ELISA法HBsAg试剂盒检测限确定及技术对策  

Investigation of Cut-off Value in HBsAg Test by ELISA and the Corresponding Management

作　　者：李俊立[1] 

机构地区：[1]湖北省荆州市中心医院检验部,湖北荆州434020

出　　处：《现代检验医学杂志》2005年第2期35-37,共3页Journal of Modern Laboratory Medicine

摘　　要：目的　探讨不同来源HBsAgELISA试剂盒的灵敏度及相应cut-off(CO)值及灰区的设置。方法　观察模拟不同运输条件(2～8℃与2 5℃/2 4h)下的HBsAg试剂盒检测各低水平的HBsAg质控血清的S/CO值,分析其敏感度与cut off值。结果　在2～8℃与2 5℃/2 4h条件下运输的试剂在检测1 0 ,0 .2 5ng/ml水平HBsAg时的吸光度(A)值有显著差异(P =0 . 0 11,0 . 0 0 1) ,不同厂家试剂盒(A、B、C)在1 .0 ,0 . 5 ,0 . 2 5ng/ml水平上的A值均有显著性差异(P <0. 0 5 ) ,试剂盒B按照说明书规定CO值与该文建议的CO值所对应的ROC曲线下的面积分别为0. 6 5 6 /0 . 75 0。结论　使用新试剂盒时应先评估其灵敏度,并根据灵敏度重新设置CO值及灰区。Objective Investigating the sensitive degree of vary reagents and set of the cut-off value and grey-area in HBsAg test by ELI SA.Methods Used HBsAg-reagents from 3 companies,transpor ted under 2～8 ℃ and 25 ℃/24hours examined low-level standard serum,analyzed each sensitive degree and cut-off value.Results The abso rbency of the reagents under diferrent temperature had prominence statistical di fference(P=0.011,0.001)at 1.0 and 0.25 ng/ml level,and reagents A, B and C also had prominence statistical difference (P<0.05) each other at 1.0,0.5 a nd 0.25 ng/ml level.For reagent B,the area under receive operation curve corre spond two cut-off values were 0.656 and 0.750,by regulated the exponent and adv ice of author.Conclusion Before HBsAg test using new reag ent,it is necessary to valuate the sensitive degree,and set new cut-off value a nd grey-area basing it.

关 键 词：ELISA CUT-OFF值 灰区 ROC 

分 类 号：R446.61[医药卫生—诊断学]