A Clinical Evaluation of Fluorescence Excitation Transfer Immunoassay for Quantitation of Serum Digoxin Level

Abstract

The advance system (Syva®) in conjunction with fluorescence excitation transfer immunoassay reagents was available for use in determining serum drug levels. We evaluated this system for determination of serum digoxin level.
Within-run CV's were determined to be lower than 3.29% for 10 replicate assays on digoxin spiked sample at 4 concentrations. Between-run CV's were determined to be lower than 3.30% for 10 different days in duplicate assays on digoxin spiked sample over the 14-day period. Hemolysis or bilirubinemia sample showed a substantial interfere on determining serum digoxin level by FETIA with the advance system.
We compared the Syva advance system with 4 commercial based digoxin assays. A linear regression analysis was performed on the data by parallel determination of 100 patient samples with wide range of concentrations. The advance system has been proved highly automated, and its precision and correlation with other methods were practically acceptable.