摘要
目的评价国产试剂与进口试剂检测效果。方法选择了2种试剂(一种国产试剂,一种进口试剂),以2010年1月至2011年12月的样本进行检测,分析了2种试剂检测结果的特异性、灵敏度和假阳性率;用国家参考品血清盘对2种试剂进行考核,讨论了他们的符合率、精密度。结果进口试剂和国产试剂的灵敏度均为100%。在特异性和假阳性率方面不存在显著差异。经过国家参考品复核,2种试剂的符合率、精密度达到相关要求。结论国产试剂的检测效果与进口试剂不存在差异。
Objective To evaluate the effect of domestic reagents imported reagent. Methods Two kinds of reagents (a domestic reagents, an imported reagent) to January 2010 December to 2011 samples for testing, analysis of the two kinds of reagent test results, specificity, sensitivity and false-positive rate; assess- ment of the national reference serum plate of two kinds of reagents, discussed their compliance rate of precision. Results The sensitivity of the import reagent and domestic reagent were 100%. There was no significant differ- ence in the specificity and false-positive rate. After the national reference review, the coincidence rate of two kinds of reagents, the precision of the relevant requirements. Conclusion domestic reagents detect the effect of imported reagents there is no difference.
出处
《中国实用医药》
2012年第21期34-35,共2页
China Practical Medicine
关键词
进口试剂
国产试剂
HIV检测
精密度
Imported reagents
Domestic reagents
An HIV test
Precision