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Clinical Chemistry 41: 1730-1737, 1995;
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Clinical Chemistry, Vol 41, 1730-1737, Copyright © 1995 by American Association for Clinical Chemistry

Variation in measurement of prostate-specific antigen: importance of method and lot variability

MH Wener, PR Daum and MK Brawer
Department of Laboratory Medicine, University of Washington Medical Center, Seattle 98195, USA.

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.


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Copyright © 1995 by the American Association for Clinical Chemistry.