IPV-D抗原检测试剂参考品的制备及标定

Preparation and Calibration of Reference Reagents for Testing Antigens of IPV-D

目的制备一套可对IPV-D抗原检测进行质量控制的参考品。方法用组织培养的方法制备出3套用于IPVD抗原Ⅰ、Ⅱ、Ⅲ型的参考品;每个型别参考品有22份样品,包含10份阳性参考品,10份阴性参考品,1份灵敏度参考品,1份精密性参考品;每个型别参考品经9人次标定。结果 IPV-Ⅰ、Ⅱ、Ⅲ型参考品中10份阳参全部阳性,10份阴参全部阴性,灵敏度标定值分别1413. 13、1684. 66、1561. 95DU/ml,精密性参考品平均CV值分别为4. 52%、6. 54%、5. 68%;参考品37℃放置5天,反复冻融5次稳定性良好。结论制备的IPV-D抗原检测试剂参考品经各项试验检测结果合格,可用于IPV-D抗原检测试剂的质控。

Objective To prepare a group of reference products for quality control over testing antigens of IPV-D.Methods Three groups of reference products were prepared for typeⅠ,ⅡandⅢantigens of IPV-D via tissue culturing,including 10 positive reference products,10 negative reference products,1 reference product for sensitivity and 1 reference product for precision.Each type of reference product was calibrated by 9 persons.Results All 10 positive reference products were positive and 10 negative reference products were negative among IPV-Ⅰ,ⅡandⅢantigens,where the calibrated sensitivity was 1413.13DU/ml,1684.66DU/ml and 1561.95DU/ml respectively,while the average CV of the precise reference products was 4.52%,6.54%and 5.68%respectively.After they were placed at 37℃for 5 days,the reference products showed high stability after repeated freezing and thawing.Conclusion The reference products,which were prepared for testing antigens of IPV-D,were tested to be conforming in different tests and could be used for quality control over the reagents for testing antigens of IPV-D.