Clinical Chemistry
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Clinical Chemistry 42: 28-33, 1996;
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Clinical Chemistry, Vol 42, 28-33, Copyright © 1996 by American Association for Clinical Chemistry

Multicenter evaluation of the Abbott IMx CA 15-3 assay

GJ van Kamp, GG Bon, RA Verstraeten, D Lynch, M Krikau, J Fluckiger, A Ruibal and P Kenemans
Department of Clinical Chemistry, Free University Hospital, Amsterdam, The Netherlands.

We describe a new fully automated procedure for the quantitative measurement of CA 15-3: the microparticle enzyme immunoassay (MEIA) technology developed by Abbott Labs. for the IMx automated immunoassay analyzer. The new IMx CA 15-3 test uses two mouse monoclonal antibodies, 115D8 and DF3. The test has a dynamic range to 250 kilounits/L and a minimal detectable dose of CA 15-3 < 0.2 kilounits/L. On dilution, linearity is excellent, with recoveries ranging from 94% to 101%. Studies were conducted at four sites to evaluate the performance characteristics of this assay. The intra- and interassay CVs were < 4.7% and < 5.6%, respectively, and showed a between- laboratory CV < 5.9%. Test results of the Abbott IMx CA 15-3 (y) were correlated with those obtained with the Centocor CA 15-3 RIA (x), a solid-phase heterologous RIA. Linear regression analysis on results for 1973 samples yielded: y = 0.97x - 2.09 (r = 0.9899, Sy/x = 22.2, range 1-4089 kilounits/L).


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G. G. Bon, S. von Mensdorff-Pouilly, P. Kenemans, G. J. van Kamp, R. A. Verstraeten, J. Hilgers, S. Meijer, and J. B. Vermorken
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