ESTABLISHMENT OF THE JAPANESE STANDARD FOR HUMAN COAGULATION FACTOR IX

Abstract

The first Japanese standard for human coagulation factor IX was established in 1995 using the 2^nd International standard as a reference. In 2004, the 2^nd Japanese standard for human coagulation factor IX was developed. This report describes a collaborative study among five laboratories conducted to assign the potency of the 2^nd Japanese standard. The data shown here are the results obtained with the one-stage assay followed by parallel line analysis using the 3^rd international standard as a reference. In conclusion, the 2^nd Japanese standard was established with a potency of 75.0IU/ml.