Delta特定蛋白分析仪检测C-反应蛋白的性能验证

Performance verification of analyzing C-reactive protein by Delta specific protein analyzer

目的对Delta特定蛋白分析仪检测C-反应蛋白(CRP)的性能进行验证。方法参考美国临床和实验室标准协会(CLSI)和参考区间行业标准(WS/T)文件对Delta特定蛋白分析仪的精密度、携带污染率、准确度、功能灵敏度、临床报告范围、抗干扰能力、参考区间进行验证。结果低、高两个浓度水平样本的批内变异系数(CV)分别为2.43%和2.57%,实验室内总CV分别为3.24%和3.41%,精密度验证均通过厂家声明;携带污染率为0.65%,满足临床要求。两个不同批号仪器校准品的准确度验证相对偏差分别为6.09%和4.87%,参考物质的靶值在95%置信区间内。当功能灵敏度为1.375 mg/L;临床可报告范围为1.375~12 457 mg/L,满足临床需要。干扰试验显示含246.7μmol/L总胆红素的黄疸标本、含4.15 mmol/L三酰甘油的血脂标本和含2.50 g/L血红蛋白的溶血标本对CRP检测的影响度均<5%,在可接受范围内;参考区间的验证结果均在厂家提供的范围内。结论 Delta特定蛋白分析仪采用散射免疫比浊法测定CRP的分析性能符合厂商声明的标准,满足临床检测的要求。

Objective To test and verify the performance of C-reaction protein（CRP） detected by Delta special protein analyzer.Methods The precision,carryover rate,accuracy,functional sensitivity,clinical reportable range,interference analysis and reference interval were verified according to American Clinical and Laboratory Standards Institute（CLSI） and Chinese Healthcare Industry（WS/T） standards.Results The withinrun precision variable coefficient（CV） of low and high concentrations was 2.43% and 2.57% respectively,while the overall precision CV was 3.24% and 3.41% respectively.Precision has been demonstrated to be consistent with the manufacturer＇s claim.The carryover rate was 0.65%.It can satisfy clinical requirements.The relative bias of accuracy in two different batches was 6.09% and 4.87% respectively,the target values of reference materials were both within the 95% confidence interval.The functional sensitivity was 1.375 mg/L.The clinical reportable range from 1.375 to 12 457 mg/L,can meet the clinical needs.Interference analysis showed the effect of 246.7 μmol/L concentration of total bilirubin,4.15 mmol/L concentration of triglyceride and 2.50 g/L concentration of hemoglobin on CRP detection was within acceptable range.The verification results of the reference interval were within the scope provided by the manufacturer.Conclusion The major performances of CRP detected by Delta special protein analyzer using nephelometry immunoassay,was in line with the manufacturer＇s statement.It can meet the clinical testing requirements.