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Quantitation of interference in digoxin immunoassay in renal, hepatic, and diabetic disease
Author(s) -
Tzou Meir C.,
Reuning Richard H.,
Sams Richard A.
Publication year - 1997
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1016/s0009-9236(97)90193-4
Subject(s) - digoxin , immunoassay , high performance liquid chromatography , medicine , pharmacology , derivatization , chromatography , therapeutic drug monitoring , coefficient of variation , reproducibility , chemistry , drug , immunology , heart failure , antibody
A comparison of the results of a newly developed fluorescence‐derivatization/HPLC method and a commercial immunoassay method (ACA, Dupont) for the measurement of serum digoxin concentrations in patients indicates that (1) the results from the ACA method agree well with those from the HPLC method in patients with cardiovascular disease but without renal, diabetic, and liver disease, (2) serum digoxin concentrations determined by the ACA method are overestimated in patients with renal, diabetic, or liver disease, and (3) the steady‐state serum concentrations of hydrolyzed and reduced metabolites are relatively insignificant in patients receiving digoxin therapy, including patients with renal failure. The excellent reproducibility of the HPLC and immunoassay methods (coefficient of variation < 9.0%), together with the demonstrated specificity of the HPLC method with respect to potential interference from digoxin metabolites, endogenous digoxin‐like immunoactive substances, and coadministered drugs and their metabolites, allows quantitation of the degree of interference in digoxin immunoassays under actual therapeutic drug monitoring conditions. Clinically significant interferences (0.3 to 1.1 ng/ml) with immunoassay determination were found in the majority of patients in all three diseases studied. Clinical Pharmacology & Therapeutics (1997) 61 , 429–441; doi: