Clinical Study Of Electrochemical Immunosensor Based On Gold Nanomaterial For The Detection Of HCGβ Concentration In Spent Embryo Culture Medium

Objective:Establishing electrochemical immunosensor for hCGβ to analyze the correlation and diagnostic value of hCGβ concentration in spent embryo culture medium(SCM)with clinical pregnancy outcome.Methods:SCM of 49 infertile patients in the First Hospital of Shanxi Medical University treated by IVF-ET from December 1,2020 to December 31,2020 were collected and divided into2 groups according to clinical pregnancy outcomes,with 21 cases in pregnancy group and28 cases in non-pregnancy group.Electrochemical immunosensor based on gold nanoparticles was established to detect the concentration of hCGβ in SCM.Result:1.There was no significant difference in basic clinical data between pregnant group and non-pregnant group(P>0.05).The concentration of hCGβ in SCM in pregnant group(1.28±0.83 ng/m L)was higher than non-pregnant group(0.30±0.13 ng/m L)(P < 0.05).2.There were 28 cases with 0% implantation rate,15 cases with 50% implantation rate,and 6 cases with 100% implantation rate.The implantation rate increased with the concentration of hCGβ in SCM,and the differences among groups were statistically significant(P<0.05).3.The area under ROC curve of hCGβ level in SCM was 0.795(95%CI: 0.664～0.926),and the optimal cut-off value of hCGβ level in SCM for clinical pregnancy was 0.217ng/m L,corresponding to 90.5% sensitivity and 64.3% specificity.Conclusion:1.The sensitivity of hCGβ electrochemical immunosensor is high,which broadens the application limits of hCGβ.2.The concentration of hCGβ in SCM is correlated with clinical pregnancy outcome,which is expected to be a noninvasive indicator for predicting clinical pregnancy before embryo transfer.