D-二聚体胶体金免疫层析法定量检测试剂盒性能评价

Performance Evaluation of D-dimer Colloidal Gold Immunochromatography Quantitative Detection Kit

目的:评价采用胶体金免疫层析法自主研制的一种D-二聚体定量检测试剂盒的方法学性能。方法:检测试剂盒的检测限、线性范围、准确度、批内精密度、抗干扰性,并评价其与对比试剂的相关性。结果:本试剂盒检测限不高于0.1μg/mL;线性范围为0.2~5.0μg/mL,线性相关性为0.99;准确度小于15%;批内精密度小于10%;当样本中胆红素<200 mg/L,胆固醇<2500 mg/L,抗坏血酸<2500 mg/L时,对本试剂盒的检测无显著影响。用227人份的标本进行比对分析,显示本试剂盒与参比试剂盒检测相关性良好(R=0.994)。结论:本试剂盒属于床边检验(POCT),其线性范围宽,检测限、精密度、准确性、抗干扰性、比对相关性均能满足临床检测需要。

Object:To evaluate the quality and performance of the newly self-developed D-Dimer test kit which is established by Colloidal Gold Immunochromatography.Methods:Determine the limitation of detection,the linear range,accuracy,precision and the anti-inference ability of this kit as well as its correlation with contrast agents.Results:The limitation of detection is less than 0.1μg/mL,the linear ranges of the product are 0.2~5.0μg/mL and the correlation coefficient is 0.99.The precisions are less than 15%and the variations of accuracy fall within 10%.And there is no significant effect found when the concentration of bilirubin in the sample is less than 200 mg/L,cholesterol less than 2500 mg/L and the ascorbic acid less than 2500 mg/L.Additionally,a very good correlation(R=0.994)with Nanjing Jidan product is found by testing 227 human samples.Conclusion:This kit belongs to point-of-care testing product.The results of the linear range,the limitation of detection,precision,accuracy,anti-interference,correlation show that our D-Dimer test kit can be used in clinical diagnosis.