Application of EP10-A2 for conducting methodological evaluation in pepsinogen Ⅰ detection by GICA / 国际检验医学杂志

ABSTRACT

Objective To use the colloidal gold immunochromatography (GICA ) method to conduct the methodological prelimi-nary evaluation on pepsinogen Ⅰ (PGI) reagent kit .Methods The method provide by the Preliminary Evaluation of Clinical Quan-titative Experimental Methods:Approval Guide Second Edition (EP10-A2) formulated according to the Clinical Laboratory Stand-ards Institute (CLSI) was used to continuously detect the low ,moderate and high concentrations of serum for 5 d ,Then the related data were collected for analyzing the dispersion degree ,linearity ,offset ,precision and so on .Results The PGⅠ quality control ser-um (concentration 25 ,50 ,100 μg/L) was detected at low ,medium and high concentration levels ,the linear regression equation ob-tained by analysis was Y=0 .9939X+0 .7433 ,correlation coefficient (R2 )=0 .9992 ;the offsets were 0 .37 ,0 .77 ,0 .78 μg/L re-spectively ,total imprecision was 3 .04% ,1 .17% and 1 .08% respectively .Conclusion The GICA related technical indicators of PGⅠreagent kit reach the standards of EP10-A2 document ,the detection results are accurate with high sensitivity and good stability , and conform to the requirements of clinical applications .