不同厂家试剂盒检测高致畸病原体弓形体IgM、巨细胞病毒IgM以及风疹病毒IgM的效果分析  

Effect Analysis of Kits from Different Manufacturers in Detecting High Teratogenic Pathogens Toxoplasma Gondii IgM,Cytomegalovirus IgM and Rubella Virus IgM

作　　者：杨小兵 李玉叶 曾勇 刘明凤 聂俊瑜 张雪玲 Yang Xiaobing;Li Yuye;Zeng Yong;Liu Mingfeng;Nie Junyu;Zhang Xueling(Department of Clinical Laboratory,Shenzhen Zhongshan Urology Hospital,Shenzhen 518000,Guangdong Province,China)

机构地区：[1]深圳中山泌尿外科医院检验科,广东深圳518000

出　　处：《中国社区医师》2023年第14期76-78,共3页Chinese Community Doctors

基　　金：深圳市基础研究计划(编号:JCYJ20180228164631121);深圳市基础研究计划(编号:JCYJ20190813161203606)。

摘　　要：目的:分析不同厂家试剂盒检测高致畸病原体(TORCH)弓形体IgM(TOX-IgM)、巨细胞病毒IgM(CMV-IgM)、风疹病毒IgM(RV-IgM)的效果。方法:分别采用罗氏、雅培以及亚辉龙厂家生产的化学发光免疫检测试剂盒,完成132例孕前妇女的血清TOX-IgM、CMV-IgM和RV-IgM检测。比较3个厂家试剂盒检查结果的阳性率,分析亚辉龙试剂盒与罗氏、雅培试剂盒检测结果的一致性。结果:罗氏、雅培、亚辉龙试剂盒检测TOX-IgM、CMV-IgM、RV-IgM的阳性率比较,差异均无统计学意义(P>0.05)。与罗氏生产的试剂盒比较,亚辉龙试剂盒在检测TOX-IgM、CMV-IgM、RV-IgM时的Kappa值分别为0.663、0.796、0.494,具有较高一致性;与雅培生产的试剂盒比较,亚辉龙在检测TOX-IgM和RV-IgM时的Kappa值分别为1.000和0.663,具有高度一致性,而在检测CMV-IgM时,Kappa值为0.385,仅具有一般一致性。结论:国内亚辉龙生产的TORCH IgM检测试剂盒在供应稳定性及性价比上具有较大的优势,与进口试剂盒检测效果的差异甚微,综合考虑,可以将其替代进口试剂盒,在临床广泛应用.Objective:To analyze the effects of detecting high teratogenic pathogens(TORCH)Toxoplasma gondii IgM(TOX IgM),cytomegalovirus IgM(CMV-IgM)and rubella virus IGM(RV-IgM)by kits from different manufacturers.Methods:Serum TOX-IgM,CMV-IgM and RV-IgM of 132 pre-pregnant women were detected by chemiluminescent immunoassay kits manufactured by Roche,Abbott Laboratories and YHLO,respectively.The positive rate of the detection results by using the kits from three manufacturers was compared,and the coincidence of the detection results of the YHLO kit with the Roche kit and Abbott Laboratories kit was analyzed.Results:There was no significant difference in TOX-IgM,CMV-IgM and RV-IgM positive rates among Roche,Abbott Laboratories and YHLO kits(P>0.05).Compared with Roche kit,the Kappa value of YHLO kit in detecting TOX-IgM,CMV-IgM,RV-IgM was 0.663,0.796,0.494,respectively,with a higher coincidence;Compared with Abbott Laboratories kit,the Kappa value of YHLO kit in detecting TOX-IgM and RV-IgM was 1.000 and 0.663,respectively,with a high coincidence;the Kappa value of YHLO kit in detecting CMV-IgM was 0.385,with a general coincidence.Conclusion:The TORCH IgM detection kit produced by China YHLO has great advantages in supply stability and cost performance,and had little difference in the detection effect compared with imported kits.Upon comprehensive consideration,it can replace imported kits and be widely used in clinical practice.

关 键 词：高致畸病原体 弓形体IgM 巨细胞病毒IgM 风疹病毒IgM 

分 类 号：R446.5[医药卫生—诊断学]