December 1, 2000Therapeutic Drug Monitoring
Predictive Performance Study of Two Digoxin Assays in Subjects With Various Degrees of Renal Function
Why the study?
Do fluorescence polarization immunoassay and radioimmunoassay accurately measure serum digoxin concentrations compared to LPLC/RIA in patients with varying degrees of renal function?
Population
18 men and women with various degrees of renal function, stratified into 3 age- and gender-matched groups…
Comparison
Fluorescence polarization immunoassay and… vs Combined low-pressure liquid chromatography/RIA…
Design
Cohort
Follow-up
5-7 days
Authors
Discussion
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Member takes
Implication
Small biases in FPIA/RIA unlikely clinically relevant for digoxin monitoring in renal impairment; supports use but leaves open prospective validation.
Structured PICO
Do fluorescence polarization immunoassay and radioimmunoassay accurately measure serum digoxin concentrations compared to LPLC/RIA in patients with varying degrees of renal function?
P
Population
18 men and women with various degrees of renal function, stratified into 3 age- and gender-matched groups (n=6 each): group I (Clcr < 10 mL/min), group II (Clcr = 10-50 mL/min), and group III (Clcr > 50 mL/min).
I
Intervention
Fluorescence polarization immunoassay (FPIA, Abbott TDx Digoxin II) and radioimmunoassay (RIA, Kallestad Labs) for measuring serum digoxin concentrations after a single 10 microg/kg intravenous digoxin dose.
C
Comparator
Combined low-pressure liquid chromatography/RIA (LPLC/RIA) digoxin assay.
O
Outcome
Predictive performance (bias and precision) in measuring serum digoxin concentrations.surrogate
Both FPIA and RIA assays demonstrate acceptable predictive performance for measuring serum digoxin concentrations across varying degrees of renal function, with bias magnitudes that are unlikely to be clinically relevant.
Cite This Study
Spinler et al. (2000) studied this question.