Problems in determining levels of free digoxin in patients treated with digoxin immune FAb

Determination of free digoxin levels in patients treated with digoxin immune FAb has long been a problematic area in clinical laboratory testing. The older radioimmunoassays resulted in inaccurate and variable results due to the competition of the administered drug with the radioactively labelled forms. The 1995 Physicians' Desk Reference continues to state that digoxin immune FAb will interfere with digitalis immunoassay measurements. This statement, however, is based primarily on the RIA methods. We evaluated the Stratus digoxin assay and the TDX digoxin II assay. Increasing amounts of immune FAb were added in a stepwise fashion to 12 patient samples containing high normal to elevated digoxin levels. Results showed a progressive decrease in digoxin levels when assayed with the Stratus kit. However, five patient samples tested with the TDX kit resulted in constant digoxin values despite the presence of increasing digibind levels. These results suggest that the Stratus method measures free digoxin, whereas the TDX method measures the total digoxin. Measurement of digoxin by the Stratus method is simple and quick. The Stratus digoxin assay may be an accurate and objective way of measuring free digoxin levels in patients on digoxin immune FAb.