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目的应用约登指数(Youden index)验证常用抗-HIV、抗-TP ELISA血液筛查试剂盒的阳性判断值(S/CO)及其“灰区”设置的必要性。方法利用SPSS17.0软件,计算国家卫计委临床检验中心(NCCL)牵头组织的国内常用血液筛查试剂多中心评估项目中的抗-HCV、抗-TP ELISA试剂不同S/CO值时的灵敏度、特异性及约登指数[约登指数=(灵敏度+特异性)-1],以S/CO值为横坐标,约登指数为纵坐标,绘制曲线,观察每种试剂各自在最大约登指数下的S/CO值。结果在所评估的7家抗-HIV ELISA试剂盒中,有1种试剂的S/CO值为1、其余6种试剂的S/CO值均为5时,其约登指数达最大。在所评估的5家抗-TP ELISA试剂盒中,有2种试剂的S/CO值为1、2种试剂的S/CO值为3和1种试剂的S/CO值为5时,其约登指数达最大。结论国内常用血液筛查试剂多中心评估项目中的抗-HIV和抗-TP ELISA试剂盒灵敏度和特异性最佳时均为S/CO≥1(亦即试剂盒自身设定的判定值),因此均不必设置“灰区”。
Objective To verify the positive judgment (S / CO) of the commonly used anti-HIV, anti-TP ELISA blood screening kit and the necessity of its “gray zone” setting using the Youden index. Methods SPSS17.0 software was used to calculate the sensitivity of anti-HCV and anti-TP ELISA reagents with different S / CO values in the multicentre evaluation program of domestic commonly used blood screening reagents led by the National Committee for Clinical Cardiology (NCCL) , Specificity and Youden index [Youton index = (sensitivity + specificity) -1], the S / CO value as the abscissa, the Youden index as the ordinate, draw the curve to observe each of the reagents in each of the maximum about Gordon Under the index S / CO value. Results One of the seven anti-HIV ELISA kits evaluated had an S / CO value of 1 and the other 6 tested S / CO values of 5, resulting in a maximum Youden index. Two of the five anti-TP ELISA kits evaluated had an S / CO value of 1, two reagents had an S / CO value of 3 and one of the reagents had an S / CO value of 5, Youden index up to maximum. Conclusion The sensitivity and specificity of the anti-HIV and anti-TP ELISA kits used in multicentre evaluation of commonly used blood screening reagents are S / CO≥1 (that is, the determination value of the kit itself) So do not have to set “gray area ”.