Abbott TDx, Dade Stratus, and Du Pont aca automated digoxin immunoassays compared with a reference radioimmunoassay...

Automated digoxin immunoassays with the Abbott TDx, Dade Stratus, and Du Pont aca were evaluated against an RIA similar to the Centers for Disease Control Candidate Reference Method. All three automated methods correlated poorly with the reference method. Particularly disconcerting were the falsely increased values (up to 0.6 micrograms/L) obtained by the Stratus for blank specimens. We discuss the inaccuracies of the results in terms of sample matrix effects, calibrator problems, lot-to-lot reagent variation, and our laboratory requirements. We strongly support the acceptance of the CDC Candidate Reference Method for digoxin and the establishment of a standardized protocol for determining the accuracy of digoxin measurements.