SARS抗体酶联诊断试剂盒比较  

Comparison of the SARS antibody detect kits

作　　者：范行良[1] 英志芳[1] 王剑峰[1] 易敏[1] 李长贵[1] 方捍华[1] 周铁群[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《药物分析杂志》2006年第2期156-158,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:对国内 SARS 抗体(IgG 和/或总抗体)检测试剂盒的质量进行比较和评价。方法:本文选用4种国内 SARS 抗体ELISA 检测试剂盒分别检测已知同样样品,并对结果进行比较。结果:4种试剂盒的阳性参考品符合率均为100%(18/18),阴性参考品符合率均为100%(20/20);3批 D 试剂盒的精密性(10/10)试验的 CV 值均在3%以下,A 试剂盒及3批 B 试剂盒的的 CV 值均在5%～10%之间,3批 C 试剂盒的 CV 值均在10%～15%之间;B、C、D3种试剂盒的灵敏度均达到5/7或以上,其中第1批 C 试剂盒及前2批 D 试剂盒灵敏度较高,均达到了7/7。结论:4种试剂盒均有较好的灵敏度、特异性及检出率。Objective： Comparison and evaluation of the SARS antibody （ IgG and/or total） detect kits made in domestic. Method： Four SARS antibody detect kits were used for the detection of detect the same approved references. Result：The positive references corresponding to rates of the four kits （ totally 10 lots ） were all 100% （ 18/18 ）. The negative references corresponding to rates of such kits were all 100% （20/20）. The intra - assay CVs of the D kits were all under 3% （10/10） ,whereas the intra- assay CVs of A and B kits were between 5% and 10% ,and the C kits were between 10% and 15%. The sensitivity of each lot of the four kits was 5/7 or above. One lot of C kits and two lots of D kits showed the highest sensitivity （7/7）. Conclusion：All the four kits showed the acceptable sensitivity and specificity.

关 键 词：SARS 诊断试剂盒 

分 类 号：R917[医药卫生—药物分析学]