降钙素原生物素-链霉亲和素酶联免疫吸附分析法的建立

Development of biotin-streptavidin amplified ELISA for procalcitonin

目的建立生物素一链霉亲和素酶联免疫吸附分析（biotin．streptavidinamplifiedELISA，BA．ELISA）法半定量检测人血清中降钙素原含量。方法通过双抗体夹心法，结合生物素一链霉亲和素系统的放大作用，建立降钙素原的半定量检测方法。并对该试剂的各项性能指标进行评价。结果该方法的最低检测限为0．12mg／mE，线性范围为0．12～20ng／mL，回收率为98．59％。分析内和分析间变异系数分别为4．9％～16．8％和7．1％～14．9％。与降钙素原结构类似物及血清中常见的干扰物质特异性良好。通过对73例血清样本进行检测分析，当阈值为0．5ng／mL时，敏感性和特异性分别为100％和96．0％。结论本研究建立的降钙素原生物素一链霉亲和素酶联免疫吸附分析法具有灵敏、简便、准确等特点，具有良好的应用前景。

Objective To develop a semi-quantitative biotin-streptavidin amplified ELISA for detecting procalcitonin in hunman serum. Methods Depending on the sandwich immunoassay and the biofin-streptavidin amplified system, a semi-quantitative kit for procalcitonin was developed and evaluated. Results The lowest detectable limit of the procalctionin kit was 0.12 ng/mL and in the range of 0.12~20 ng/mL. The recovery rate was 98.59%. The intra- and inter-assay coefficients of variation were 4.9%--16.8% and 7.1%,--14.9%. None interference were detected with the analogues or principals commonly in human serum. The sensitivity and specificity were 100% and 96.0% when the cut-off value was at 0.5 ng/mL, respectively. Conclusion A semi-quantitative biotinstreptavidin amplified ELISA for procalcitonin has been established. It is sensitive, simple and accurate.