Performance evaluation of portable analyzer and reagent disc kit for liver function tests
10.3969/j.issn.1673-4130.2015.21.008
- VernacularTitle:便携式生化分析仪及配套干式微管生物芯片肝功能试剂盘性能评价
- Author:
Jihua ZOU
;
Xiaozhong CAI
- Publication Type:Journal Article
- Keywords:
portable analyzer;
reagent disc kit for liver function tests;
EP10-A2;
performance evaluation
- From:
International Journal of Laboratory Medicine
2015;(21):3095-3097
- CountryChina
- Language:Chinese
-
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 .
