Primary study on stability and commutability of recombinant human muscle creatine kinase isozyme in different matrix / 临床检验杂志

ABSTRACT

Objective To investigate the stability and comparability of recombinant human muscle creatine kinase isozyme(CK-MM)in different matrix,and to find out a suitable matrix as a reference material for application of CK measurement system.Methods The stability of the recombinant CK-MM was observed by measuring its catalytic activity in self-made matrix,anti-freeze additive matrix,the certified reference material(CRM)matrix and human serum matrix respectively.For understanding the commutability among different measurement system total CK catalytic activity in various concentration of human serum and the catalytic activity of recombinant CK-MM in different matrix specimen were measured with IFCC recommended reference method and routine reagent produced by Roche and Zhongsheng Diagnostic Company respectively.Results The recombinant CK-MM was stable for 25 days in the self-made matrix,23 days in CRM matrix and at least 240 days in antifreeze additive matrix stored at-20 ℃.The recombinant enzyme protein in self-made matrix and CRM matrix was commutable.Low concentrations of recombinant CK-MM in human serum and in anti-freeze additive matrix were also commutable.Conclusion The recombinant CK-MM had good stability and commutability in either self-made matrix or CRM matrix.It might be used as a candidate reference material for the determination of total creatine kinase in serum.