Abstract:

Objective To evaluate the performance of 3 kinds of commercial serum cholinesterase（CHE） determination kits by manual method recommended by German Clinical Chemical Association（Deutsche Gesellschaft für Klimische Chemie,DGKC）. Methods Through manual DGKC method,the performance of the 3 kinds of serum CHE determination kits,including the correlation with manual DGKC method,comparability,imprecision and linear range,was evaluated. Results There was a good correlation of the 3 determination kits with manual DGKC method（r²=0.999）,and the relative deviation between the upper and lower limits of CHE reference intervals of the 3 determination kits and manual DGKC method was <1/2 allowable total error （TEa）（7.5%）. The repeatabilities were all <1%,and within-laboratory precisions were all ≤1.5%. Using relative bias <7.5% as standard,the linear ranges of manual DGKC method and the 3 determination kits were 417-26 363,1 605-17 609,788-30 853 and 839-25 767 U/L,respectively. The lower limit of the 3 determination kits were higher than that of manual DGKC method. The upper limit of linear range had exceeded the upper limit of linear range declared by the manufacturer. Conclusions The 3 kinds of serum CHE determination kits have good determination performance without matrix effect,which may meet the needs of clinical determination.

Key words: Cholinesterase, German Clinical Chemical Association, Manual method, Performance evaluation