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Quality assurance program for cyclosporin G (OG37-325)
1Department of Laboratory Medicine and Pathology, University of Alberta, Edmonton, Canada.
Therapeutic Drug Monitoring
|August 1, 1995
Summary
Therapeutic drug monitoring of Cyclosporine-G (CsG) revealed significant assay variability. Assays adapted from Cyclosporine-A (CsA) showed lower accuracy and specificity, highlighting the need for CsG-specific methods.
Area of Science:
- Pharmacology
- Clinical Chemistry
- Analytical Chemistry
Background:
- Cyclosporine-G (CsG) is an analogue of Cyclosporine-A (CsA) currently in clinical trials.
- Therapeutic drug monitoring is crucial for CsG efficacy and safety.
Purpose of the Study:
- To assess the performance of laboratories measuring CsG.
- To evaluate different immunoassay and chromatography methods for CsG quantification.
Main Methods:
- External quality assurance program involving North American centers.
- Analysis of data from High-Performance Liquid Chromatography (HPLC), Radioimmunoassay (RIA), and Fluorescence Polarization Immunoassay (FPIA) methods.
- Comparison of assay precision, accuracy, and specificity.
Main Results:
- Fluorescence Polarization Immunoassay (FPIA) demonstrated the highest precision (CVs < 10%).
- Radioimmunoassay (RIA) showed the lowest accuracy, with 74% of results deviating > 20% from target values.
- FPIA and RIA methods exhibited higher CsG values and lower specificity compared to HPLC.
Conclusions:
- Existing assays adapted for CsG measurement, particularly FPIA and RIA, present challenges in accuracy and specificity.
- High-Performance Liquid Chromatography (HPLC) offered better specificity for parent drug measurement.
- Development and utilization of CsG-specific assays are recommended for routine clinical use.