J Clin Pathol Qual Control.  2000 Dec;22(2):251-254.

Analytical Evaluation for Serum Digoxin Measurements

• Kang MS
• Kim SJ
• Nahm CH
• Choi JW
• Pai SH

Abstract

BACKGROUND: We evaluated the ACS:180(R) (Chiron Diagnostics, MA, USA) and Vitros 250R (Johnson &Johnson Clinical Diagnostics, Inc., NY, USA) in the measurements of digoxin levels and compared its results to those of the TDxFLx(R) (Abbott Laboratories, Il, USA) nationwide used for therapeutic drug monitoring (TDM) in order to assess the utility of the ACS:180R and Vitros 250(R) as TDM instruments.
METHODS
48 candidates for TDM were randomly chosen to measure digoxin using the TDxFLx(R), ACS:180(R), and Vitros 250(R), The within-run and between-run precisions of 3 instruments were respectively determined for digoxin. Correlations between TDxFLx(R) and ACS:180(R), andbetween TDxFLx(R) and Vitros 250(R) also were respectively determined for quantitative measurement of digoxin.
RESULTS
The coefficients of variation (CV) for the within-run of the TDxFLx(R) were 7.40, 3.55, 4.28% for low, medium, high concentration, respectively, and for the CVs of between-run were 9.93, 6.66, 4.76%, respectively. The CVs for the within-run of ACS:180(R) were 2.46% for medium concentration, and for between-run were 3.86%. The CVs for the within-run of Vitros 250(R) were 3.89, 2.32% for Vitros Performance Verifier (PV) I and II, and for between-run were 3.66, 2.36%. Correlations between TDxFLx(R) and ACS:180(R), between TDxFLx(R) and Vitros 250(R) also were 0.9831, 0.9692 for measurement of digoxin, respectively.
CONCLUSIONS
The TDxFLx(R), ACS:180(R) and Vitros 250(R) were proved to be good precisions for quantitative analysis of digoxin. The results obtained by ACS:180(R) and Vitros 250(R) correlate well with those of the TDxFLx(R).

MeSH Terms

Digoxin*
Drug Monitoring
Digoxin