Analytical Performance Verification of BECKMAN DxI 800 Automated Chemiluminescence Analyzer in Detecting PRL
10.3969/j.issn.1671-7414.2015.01.037
- VernacularTitle:BECKMAN DxI 800全自动化学发光仪检测泌乳素的性能验证
- Author:
Fangfang CHEN
;
Jialiang LI
;
Zhongshu ZHANG
;
Guohong WANG
- Publication Type:Journal Article
- Keywords:
prolactin;
performance verification;
precision;
accuracy;
linear range
- From:
Journal of Modern Laboratory Medicine
2015;(1):126-127,131
- CountryChina
- Language:Chinese
-
Abstract:
Objective To detect the prolactin (PRL)analytical performance verification by BECKMAN DxI 800 automated chemiluminescence analyzer.Methods According to the American Society for Clinical Laboratory Standards (NCCLS)doc-uments,selected the patient’s serum and EQA control materials,the precision,accuracy and linearity of the BECKMAN DxI 800 automated chemiluminescence analyzer system in detecting PRL were detected.Results The CV values of intra-and in-ter-precision were less than manufacturer’s declaration,and within the allowable range.The validation results of linear range showed that,a value of 1.0114,r value of 0.9974,both within the requirements of the instrument,and has excellent lineari-ty;the relative bias between the measured results and the EQA control samples at five levels was -1.18%~-7.78%,both within the scope of the EQA measurement.Conclusion The BECKMAN DxI 800 automated chemiluminescence analyzer system in detecting PRL in precision,accuracy,linearity and other performance indicators were within the requirements of the instrument,tomeet the requirements,can be used in clinical testing.
