Measurement of cyclosporine in plasma of cardiac allograft recipients by fluorescence polarization immunoassay

R. Rondanelli, M. B. Regazzi, L. Gastaldi, P. Legnazzi, P. Abelli

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

The Abbott TDx fluorescence polarization immunoassay (FPIA) procedure for measuring cyclosporine A (CsA) was evaluated and compared with the Sandoz polyclonal radioimmunoassay (CsA RIA kit) method. This drug assay was evaluated for precision, calibration, stability, and accuracy. Within-run precision studies utilizing 25 replicate analyses of the three control preparations (containing CsA in the 60-800 ng/ml range) resulted in coefficients of variation (CV) ranging from 1.0 to 9.1%. The CVs of between-run precision determined by assaying the same control drug levels for five consecutive working days ranged from 3.9 to 4.6%. Calibration curve stability was assessed by examining the drift in control values over a 2-week period. Maximum plasma ranged from 82.6 to 108.2%. Four hundred plasma samples were obtained from 30 heart-transplant patients during the first 6 months of CsA therapy and each sample was analyzed simultaneously by TDx and RIA. Linear regression analysis of the results obtained for each patient (x = RIA, y = FPIA) revealed the following mean values: r = 0.87, (CV = 13.7%), slope = 1.47 (CV = 39.2%). Moreover, the concentration of CsA was determined in 35 patient samples both by TDx and high-performance liquid chromatography (HPLC). FPIA results up to 12 times higher than HPLC results have been noted.

Original languageEnglish
Pages (from-to)182-186
Number of pages5
JournalTherapeutic Drug Monitoring
Volume12
Issue number2
Publication statusPublished - 1990

Fingerprint

Fluorescence Polarization Immunoassay
Cyclosporine
Allografts
Fluorescence
Polarization
Plasmas
High performance liquid chromatography
Calibration
High Pressure Liquid Chromatography
Transplants
Drug and Narcotic Control
Linear regression
Regression analysis
Pharmaceutical Preparations
Radioimmunoassay
Linear Models
Assays
Regression Analysis

Keywords

  • Cyclosporine A
  • Fluorescence polarization immunoassay
  • High-performance liquid chromatography
  • Radioimmunoassay

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Pharmacology
  • Biochemistry, Genetics and Molecular Biology(all)
  • Biochemistry
  • Health, Toxicology and Mutagenesis
  • Public Health, Environmental and Occupational Health
  • Toxicology

Cite this

Measurement of cyclosporine in plasma of cardiac allograft recipients by fluorescence polarization immunoassay. / Rondanelli, R.; Regazzi, M. B.; Gastaldi, L.; Legnazzi, P.; Abelli, P.

In: Therapeutic Drug Monitoring, Vol. 12, No. 2, 1990, p. 182-186.

Research output: Contribution to journalArticle

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abstract = "The Abbott TDx fluorescence polarization immunoassay (FPIA) procedure for measuring cyclosporine A (CsA) was evaluated and compared with the Sandoz polyclonal radioimmunoassay (CsA RIA kit) method. This drug assay was evaluated for precision, calibration, stability, and accuracy. Within-run precision studies utilizing 25 replicate analyses of the three control preparations (containing CsA in the 60-800 ng/ml range) resulted in coefficients of variation (CV) ranging from 1.0 to 9.1{\%}. The CVs of between-run precision determined by assaying the same control drug levels for five consecutive working days ranged from 3.9 to 4.6{\%}. Calibration curve stability was assessed by examining the drift in control values over a 2-week period. Maximum plasma ranged from 82.6 to 108.2{\%}. Four hundred plasma samples were obtained from 30 heart-transplant patients during the first 6 months of CsA therapy and each sample was analyzed simultaneously by TDx and RIA. Linear regression analysis of the results obtained for each patient (x = RIA, y = FPIA) revealed the following mean values: r = 0.87, (CV = 13.7{\%}), slope = 1.47 (CV = 39.2{\%}). Moreover, the concentration of CsA was determined in 35 patient samples both by TDx and high-performance liquid chromatography (HPLC). FPIA results up to 12 times higher than HPLC results have been noted.",
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