BECKMAN DxI 800全自动化学发光仪检测泌乳素的性能验证

目的 对BECKMAN DxI 800全自动化学发光仪检测泌乳素(PRL)的分析性能进行验证。方法 参照美国临床实验室标准化协会(NCCLS)的文件,选取病人血清和质控室间质评质控品,对PRL的批内精密度、批间精密度、准确度、线性范围等方面进行验证。结果 PRL的批内和批间精密度CV值均小于厂家声明的CV值,在允许范围内; PRL线性范围验证结果显示,a值为1.011 4,r值为0.997 4,均在仪器要求范围内,并具有良好的线性; PRL准确度验证结果显示,测定5份室间质评的检测结果与“靶值”的偏倚为-1.18%～-7.78%,均在室间质评的测量范围之内。结论 BECKMAN DxI 800全自动化学发光仪测定PRL在精密度、准确度、线性范围等性能指标均在仪器要求范围内,符合要求,可应用于临床检测。

Analytical Performance Verification of BECKMAN DxI 800 Automated Chemiluminescence Analyzer in Detecting PRL

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)documents,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 inter-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 excellentlinearity; 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.