits.Results The serum HE4 level could be accurately reflected by the two methods.The correlation coefficient(r)in comparing these two kinds of method was ≥0.975,which showed that there was a high correlation between them.The detection results of the two methods were compared by paired sample t-test,and no statistically sig-nificant difference was found between them(P >0.05).Conclusion Because of CLIA′88 giving no specific medical decision level of HE4 and clinical acceptable level,therefore the expected bias of credibility interval can not be calculated or whether being clinically acceptable is unable to be judged.Based on the comparison of paired sample t test,these two kinds of detection methods can be used interchangeably to a certain extent.