【摘要】 目的建立灵敏、准确的高敏C反应蛋白(hsCRP)检测方法。方法以金磁微粒为载体,辣根过氧化物酶-鲁米诺-双氧水为化学发光体系,建立hsCRP的检测方法。对方法的线性、灵敏度、精密度、准确性等进行评估。对233例临床样本进行检测,与德国西门子散射比浊法检测结果进行比对。结果该方法在(0.15~25.00)mg/L范围内呈现优良线性(R2=0.9937),最低检测限为0.076 mg/L,批内精密度<10.00%、批间精密度<15.00%,平均回收率为97.80%。与德国西门子散射比浊法相比,具有相关性、一致性良好的特点。结论利用金磁微粒免疫化学发光技术可成功检测hsCRP。更多还原

【Abstract】 Objective To develop a sensitive,accurate detection method for high sensitive C-reactive protein（ hs CRP）.Methods With the Gold Mag particle as the solid phase carrier, horseradish peroxidase（ HRP）-lunimo-H₂O₂ as the chemiluminescence reaction system,we established a chemiluminescent immunoassay for hs CRP detection. Linear range,sensitivity,precision,accuracy and other indicators were evaluated. hs CRP level of 233 clinical human serum specimens were determined and compared by two different methods: the Gold Mag particle-based magnetic chemiluminescence enzyme-linked immunoassay established in this study,and the commercialized scattering immunoturbidimetric assay from Germany SIEMENS.Results The chemiluminescent immunoassay for hs CRP based on Gold Mag particle had a good linear relationship between0. 15 mg / L and 25 mg / L（ R2= 0. 9937）,with the detection limit of 0. 076 mg / L. The intra-assay precision was less than10. 00% and the inter-assay precision was less than 15. 00%. The average recovery rate for accuracy was 97. 80%. In the contrast experiment of 233 clinical human serum specimens,the results obtained using the approach established in this study showed a high correlation and consistency with scattering immunoturbidimetric assay from Germany SIEMENS. Conclusion Gold Mag particle-based magnetic chemiluminescence enzyme-linked immunoassay for hs CRP has been successfully developed.更多还原