Evaluation of the Boehringer Mannheim ES 300 immunoassay analyzer and comparison with enzyme immunoassay, fluorescence polarization immunoassay, and radioimmunoassay methods

Abstract

The ES 300 (Boehringer Mannheim Diagnostics, Indianapolis, IN) is a new automated immunoassay analyzer intended for the quantitative determination of a wide range of analytes. We compared its performance to enzyme immunoassay (EIA), fluorescence polarization immunoassay (FPIA), and radioimmunoassay (RIA) methods for cortisol, digoxin, ferritin, prolactin, T4-uptake, total-T3, and TSH. The ES 300 methods showed excellent precision and the manufacturers' linearity claims were met in all cases. Cortisol, prolactin, total-T3, and TSH showed no bias and acceptable correlation with other methods. Digoxin, ferritin and total T4 showed positive bias but acceptable correlation. The ES 300 T4-uptake correlated poorly with the TDx method and showed positive bias; however, these assays appear comparable (although deficient) in diagnostic sensitivity when compared to TSH and T4 data for the same patient population. In all, we found the ES 300 to be an acceptable instrumental alternative for the high volume immunoassay laboratory.