Preliminary evaluation of spectrophotometry method for angiotensin converting enzyme
Fang Bing-xiong · Journal of Tropical Medicine · 2011
Objective To evaluate the angiotensin converting enzyme(ACE) test kit.Methods According to the CLSI document EP10-A2,Preliminary Evaluation of Quantitative Clinical Laboratory Methods;Approved Guideline-Second Edition,the low,middle and high control materials were tested with the specific sequence for five days.The dates were analyzed and the preliminary decision was made for the acceptability of the ACE test kit.Results The ACE values of the low,middle,and high control materials were 49,89.5 and 130 U/L,respectively.There were not outliers and the multiple regression equation of ACE was y=0.879x+8.45,r2 =0.9964.The absolute bias was 0.64,1.26 and-9.6 U/L,respectively,and imprecision(CV%)were 4.39%,2.26% and 1.39%,respectively.Conclusion Nonlinearity,imprecision and sample carry-over of the ACE test kit were accepted by EP10-A2.The high level bias should be studied in the future.