Establish The Thromboelastography Reference Range Of Healthy People And Pregnant Women In Fujian Region

ObjectiveTo analyze the influence of pre-analysis factors on thromboelastography?TEG?detection,and the correlation of TEG parameters with conventional coagulation tests?CCT?and platelet parameters.To establish TEG reference range of healthy people and pregnant women in Fujian region.MethodsSamples from healthy volunteers and hospitalized patients were tested to analyze how did different testing time?from 5 min to 3 h?,different samples status such as hemolytic/fatty/diluent,different amount of specimen collection and personnel affect the results of TEG.The correlation between four main parameters of TEG?R,K,?and MA?and CCT indicators?PT,APTT,FIB and TT?and platelet correlation parameters?platelet count,MPV and PCT?was compared by testing samples from the same patient simultaneously.The sensitivity of TEG,CCT and PLT in the diagnosis of abnormal coagulation function was compared.The practicability of CCT standard in TEG inner-laboratory precision and inter-laboratory comparability verification was analyzed.Refered to Chinese health industry standard WS/T 202-2012,95%confidence interval of each parameter of TEG or the lower and upper limit of P_2.5^P_97.57.5 percentile from selected reference individuals was used toestablish a reference range of TEG parameters for healthy people and pregnant women in Fujian region.Results In addition to the K value of lipid samples,the results of TEG parameters of hemolysis and lipid samples were significantly different with normal samples?P<0.05?.With the extension of time,R?K and?showed a trend change,which showed that R decreased,K decreased and?increased,and the difference was significant in 5 min³0 min.MA increased at 15 and 30 min,soon decreased at 60min,which showed a"?"type fluctuation in 60 min.The results of R value after 30 min,MA after 1h,K and alpha after 2 h did not show significantly difference.There was significant difference in K value in the sample amount of 2.3 mL compared with sample amount of 2.0 mL,and no significant change in other parameters between 1.7 and 2.3 mL.The relationship between TEG and CCT showed that the R value was positively correlated with PT,APTT and TT,with the highest correlation of APTT?R=0.695?.?was positively correlated with FIB,PLT and PCT.MA was moderately positively correlated with FIB,PLT and PCT?r=0.676,0.647,0.675;P<0.01?,with the highest correlation of FIB.When PLT>280×10⁹/L,MA had no correlation with MPV.Meanwhile,when PLT<160×10⁹/L,MA had low correlation with MPV,and the correlation was slightly higher than with PLT?r=0.323 vs.0.299?.TEG had higher sensitivity with clinical diagnosis in hypercoagulation patient group than in hypocoagulation patient group,meanwhile it showed better compliance with clinical manifestation in both groups compared with CCT and PLT.The TEG parameters reference ranges of healthy people and pregnant women were established.The reference ranges of healthy people are R 3.7⁷.8 min,K0.9².9 min,?49.5⁷4.8°,MA 52.5⁷2.3 mm,and the reference ranges of pregnant women are R 2.7⁷.0 min,K 0.8¹.9 min,?62.8⁷9.1°,MA 54.1⁷9.4mm.There were significant differences in the parameters of pregnant women and non-pregnant women.The specificity of the manufacturer's reference range for healthy population in Fujian region was 83.0%.Conclusion TEG test should not use samples with hemolysis,lipid and dilution,and should be tested within 2⁴ h.The amount of sample collection within±15%of calibration line has no effect on the results.TEG is related to the number and function of CCT and PLT,and helpful to the correct clinicaldiagnosis of abnormal coagulation function.A reference range for the normal healthy people and pregnant women of the region should be established.