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.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2006年第2期156-158,共3页
Chinese Journal of Pharmaceutical Analysis