目的 研发一种配套床边快速散射比浊仪使用的全血检测超敏C反应蛋白试剂盒.方法 根据乳胶增强散射比浊法的原理,用溯源至NIBSC标准品的工作校准品制定射频卡,含有表面活性剂的试剂1及含有致敏胶乳的试剂2与样品反应后,根据射频卡的标准曲线换算浓度.结果 本试剂盒线性范围0.05 ～ 30mg/L,灵敏度为0.05 mg/L,批内CV值分别为0.85％和0.42％,日间CV值分别为1.85％和1.65％,对血红蛋白、胆红素、甘油三酯有较强的抗干扰能力.结论 本试剂盒与商品化试剂配套生化仪检测系统比对,结果相关性较好,符合临床快速诊断的要求.%Objective To evaluate ahs-CRP assay kit for point-of-care testingnephelometry analyzer,whichcan be used to detect CRP with whole blood sample.Methods According to the principle oflatex-enhanced nephelometry,making the cardwith product calibration tracing to the NIBSC standard,the samplesreact with the reagent 1 which contains the surfactant and the reagent 2 containing the sensitive latex,and then convert the concentration according to the standard curve of the card.Results The measurement range was0.05-30mg/L,sensitivity was0.05mg/L,intra-variation coefficients were0.85％ and 0.42％ and inter-dayvariation coefficients werel.85％ and 1.65％ respectively.The kit also has high anti-jamming capability towards hemoglobin,bilirubin and triglyceride.Conclusion The hs-CRP assay system showed high correlation with the regents on market used in automatic biochemical analyzer.The hs-CRP kit could meet the requirements of rapid and accurate clinical diagnosis.
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