AFIAS-50全自动荧光免疫分析仪测定超敏C反应蛋白的性能

Performance of AFIAS-50 automatic fluorescent immunoassay analyzer in measurement of hypersensitive C-reactive protein

目的 对AFIAS-50全自动荧光免疫分析仪(简称AFLAS-50)检测超敏C反应蛋白(hs-CRP的性能进行分析和评价。方法 参考美国临床和实验室标准化协会(CLSI)标准,对AFIAS-50检测hs-CRP的检出限、精密度、准确度、线性、参考范围、抗干扰等主要性能进行分析和评价。结果 批内精密度和批间精密度[变异系数(CV%)]分别为2.28%~5.50%和1.13%~5.10%,均在要求范围内;检出限为0.5 mg/L,符合临床检测要求;准确度实验表明AFIAS-50与BNⅡ特定蛋白分析仪检测结果有较好的相关性(r=0.997 3,P<0.05);参考范围验证显示,20名健康人结果均<8 mg/L,符合要求,可以引用厂商推荐的0~8.00 mg/L;三酰甘油(TG)和总胆红素(TBIL)对检测结果的影响度均<10%,在可接受的范围内,抗干扰能力符合要求。结论AFIAS-50全自动荧光免疫分析仪检测hs-CRP的各项性能指标良好,对临床诊断具有一定的应用价值。

Objective To investigate and evaluate the performance of the AFIAS-50 full-automated fuorescence immunoassay analyzer(AFIAS-50)in measurement of hypersensitive C-reactiveprotein(hs-CRP).Methods The performance of the AFIAS-50 was evaluated according to American Clinical and Laboratory Standards Institute(CLSI)guidelines in terms of detection limit,precision,accuracy,linearity,referen ce range and interference for hs-CRP measurement.Results The intra-batch precision and inter-batch precision(CV%)ranged from 2.28%to 5.50%and from 1.13%to 5.10%,respectively,which were all with in the propose drange.The detection limit was 0.5 mg/L that well fulfilled the clinical testing requirements.The testing on accuracy showed a good correlation in results between AFLAS-50 and Behring NephelometerⅡ(BNⅡ)(r=0.9973,P<0.05).Validation for reference range showed that the findings from 20 healthy individuals with AFLAS-50 were all below 8 mg/L,which was acceptably in line with the range(0~8.00 mg/L)as quoted by the manufacturer.Triglycerides(TG)and total bilirubin(TBIL)led to<10%impact on the test results,within an range that acceptably met the antiin terference requirements.Concluslon The AFIAS-50 full-automatic fluorescence immunoassay analyzer exhibits good performance for the detection of hs-CRP,is easy to use with automatic sample input that allows for rapid manipulation of a large number of specimens,and thus is useful for diagnosis and treatment in clinical settings.