ABSTRACT
Objective To study the influence factors on detection coagulation factors Ⅸ activity in human prothrombin complex concentrates(PCC).MethodsUsing Chinese Pharmacopoeia(2010)as reference,factor Ⅸ deficient plasma from different manufacturers,different types of instruments,different methods of heparin neutralization,different sample pretreatment methods were used to determine the activity of coagulation factor Ⅸ in PCC.The influence on the results of coagulation factor Ⅸ was analyzed.ResultsThere was a significant difference between factor Ⅸ deficient plasma from different manufacturers for the activity of coagulation factors Ⅸ(P<0.05).There was no significant difference between the results of coagulation factor Ⅸ measured by different types of Automatic Coagulation Analyzer.When the dilution ratio was more than 60 times,the neutralization of heparin had little effect on the coagulation factor Ⅸ activity.When the dilution ratio is less than 60 times,the detection results of coagulation factor Ⅸ by neutralization of heparin are higher than no neutralization of heparin,and the difference is significant(P<0.05).Samples for pre-temperature or not and whether dissolution for 15minutes or not,the coagulation factor Ⅸ activity showed no significant difference.Conclusion The coagulation factor Ⅸ activity in PCC was affected by factor Ⅸ deficient plasma from different manufacturers,different dilution times of heparin neutralization method and sample pre-treatment methods.It must be paid attention to in the detection process.Strengthen the quality control of the factor deficient plasma and the standardization of operation process are necessary.The External Quality Assessment for the detection of coagulation factors in PCC products should be edtablished.