新型空间位阻化学发光技术应用研究

Application research of new steric hindrance chemiluminescence technology

目的基于空间位阻化学发光(SPARCAL)技术建立乙肝表面抗原(HBsAg)试剂盒,评估其分析性能并进行临床比较。方法采用吖啶标记多抗、样本和辣根过氧物酶标记的抗体形成夹心法试剂进行精密性、线性范围及临床相关性比对。结果建立的HBsAg试剂盒分析内精密性变异4.23%,分析间精密性变异5.7%;在0.01~165 mIU/mL浓度范围内线性参数R达到0.99;与雅培HBsAg试剂盒临床相关性达到0.98。结论新型空间位阻化学发光技术具有很好的发展前景。

【Objective】To establish a hepatitis B surface antigen(HBsAg)kit based on steric hindrance chemiluminescence(SPARCAL)technology,and evaluate its analytical performance and clinical comparison.【Methods】Acridine labeled polyclonal antibody,sample and antibody labeled antibody were used to form sandwich reagent for precision,linear range and clinical relevance comparison.【Results】The precision variation of HBsAg kit was 4.23%within analysis and 5.7%between analysis.The linear parameter R reached 0.99 in the concentration range of 0.01~165 mIU/mL.The clinical correlation with Abbott HBsAg kit reached 0.98.【Conclusion】The new steric hindrance chemiluminescence technology has a good development prospect.