国产梅毒螺旋体酶联免疫诊断试剂盒质量评价  

Quality evaluation on ELISA kits of treponema pallidum

作　　者：武峰[1] 

机构地区：[1]山东省泰安市红十字会中心血站,271000

出　　处：《检验医学与临床》2007年第11期1050-1051,共2页Laboratory Medicine and Clinic

摘　　要：目的比较国产梅毒螺旋体酶联免疫诊断试剂盒的质量差异,优选适宜于献血者梅毒螺旋体检测的试剂盒。方法应用中国药品生物制品检定所提供的梅毒螺旋体国家参考品和卫生部临床检验中心提供的梅毒螺旋体临界值质控血清,对所购进的试剂盒进行质量评价。结果5个厂家试剂的阴性符合率、阳性符合率、总符合率、灵敏度和精密度存有一定差别,个别厂家试剂有假阳性出现和临界值质控血清未检出。结论不同厂家的试剂质量存在明显差异,因此试剂使用前必须进行质量抽检,综合评价其质量。选择灵敏度高、特异性强的试剂,以提高献血者梅毒螺旋体的检测质量。Objective To find out the difference in quality among the various domestic ELISA kits of treponema pallidum （TP） and to choose the best one for the blood donators＇ selection. Methods Various ELISA kits of TP were evaluated one by one based on the national TP panel. Results There was definite difference among 5 brands of kits in the negative coincident rate, positive coincident rate and total coincident rate. Some difference existed in the sensitivity and accuracy. The false positive sample was presented and the critical concentration sample which should be detected was not checked out in some brands. Conclusion There is obvious difference in various brands of kits. So it is necessary to have spot check before using ELISA kit of TP and to choose the TP ELISA kit with high sensitivity and specificity for improving the quality of donators＇ TP test.

关 键 词：酶联免疫吸附试验 梅毒螺旋体 试剂 质量评价 

分 类 号：R446[医药卫生—诊断学]