CAJ | 학술논문

目的：建立检测鳞状上皮细胞癌抗原(squamous cell carcinoma antigen，SCC-Ag)的磁分离酶联免疫法(mag-netic affinity immunoassay，MAIA)。方法：采用双抗体夹心法，用异硫氰酸荧光素(fluorescein isothiocyanate，FITC)和碱性磷酸酶(alkaline phosphatase，AP)分别标记识别不同表位的两种抗 SCC-Ag 单克隆抗体(mAb) T17和 H390，以耦联羊抗FITCmAb包被的免疫磁珠作为固相载体，APS-5作为显色底物，建立检测SCC-Ag的磁分离酶联免疫法。结果：成功实现了用磁分离酶联免疫法对SCC-Ag的定量检测，其检测灵敏度为0.22μg/mL，线性范围0~50μg/mL，批内CV 7%~8%，批间CV 6%~9%。添加回收率为97%。与雅培AxSYM微粒子化学发光检测结果对比，相关系数为0.973。结论：磁分离酶联免疫法的检测结果接近进口同类试剂的检测结果，为开发一种高质量的SSC-Ag测定试剂盒提供实验数据。
목적：건립검측린상상피세포암항원(squamous cell carcinoma antigen，SCC-Ag)적자분리매련면역법(mag-netic affinity immunoassay，MAIA)。방법：채용쌍항체협심법，용이류청산형광소(fluorescein isothiocyanate，FITC)화감성린산매(alkaline phosphatase，AP)분별표기식별불동표위적량충항 SCC-Ag 단극륭항체(mAb) T17화 H390，이우련양항FITCmAb포피적면역자주작위고상재체，APS-5작위현색저물，건립검측SCC-Ag적자분리매련면역법。결과：성공실현료용자분리매련면역법대SCC-Ag적정량검측，기검측령민도위0.22μg/mL，선성범위0~50μg/mL，비내CV 7%~8%，비간CV 6%~9%。첨가회수솔위97%。여아배AxSYM미입자화학발광검측결과대비，상관계수위0.973。결론：자분리매련면역법적검측결과접근진구동류시제적검측결과，위개발일충고질량적SSC-Ag측정시제합제공실험수거。
Objective:To establish magnetic affinity immunoassay(MAIA) for detecting SCC-Ag. Methods: The immunoassay was based on antibody sandwich immunoassay, two monoclonal antibodies T17,H390 were used for conjugating with alkaline phosphatase and with fluorescein isothiocyanate ( FITC ) respectively , which incorporated magnetic solid phase separation . Magnetic beads were coupled with sheep anti-FITC antibody as solid phase , and APS-5 was used as a substrate to set up MAIA for detecting SCC-Ag. Results: Established the MAIA for detecting SCC-Ag successfully. The sensitivity of the MAIA method was 0.22 μg/mL, the linear range was 0-50 μg/mL, the intra-and inter-assay variation were 7%-8% and 6%-9%respectively. The addition recovery rate was 97%. The correlation coefficient was 0.973 in comparison with Abbott AxSYM. Conclusion: SCC-Ag MAIA kit is better than SCC-Ag RIA and ELISA kit, which can provide experimental data for the de-velopment of a high quality of the SSC-Ag assay kit.