Abstract:

Objective To use prokaryotic cell to express human carcinoembryonic antigen（CEA）,and use it in the development of quality control materials. Methods Gene engineering methods were used to construct prokaryotic expression vector pCold1-cea,and the vector was transferred into Escherichia coli BL21（DE3） to express recombinant human carcinoembryonic antigen（rhCEA）. Results The inclusion bodies of rhCEA were formed in Escherichia coli BL21（DE3） after purification and refolding,which was used into the preparation of quality control materials. The results of quality control materials on Abbott platform were 235.35 ng/mL for high level,68.04 ng/mL for middle level and 11.97 ng/mL for low level. The results on Roche platform were 32.27 ng/mL,7.99 ng/mL and 1.35 ng/mL for high,middle and low levels,respectively. The results on Wondfo platform were 5 ng/mL for high level,and the results for middle and low levels had not been determined. Conclusions Quality control materials prepared by rhCEA have been analyzed in different analysis systems with obvious determination results. The quality control materials are more suitable for Abbott platform than the other 2 platforms.

Key words: Prokaryotic expression, Carcinoembryonic antigen, Inclusion bodies, Quality control materials