Catalog Number: 11820796160
Immunoassay for the in vitro quantitative determination of digoxin in human serum and plasma. Measurements are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure proper therapy.
Store at 2-8 °C.
Traceability: This method has been standardized by weighing United States Pharmacopoeia (USP) digoxin reference material into analyte free human serum.
0.4-5.0 ng/mL or 0.51-6.4 nmol/L (defined by the Limit of Quantitation and the maximum of the master curve). Values below the Limit of Quantitation are reported as < 0.4 ng/mL or < 0.51 nmol/L. Values above the measuring range are reported as > 5.0 ng/mL or > 6.4 nmol/L (or up to 10.0 ng/mL or 12.8 nmol/L for 2-fold diluted samples).
Limit of Blank, Limit of Detection and Limit of Quantitation
Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.
Precision was determined using Elecsys reagents, samples and controls in a protocol (EP5-A3) of the CLSI (Clinical and Laboratory Standards Institute): 2 runs per day in duplication each for 21 days (n = 84). The following results were obtained:
A comparison of the Elecsys Digoxin assay (y) with the predicate Elecsys Digoxin assay (x) which is standardized against the USP reference material using clinical samples gave the following correlations (ng/mL):
For the co-analytes tested, the following relative co-analyte reactivities were found: