The comparability on the results of a self-developed biochemical testing system and standard testing system

Objective To investigate a method to achieve the comparability on the results of a self-developed biochemical testing system and a standard testing system.Methods The standard testing system was composed of Hitachi 7600 automatic biochemical analyzer,Roche reagent,Roche cfas calibrator and Roche quality control.The quantity was transmitted into the fresh mixed patients′ sera.The indicative value of the cfas calibrator was transferred into the actual value on the ARCHITECT C8000/Shanghai Kehua system,which was then regarded as the calibrator to evaluate self-developed testing system.Following National Committee for Clinical Laboratory Standards(NCCLS) document EP-9A,a comparative study between 2 testing systems was performed by detecting 7 serum enzyme items [alanine aminotransferase(ALT),aspartate aminotransferase(AST),alkaline phosphatase(ALP),gamma-glutamyltransferase(GGT),creatine kinase(CK),lactate dehydrogenase(LDH) and amylase(AMY)].The results were analyzed,and the bias was evaluated.The allowable error within the 1/4 standard of Clinical and Laboratory Standards Institute(CLIA)′88 was acceptable.Results Before quantity transmitting,the correlation coefficient(r) was ≥0.975 between 2 testing systems.The system error(SE%) of ALT and GGT was1/4 CLIA′88 and was not acceptable.After quantity transmitting,the results were analyzed by regression,and the values of r,linear equation slope rate(a) and intercept(b) were improved.The SE% was ≤1/4 CLIA′88,which could be accepted.Conclusions After quantity transmitting,using fresh mixed serum can calibrate a self-developed testing system.The traceability and comparability can be improved between self-developed testing system and standard testing system.