巨细胞病毒IgM抗体检测试纸条的改良与性能评价  

Improvement and performance evaluation of test strip for cytomegalovirus IgM antibody detection

作　　者：陈亨莉 CHEN Heng-li(INTEC PRODUCTS,INC.,Xiamen 361022,Fujian Province,China)

机构地区：[1]英科新创(厦门)科技股份有限公司,福建厦门361022

出　　处：《医疗卫生装备》2023年第7期39-43,共5页Chinese Medical Equipment Journal

摘　　要：目的:改良巨细胞病毒IgM抗体检测试纸条,以消除IgG抗体干扰,提高检测准确度。方法:该试纸条采用胶体金免疫层析法制备,以鼠抗人IgM抗体作为金标抗体。首先,制备胶体金标记抗体,并制成胶体金垫。其次,沿着层析方向在硝酸纤维素(nitrocellulose,NC)膜上依次设置IgG抗体拦截线I、检测线T及对照线C,并在检测线T处包被1.5 mg/mL的巨细胞病毒重组抗原,在对照线C处包被0.5 mg/mL的羊抗鸡IgY抗体,在拦截线I处包被3.0 mg/mL的鼠抗人IgG抗体。最后,将胶体金垫、NC膜、吸水纸、样品垫等粘贴在聚氯乙烯底板上,制成试纸条,并对其性能进行评价。结果:该试纸条可有效降低样本中效价≤1 280的IgG抗体对检测结果的干扰,且在检测国家参考品时的准确度、最低检出限及重复性均符合要求。该试纸条与10种相近病原体无交叉反应,且与酶联免疫吸附试剂盒的检测结果具有较高的一致性。结论:改良后的巨细胞病毒IgM抗体检测试纸条可消除IgG抗体干扰,且检测高效方便、准确度高,能更好地满足基层单位临床检验的需要。Objective To modify the test strip for cytomegalovirus IgM antibody detection to eliminate IgG antibody interference and improve detection accuracy.Methods A test strip was prepared by colloidal gold immunochromatography with the mouse anti-human IgM antibody as the gold standard antibody.The colloidal gold-labeled antibody were produced,and then the colloidal gold pad was made.A nitrocellulose(NC) membrane was set with an IgG antibody intercept line I,detection line T and control line C sequentially along the direction of chromatography,and coated with 1.5 mg/mL recombinant cytomegalovirus antigen at the detection line T,with 0.5 mg/mL goat anti-chicken IgY antibody at the control line C and with 3.0 mg/mL mouse anti-human IgG antibody at the intercept line I.The colloidal gold pad,NC film,absorbent paper and sample pad were pasted onto a polyvinyl chloride backing to form the test strip,then the test strip underwent performance evaluation.Results The test strip could effectively reduce the interference of IgG antibodies with the titre not higher than 1 280 in the sample on the test results,and met the requirements for accuracy,limit of detection and repeatability when used to detect the national reference.There were no cross reactions found between the test strip and 10 kinds of similar pathogens,and the test strip had high consistency with the ELISA kit.Conclusion The modified test strip for cytomegalovirus IgM antibody eliminates the interference of IgG antibody effectively and has high detection efficiency and accuracy,and can be used for the clinical laboratory tests of elementary institutions.

关 键 词：巨细胞病毒 IGM抗体 试纸条 胶体金免疫层析法 IgG抗体干扰 

分 类 号：R318[医药卫生—生物医学工程] R446.6[医药卫生—基础医学]