Comparability of a new turbidimetric digoxin test with other immunochemical tests and with HPLC--a multicenter evaluation

Clin Chem. 1997 Jan;43(1):92-9.

Abstract

A new turbidimetric inhibition immunoassay for digoxin (Tina-quant [a] Digoxin, Boehringer Mannheim) was evaluated in seven laboratories. It can be performed without sample pretreatment with ready-to-use reagents on nondedicated analyzers in combination with routine clinical chemistry. The studies revealed a good analytical performance: lower limit of detection 0.12 microg/L (3 SD from mean of blank); linearity up to 7.5 microg/L; median between-run CVs 8.1% (0.6 microg/L), 2.8% (1.5 microg/L), 1.9% (3 microg/L); mean analytical recovery in control sera 98-102%; slopes from 0.97 to 1.09 and intercepts from -0.28 to 0.10 microg/L in comparison with four immunoassays; and a high resistance to common interferents. The test was more resistant to digoxin-like immunoreactive factor (DLIF) interference than other methods, showing cross-reactivity only in some intensive care patient samples. Among 192 patients in whom DLIF is expected (e.g., pregnant women, patients with renal failure, newborns), 90% of results were < or =0.26 microg/L digoxin. Cortisol showed no cross-reactivity and digoxigenin had a low reactivity. An interlaboratory survey revealed a good comparability of the Tina-quant [a] test with the median of all methods (slope 0.99, intercept -0.06 microg/L). An HPLC method for digoxin based on isocratic separation of samples on an RP-18 column followed by detection by an immunoassay yielded a reasonable comparability with the immunochemical tests with noncritical samples. Divergent results of immunoassays caused by DLIFs or different cross-reactivities with digoxin metabolites or derivatives can be explained by the use of this HPLC method.

Publication types

  • Comparative Study

MeSH terms

  • Anticoagulants
  • Chromatography, High Pressure Liquid*
  • Critical Care
  • Digoxin / blood*
  • Female
  • Humans
  • Immunoassay / methods*
  • Immunoassay / statistics & numerical data
  • Indicators and Reagents
  • Infant, Newborn
  • Laboratories
  • Nephelometry and Turbidimetry / methods*
  • Pregnancy
  • Quality Control
  • Reference Values
  • Renal Dialysis
  • Renal Insufficiency / blood
  • Sensitivity and Specificity

Substances

  • Anticoagulants
  • Indicators and Reagents
  • Digoxin