Wener M H, Daum P R, Brawer M K
Department of Laboratory Medicine, University of Washington Medical Center, Seattle 98195, USA.
Clin Chem. 1995 Dec;41(12 Pt 1):1730-7.
Equivalence between Hybritech Tandem and Abbott IMx PSA methods have been reported by some but not all previous investigators. To determine reasons for these differing conclusions, we measured serum PSA with three different lots each of IMx and Tandem-E kits. Overall, mean IMx results were significantly lower than Tandem-E results; however, for selected sera, the IMx results were consistently higher than the Tandem-E results. Lot-to-lot differences for the IMx method were significantly greater than those with the Tandem-E method. Most IMx/Tandem-E lot-to-lot comparisons had linear regression slopes that differed significantly from 1.0, but some did not. Conclusions concerning the equivalence of the IMx and the Tandem-E methods can be influenced both by variations in the proportions of free PSA in sera in tested populations and by lot-to-lot differences in the IMx method.
一些但并非所有先前的研究者都报告过Hybritech Tandem法与雅培IMx PSA法之间的等效性。为了确定这些不同结论的原因，我们使用IMx和Tandem-E试剂盒的三个不同批次分别检测了血清PSA。总体而言，IMx的平均结果显著低于Tandem-E的结果；然而，对于选定的血清，IMx的结果始终高于Tandem-E的结果。IMx方法的批次间差异显著大于Tandem-E方法。大多数IMx/Tandem-E批次间比较的线性回归斜率与1.0有显著差异，但有些没有。关于IMx和Tandem-E方法等效性的结论可能会受到受试人群血清中游离PSA比例的变化以及IMx方法批次间差异的影响。
