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Related Experiment Videos

A unitized enzyme-labeled immunometric digoxin assay suitable for rapid testing.

R G Sommer1, T L Belchak, M L Bloczynski

  • 1Miles Inc., Diagnostics Division, Elkhart, IN 46515.

Clinical Chemistry
|February 1, 1990
PubMed
Summary

A new enzyme-labeled immunometric assay offers rapid and accurate digoxin measurement in serum or plasma. This automated method is ideal for quick therapeutic drug monitoring at decentralized healthcare sites.

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Area of Science:

  • Clinical Chemistry
  • Immunoassay Technology
  • Analytical Biochemistry

Background:

  • Digoxin is a critical medication requiring precise therapeutic drug monitoring.
  • Existing methods for digoxin measurement can be time-consuming or require specialized laboratory facilities.
  • The need for rapid, accurate, and accessible digoxin assays is crucial for patient management.

Purpose of the Study:

  • To develop and validate a novel enzyme-labeled immunometric assay for quantifying digoxin in human serum or plasma.
  • To assess the performance characteristics of the new assay, including speed, accuracy, and precision.
  • To evaluate the suitability of this assay for use in decentralized clinical settings.

Main Methods:

  • Utilized an enzyme-labeled immunometric assay with unitized, compartmentalized reagents.

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  • Employed an automated sample-processing instrument and a reagent strip with the Ames Seralyzer reflectance photometer.
  • Measured enzyme activity, directly proportional to digoxin concentration, for rapid quantification.
  • Performed assay validation using control samples and clinical serum samples, comparing results with established methods (fluorescent polarization immunoassay and RIA).

    • Main Results:

    • The assay demonstrated high precision with within-run coefficients of variation (CVs) ranging from 2.3% to 3.8% and between-run CVs from 1.5% to 2.6%.
    • Results from clinical samples showed excellent correlation (r > 0.96) with established fluorescent polarization immunoassay and radioimmunoassay methods.
    • The entire test procedure, including sample processing and measurement, was completed in under 15 minutes.

    Conclusions:

    • The developed enzyme-labeled immunometric assay provides a rapid, convenient, and accurate method for digoxin measurement.
    • The assay's performance and speed make it highly suitable for therapeutic drug monitoring in decentralized settings like emergency rooms, urgent-care centers, and physician offices.
    • This method facilitates timely clinical decisions for patients on digoxin therapy.