两种检测方法在HbsAg低浓度标本检测结果的分析

摘要

目的：对于化学发光磁微粒子免疫分析法（CMIA）和酶联免疫吸附法（ELISA）在乙肝表面抗原检测中低浓度标本结果对比分析。方法先用时间分辨免疫荧光法（TRFIA）检测并确定HbsAg低浓度标本（0.5~1.0 ng/mL）236份和HbsAg阴性标本（约0.5 ng/mL）100份。分别使用CMIA和ELISA进行检测，对检测结果进行对比分析。结果ELISA法检测出阳性标本为195例，阳性率为82.6%。CMIA法检测出阳性标本为232例，阳性率为98.3%。差异有统计学意义（χ2=33.62，P<0.05)。ELISA法敏感度为84.1%，CMIA法敏感度为98.7%。差异具有统计学意义（χ2=30.21，P<0.05）ELISA法特异性为95%，CMIA特异性为97%。其差异无统计学意义（χ2=0.8353，P>0.05）。结论CMIA法敏感度和特异性均高于ELISA法，建议在HbsAg的检测尤其是低浓度标本的检测中使用高敏感度与高特异性的方法。%Objective To compare and analysis the results for chemiluminescent magnetic micro particle immunoassay (CMIA) and enzyme-linked immunosorbent assay (ELISA) in low concentration samples of hepatitis B surface antigen detection. Methods Hb-sAg low concentration (0.5~1.0 ng/mL) 236 and HbsAg negative samples (0.5 ng/mL) 100 were detected by time resolved im munofluorescence assay (TRFIA). CMIA and ELISA were used to detect and compare the results. Results 195 positive samples were detected by ELISA, the positive rate was 82.6%. 232 cases positive samples were detected by CMIA method, the positive rate was 98.3%. The two groups was statistically significant (χ²=33.62,P<0.05). The sensitivity of ELISA was 84.1%, and the sensitivity of CMIA was 98.7%, the difference was statistically significant (χ²=30.21, P<0.05) ELISA, the specificity was 95%, the specificity of CMIA was 97%. The difference was not statistically significant (χ²=0.8353, P>0.05). Conclusion The sensitivity and specificity of MIA were higher than ELISA, and it was suggested that the method of high sensitivity and specificity in the detection of HbsAg was used, especially in low concentration samples.