Clinical Evaluation Of Thromboelastography And Its Associated Reagents

Objective:To assess the correlation and consistency of self-made thromboe-lastography(TEG)with its associated test kit and Haemonetics Corporation’s TEG with its test kit in detecting blood coagulation function of patients,the coagulation results were comparatively analyzed.Methods:The self-made thromboelastography and its associated reagents were used to detect blood coagulation function of the patient,and compared with TEG~?5000 thromboelastography that produced by Haemonetics Corporation.A total of 178 patients were selected randomly from July to December 2018 in the China-Japan Union Hospital of Jilin University.Two kinds of TEGs and reagents were used to detect coagulation state by parallel and cross testing.Our experiment was divided into three groups,and a total 2ml venous blood with sodium citrate were performed by parallel-cross testing of two kinds of TEGs and reagents respectively from the same patient as follows:the first group used the self-made TEG and its reagent(R1,K1,α1,MA1);the second group used the TEG~?5000and its reagent(R2,K2,α2 MA2);the third group used the TEG~?5000and the self-made reagent(R3,K3,α3,MA3).The four main outcome parameters R,K,α,and MA after kaolin activated the blood sample were selected,compared and analyzed.The consistency of test results was analyzed by pearson correlation,intra-class correlation coefficient(ICC)and Bland-Altman method using SPSS 17.0 statistical software.Results:The analysis results of self-made TEG with its associated reagents and TEG~?5000 with its reagent in clinical consistency are as follows,Pearson correlation analysis:the correlation coefficients of R1 vs.R2,R2vs.R3,R1 vs.R3 are 0.875,0.837,0.896,respectively;the correlation coefficients of K1 vs.K2,K2 vs.K3,K1 vs.K3 are 0.743,0.761,0.813,respectively;the correlation coefficients ofα1 vs.α2,α2 vs.α3,α1 vs.α3were 0.715,0.712,0.735,respectively;the correlation coefficients of MA1 vs.MA2,MA2 vs.MA3,MA1 vs.MA3 were 0.840,0.856 0.831,respectively(p<0.001).Intra-class correlation coefficient(ICC)analysis:the ICC results for the R,K,αand MA values for the three groups test were 0.866,0.718,0.688,and 0.792,respectively(p<0.001).Bland-Altman analysis showed that data outside of 95%LOA was within10%in four groups.Conclusions:1、The correlation and consistency of self-made TEG and Haemonetics Corporation’s TEG~?5000 TEG with their reagents respectively in blood coagulation function tests of patients are extremely well.2、The self-made TEG and its reagent may replace imported TEG and its reagent for the detection of coagulation function in patients.3、The self-made reagent can also be applied to imported TEG and make the imported TEG reagents localization.