摘要
目的 为了严格控制麻疹IgM抗体ELISA检澳6试剂的质量，消除试剂误差产生的检测错误。方法 根据麻疹IgM抗体定量测定结果，选择标准曲线线性良好部分血清标本制备外对照血清，并计算出外对照血清对于相应公司试剂的参考值范围。结果实验测得外对照血清的活性为48．2～60．5Units／ml，对于海泰公司试剂的OD参考值范围是0.630～0．674。用此外对照血清对2个公司共5个批号的试剂盒做复核验证，发现海泰公司批号为20040806试剂盒检测结果失控，而正是此批号试剂对116份血清标本的检测阳性率和符合率明显低于其它试剂盒。还验证了此外对照血清的有效活性在4℃条件下可至少维持6个月。结论对于只有阴／阳性定性指示的ELISA检测试剂盒，制备特定OD值范围的外对照质控血清很有必要。
Objective To accurately control the quality of measles virus IgM ELISA kits and eliminate the false results caused by reagents. Methods Based on measles virus IgM quantification, standardized extra control serum was selected from the scale of standard curve with good linearity and its referential value was measured by kit of certain company. Results The biological activity of extra control serum was 48.2 - 60.5 uits/ml, and its OD referential range measured by the kit of ＂Hai Tai＂ company was 0. 630 ～ 0. 674. Through the usage of extra control serum in 116 samples＇detection by kits of 5 batches from 2 companies,we found that the batch 20040806 kit of ＂ Hai Tai＂ not only lost control,but also showed lower positive and coincident rate in contrast to others.The activity of extra control serum could be maintained at least for 6 months at 4℃. Conclusion It is necessary to prepare extra control serum with definite OD range from those measles virus IgM ELISA kits only having qualitative referential positive/negative serum.
出处
《应用预防医学》
2006年第4期201-203,共3页
Applied Preventive Medicine
基金
广西壮族自治区疾病预防控制中心资助项目
合同编号:20030010
