摘要
目的对美国伯乐医学产品公司(Bio-Rad Laboratories,inc).研制生产的血红蛋白A2/F/A1c检测试剂盒(HPLC法)的临床应用性能进行评价。方法对430例婚检、产检人员的血样本分别用研究试剂和对比试剂进行HbA2和HbF分析检测。结果 HbA2研究试剂与对比试剂比较的临床性能指标为:阳性符合率为99.50%,阴性符合率为100%,总符合率为99.77%,2种试剂的相关系数r为0.9917。HbF检测的阳性符合率为93.22%,阴性符合率为99.73%,总符合率为98.84%,2种试剂的相关系数r为0.9972。结论研究试剂和对比试剂在临床检测上具有较好的一致性和等效性。
Objective To evaluate the clinical application of hemoglobin A2/F/A1 c test kit in screening β - thalas- saemias. Methods Four hundred and thirty blood samples were analyzed for HbA2 and HbF by hemoglobin A2/ F/Alc test kit and β -thalassaemias detection kit respectively. Results For the analysis of HbA2 and HbF, the percentage of positive agreements of the two reagents were 99.5% and 93.22% , respectively. Both of the percent of negative agreements were 100% and 99.73% , and the correlation coefficients Were 0. 9917 and 0. 9972, respective- ly. Conclusion There was a desirable consistency and equivalence between the two reagents.
出处
《中国卫生检验杂志》
北大核心
2013年第10期2266-2268,共3页
Chinese Journal of Health Laboratory Technology
