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 .
ABSTRACT
Objective To evaluate the performance portable analyzer and reagent disc kit for liver function tests .Methods Ac‐cording to EP10‐A2 document of Clinic and Laboratory Standards Institute ,specimens with high ,medium and low concentrations were measured continuously in a specific order for 5 days .The bias and the total imprecision were calculated ,and the intercept ,slope rate ,non linearity ,carryover contamination and drift were analyzed by using multiple regression analysis .Results The bias and pre‐cision of specimens with high ,medium and low concentrations were all within acceptable ranges .No significant difference was showed in intercept ,slope rate ,non linearity ,carryover contamination and drift(P>0 .05) .Conclusion Portable analyzer and rea‐gent disc kit for liver function tests could be with fine precision ,fine linearity ,low carryover contamination and good stability ,and could meet clinical application requirement .