| Objective:In this study, by using chemiluminescence immunoassay(CLIA) and enzyme-linked immunosorbent assay(ELISA),this two kinds of methods to detect anti-cardiolipin(a CL) and anti-β2 glycoprotein I(anti-β2GPI) antibodies level in venous blood of missed abortion women and normal early pregnancy women, evaluating the value of laboratory diagnosis and clinical application of CLIA assay in missed abortion.Meanwhile, exploring the correlation and clinical significance between anti-cardiolipin(a CL) and anti-β2 glycoprotein I(anti-β2GPI) antibodies detected by CLIA assay and missed abortion.Methods:We choosed 14 women diagnosed missed abortion as trial group, gestational age < 12 weeks,while 20 normal females received induced abortion in the same time as control group,gestational age < 12 weeks,both groups selected from Department of gynaecology, Affiliated Hospital of Jiangsu University, August to December,2014. 2-3ml fasting venous blood was extracted from each case, quantitative detection serum Ig G/Ig M anticardiolipin antibodies and Ig G/Ig M anti-beta2 glycoprotein I antibodies level in two groups of patients respectively by using CLIA assay and ELISA assay.1.Comparing the consistency and correlation in the detection of anticardiolipin antibodies and anti-beta 2 glycoprotein I antibodies between CLIA assay and ELISA assay.2.Compared to ELISA assay, evaluating the diagnostic performance and clinical application value of CLIA assay in detection of anticardiolipin antibodies and anti-beta2 glycoprotein I antibodies.3.Analysing the level of serum Ig G/Ig M anticardiolipin antibodies and Ig G/Ig M antibeta2 glycoprotein I antibodies in the trial group and the control group by using CLIA assay,and comparing Whether there is difference between the trial group and the control group.4.All data using SPSS16.0 statistical software for analysis, P < 0.05 for the difference has statistical significance.Results:1.CLIA assay and ELISA assay in determination of serum anticardiolipin antibodies and anti-beta 2 glycoprotein I antibodies were positively correlated(P < 0.05), Spearman correlation coefficient r, distribution from 0.663 to 0.888, showed a strong positive correlation(P < 0.05).2.The area under the receiver operating characteristic curve of four antibodies Ig G antibeta2 GPI, Ig M anti-beta2 GPI, Ig G a CL, Ig M a CL by CLIA assay, were 0.804, 0.857, 0.827,0.820. The area under the receiver operating characteristic curve of the corresponding antibodies by ELISA assay respectively were 0.782, 0.848, 0.818, 0.804(P < 0.05); the area under the receiver operating characteristic curve of four antibodies which detected by CLIA were all slightly larger than that detected by ELISA.3.To using CLIA assay,the median levels of Serum Ig M a CL antibodies and Serum Ig M anti-β2GPI antibodies in trial group and control group showed statistically significant differences(Ig M a CL median levels:21.3(2.2~39.4)U/ml VS. 6.0(1.5~10.7)U/ml,Ig M anti-β2GPI median levels:11.9( 1.2 ~ 25.4) U/ml VS. 1.9( 1.1 ~ 4.0) U/ml; u =2.031 、 2.912; all P < 0.05). The levels of Serum Ig G a CL antibodies and Serum Ig G anti-β2GPI antibodies in trial group and control group, the difference had no statistical significance(Ig G a CL levels: 2.94±0.57 U/ml VS. 2.82±0.55 U/ml, Ig G anti-β2GPI levels:6.42±0.08 U/ml VS. 6.5±0.35 U/ml; t=0.621、0.986; all P>0.05).Conclusions:1.There is a high degree of consistency and correlation between CLIA assay and ELISA assay in the detection of anticardiolipin antibodies and anti-beta2 glycoprotein I antibodies.2.The diagnostic value of CLIA assay is better than ELISA assay, which has better clinical application value.3.Ig M anticardiolipin antibodies and Ig M anti-beta 2 glycoprotein I antibodies levels in missed abortion group was significantly higher than that in normal pregnancy group by CLIA assay,early and dynamic detection of anticardiolipin antibodies and anti-beta 2 glycoprotein I antibodies to reduce missed abortion incidence may have a certain clinical significance. |
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