BECKMAN DxI 800全自动化学发光仪甲状腺检测项目的性能验证

Analytical performance verification of BECKMAN DxI 800 automated chemiluminescence analyzer in de- tecting thyroid

目的评价BECKMAN DxI 800全自动化学发光仪甲状腺检测项目(TT3、TT4、FT3、FT4、TSH)的分析性能。方法参照美国临床实验室标准化协会(CLSI)文件,对BECKMAN DxI 800全自动化学发光仪检测TT3、TT4、FT3、FT4、TSH的精密度、线性范围及生物参考区间等方面进行验证,并与厂商声明的性能标准进行比较。结果批内和批间精密度即变异系数(CV)均小于厂家声明的CV值,均在允许范围内;线性范围验证结果显示,各检测项目的斜率(a值)均在(1±0.05)范围内,相关系数(r值)≥0.975,均在仪器要求范围内,并具有良好的线性;生物参考区间与厂商提供的性能指标相符。结论 BECKMAN DxI 800全自动化学发光仪5项甲状腺检测在精密度、线性范围及生物参考区间三个性能指标上,均在相关要求范围内,符合实验室要求,可应用于临床检测。

Objective To detect the thyroid （TT3,TT4,FT3,FT4,TSH） analytical performance verification by BECKMAN DxI 800 automated chemil analyzer. Methods According to the American Society for Clinical Laboratory Standards （CLSI） documents,the precision, linearity and biological reference interval of the BECKMAN DxI 800 automated chemiluminescence analyzer system in detecting TT3, Tr4, FT3, FT4, TSH were detected. Results The CV values of intra-and inter-precision were less than manufaeturer＇s declaration, and within the allowable range; the validation results of linear range showed that,the value of a test items were （ 1 ± 0.05 ） within the range, the value of the correlation coefficient r ≥ 0. 975, are within the requirements of the instrument, and has good linearity. Biological reference intervals are consisted with Vendor performance metrics. Conclusion The BECKMAN DxI 800 automated chemiluminescence analyzer system in detecting five thyroid hormone in precision, linear range and biological reference intervals three performance indicators, are within the requirements of the instrument, to meet the laboratory requirements, can be used in clinical testing.