血清肌钙蛋白Ⅰ纳米胶乳增强免疫比浊法试剂的研制

Development of nano latex enhanced immunoturbidimetric reagent of cardiac troponin I

目的研制一种新的血清肌钙蛋白Ⅰ胶乳增强免疫比浊法检测试剂,以满足各级医院实验室的检测需求。方法用cTnⅠ单克隆抗体和新型纳米胶乳颗粒进行化学交联制备成"吸附抗人cTnⅠ胶乳颗粒",在合适的缓冲液中,通过免疫比浊法原理检测血清cTnⅠ浓度。结果该试剂的空白吸光度、线性范围、分析灵敏度、准确度、测量精密度等性能指标均符合产品注册标准的要求。产品注册检验结果合格。产品临床试验表明产品性能方面均符合标准要求;与对比产品检测结果的量值差异无统计学意义(P>0.05);与对比产品检测结果的两组测试数值差异有统计学意义(P<0.001)。结论血清肌钙蛋白Ⅰ纳米胶乳增强免疫比浊法设计合理、性能指标符合临床要求。本法既可满足大型医院大批量样本的检测,又能满足配备了普通生化分析仪的基层医院实验室测定,值得推广应用。

Objective To develop a new nano-latex enhanced immunoturbidimetric reagent of cardiac troponin I,in order to meet the laboratory detection need of all levels of hospitals. Methods Absorbent anti-human cTnI latex particles were prepared by chemical crosslinking of cTnI monoclonal antibody and new nano-latex particles,then the serum cTnI level was detected in the appropriate buffer solution by immunoturbidimetry. Results The blank absorbance,linear range,sensitivity for analysis,accuracy,precision and other performance indexes of the reagent were all in line with the product registration standard. The test results of product registration were qualified. Clinical trials showed that the performance indexes of the reagent could meet the standard requirement. Compared with the testing results of contrast products,the difference had no statistical significance（ P 〈0. 05）,while significant correlation was found between the reagent and the contrast product in two groups of test values（ P〈 0. 001）. Conclusion The design of serum cardiac troponin Ⅰnano latex enhanced immunoturbidimetry is reasonable and the performance indexes can meet the clinical requirements. This method can not only meet the detection need of large number of samples in large hospitals,but also satisfy the laboratory determination in ordinary grass-roots hospital equipped with biochemical analyzer,worthy of popularization and application.