Sysmex CS5100检测高浓度D-二聚体的稀释验证分析

目的探讨高浓度D-二聚体在抗原过剩情况下是否需要进行稀释处理及最适稀释倍数。方法采用Sysmex CS5100分析仪对D-二聚体质控品与校准品进行检测,计算批内与日间精密度。检测校准品进行线性范围及临床可报告范围验证。对D-二聚体水平小于5mg/L、纤维蛋白降解产物(FDP)20μg/mL的标本进行梯度稀释,检测并计算回收率。对D-二聚体水平大于5mg/L、FDP20μg/mL的标本进行梯度稀释,检测并计算回收率。结果批内及日间精密度分析结果显示,批内及日间变异系数均小于3%。线性范围验证结果显示,0.207~5.170mg/L范围内线性分布良好。临床可报告范围为0.207~165.440mg/L。D-二聚体水平小于5mg/L、FDP20μg/mL时,D-二聚体检测无抗原过剩现象,无需进行梯度稀释检测。D-二聚体水平大于5mg/L、FDP20μg/mL时,D-二聚体检测存在抗原过剩现象,需进行稀释处理。结论当标本D-二聚体水平大于5mg/L、FDP20μg/mL时,D-二聚体检测存在抗原过剩现象,需进行稀释处理,从而保证高浓度D-二聚体标本检测结果的准确性。

Dilution validation of high level D-dimer samples in Sysmex CS5100 instrument

Objective To investigate the necessity of dilution in samples with high concentrations of D-Dimer and optimum dilution multiple.Methods Quality control products and calibration were detected by using Sysmex CS5100 for precision evaluation,including within-batch and between-run precision.Calibration were detected for validation of linear range and clinical reportable.Samples with D-Dimer<5 mg/L and fibrinogen degradation products(FDP)<20 μg/mL were serially diluted and detected to calculate recovery rate.Samples with D-Dimer>5 mg/L and FDP>20 μg/mL were also serially diluted and detected to calculated recovery rate.Results Within-batch and between-run coefficients of variation were both less than 3%.Within the scope of 0.207-5.170 mg/L,the linear distribution was fine.The clinical reportable range was 0.207-165.440 mg/L.For samples with D-Dimer<5 mg/L and FDP<20 μg/mL,no antigen excess phenomenon was found,and gradient dilution was not necessary.For samples with D-Dimer>5 mg/L and FDP>20 μg/mL,there was obvious antigen excess phenomenon,and gradient dilution was required.Conclusion For samples with D-Dimer>5 mg/L and FDP>20 μg/mL,dilution should be performed to ensure the accuracy of detected results.