A multicentre evaluation of the CA 15-3 assay, CA 19-9 assay and CA 125 II assay on the Bayer Immuno 1 System.

The analytical performance of the tumour markers CA 15-3 assay, CA 19-9 assay and Ca 125 II assay on the Bayer Immuno I System was studied according to a revised version of the ECCLS guidelines (Haeckel R. In: Evaluation methods in laboratory medicine, Weinheim, VCH Verlag 1993:47-69) in a multicentre evaluation involving five laboratories. Determination of the 3 analytes generated more than 6000 data. On the Bayer Immuno I System, the imprecisions of the CA 15-3 assay, CA 19-9 assay and CA 125 II assay were better than those found for comparison methods. The median recovery over all five laboratories of system assigned values in control sera was within the 1-s range for the three tumour marker assays. No deviation of linearity could be detected experimentally for all assays. Results for patients' samples showed acceptable agreement between the Bayer Immuno 1 system and several different comparison methods in most cases. One exception was the CA 15-3 assay in comparison with the MCA assay from Roche Diagnostic Systems, where the large difference in values is due to the use of different antibodies and calibrators in the two assays. No carry-over effects could be detected. The selective Bayer Immuno 1 system is fully automated; its practicability was rated as high.