Performance evaluation and results analysis of chemiluminescence method for detecting plasma BNP / 国际检验医学杂志

ABSTRACT

Objective To analyze and evaluate the precision ,accuracy and linearity of the chemiluminescence method for detec‐ting plasma BNP .Methods According to the experimental schemes of CLSI EP15‐A2 ,EP6‐A files and other relevant documents , the precision ,accuracy and linearity of the Siemens Centaur XP chemiluminescence instrument for detecting BNP ,and the detection results were compared with the performance declared by manufacturer or the quality target formulated by laboratory .Results The imprecision of BNP detected by the chemiluminescence method was less than 1/3 TEa regulated by the Clinical Laboratory Center of Ministry of Health (allowable total error);the variation coefficient index (CVR) of internal quality control data was less than ± 2;the relative bias of the results of external quality control blind samples with the target values were less than Tea regulated by the Ministry of Health ;the linear evaluation results showed that BNP was once linearity in the range of 5 .3‐4696 .7 pg/mL .Conclusion The precision ,accuracy and linearity of the Siemens Centaur XP chemiluminescence instrument for detecting BNP can accord withthe quality objectives requirements and meet the clinical needs .