基于G6PD/6GPD比值法的葡萄糖-6-磷酸脱氢酶测定试剂盒性能分析

Performance Analysis of Determination Kit Using G6PD/6PGD Ratio for Glucose-6-Phosphate Dehydrogenase

目的:对基于G6PD/6GPD比值法的葡萄糖-6-磷酸脱氢酶测定试剂盒进行性能分析。方法:从试剂盒灵敏度、重复性及与对照试剂盒进行临床对比方面评价试剂盒的性能。结果:试剂盒对G6PD和6PGD的分析灵敏度分别为0.03 U/g Hb和0.02μg/ml;20次检测质控品C1和C2,变异系数分别为4.18%和6.12%;该试剂盒对1000例临床样本的敏感度、特异性及总符合率均为1.00,误诊率为0.001,漏诊率为0,P=1.000>0.05,差异无统计学意义。Kappa=0.962(P<0.01),广州丰华公司的试剂盒与对照试剂盒的临床检测结果具有高度的一致性。结论:广州丰华公司的试剂盒操作简单,结果可靠,由于该方法能检出G6PD缺乏症杂合子,弥补了荧光法检测G6PD缺乏症的不足,更适合推向市场。

Objective：To assess the determination kit using G6PD/6PGD ratio for Glucose-6-phosphate dehydrogenase.Method：Evaluate the sensitivity and repeatability of the kit from Guangzhou Fenghua,and compare the clinical results between it and the reference kit.Results：The sensitivity of this kit for G6 PD and 6PGD were 0.03 U/g Hb and 0.02 μg/ml,respectively.The variable coefficient of 20 test results for quality control C1 and C2 were 4.18% and 6.12%,respectively.And compared to the reference kit using1000 clinical tests,all the sensitivity、specificity and total consistent rate was 1.00,the mistake diagnostic rate was 0.001,the omission diagnostic rate was 0,P=1.0000.05,there was no significant difference.The clinical tests between Guangzhou Fenghua and the reference kit have high consistency with Kappa = 0.962（ P〈 0.01）.Conclusion：The kit from Guangdong Fenghua is easily operated and reliable,it will be a perfect product in the market as a supplyment for fluorescence regent kit to diagnose heterozygote of G6 PD deficiency.