免疫比浊法测定血清淀粉样蛋白A的钩状效应及其解决方案

Determination of the hook effect of serum amyloid A through immunoturbidimetry and the solution

目的探讨研制的血清淀粉样蛋白A(SAA)试剂盒的钩状效应及其解决方法。方法以83个西门子定值血清为研究对象,分析研制的SAA试剂盒的线性范围、准确度和精密度等性能;用试剂盒检测超高值血清样本,验证是否存在钩状效应,并研究稀释法能否解决钩状效应。结果SAA试剂盒线性范围为1~200 mg/L,测定值与样本定值之间的偏差在20%以内,精密度CV均<3.0%。浓度超出200 mg/L样本的实测值明显低于定值,浓度范围在1~1000 mg/L的拟合曲线未出现明显的下降趋势,而1~2000 mg/L、1~3000 mg/L拟合曲线出现明显的下降趋势,存在钩状效应。用稀释法测定异常值样本,测定值与定值相近。结论所发现的非正常测定值由钩状效应所致,稀释法能够解决钩状效应问题。

Objective To investigate the hook effect of the developed serum amyloid A(SAA)kit and the solution.Methods The linear range,accuracy and precision of the developed SAA kit were analyzed with 83 Siemens qualified value serum samples as research objects.The kit was used to detect the ultra-high value serum samples to verify the existence of hook effect,and whether the dilution method could solve the hook effect was also researched.Results The linear range of SAA kit was 1-200 mg/L,the deviation between the measured value and the sample value was within 20%,and the precision CV was all less than 3.0%.The measured value of samples with concentration over 200 mg/L was obviously lower than the fixed value,and the fitting curve with concentration in the range of 1-1000 mg/L didn't show any obvious downward trend.However,the fitting curves with concentration in the range of 1-2000 mg/L and 1-3000 mg/L showed obvious downward trend with hook effect.Samples with abnormal values were measured by dilution method,and the measured values were close to the fixed values.Conclusion The abnormal measured value is caused by hook effect.Dilution method can solve the problem of hook effect.