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A microparticle enzyme immunoassay to measure sirolimus
D W Holt1, M Moreton, K Laamanen
1Analytical Unit, St George's Hospital Medical School, London, UK. d.holt@sghms.ac.uk
Transplantation Proceedings
|April 6, 2005
Summary
A new immunoassay for measuring sirolimus (a drug used in kidney transplant patients) is a viable alternative to high-performance liquid chromatography (HPLC). While showing a slight bias, it offers improved accessibility for local clinical centers.
Area of Science:
- Clinical Chemistry
- Pharmacology
- Transplant Medicine
Background:
- Therapeutic drug monitoring of sirolimus is crucial for patient management.
- High-performance liquid chromatography (HPLC) is the standard but requires specialized facilities, limiting its use to central laboratories.
- This necessitates the development of more accessible measurement techniques.
Purpose of the Study:
- To evaluate a new immunoassay for sirolimus measurement.
- To compare the immunoassay's performance against HPLC.
- To assess its suitability for routine clinical use in local centers.
Main Methods:
- Single-center assessment of a novel sirolimus immunoassay.
- Comparison of immunoassay results with a reference chromatographic technique (HPLC).
- Evaluation of calibration accuracy, reproducibility, and sensitivity.
Main Results:
- The immunoassay demonstrated good calibration accuracy and excellent reproducibility (better than 6% at 11 ng/mL).
- Sensitivity was found to be better than 2 ng/mL, meeting clinical requirements.
- A mean positive bias of approximately 20% was observed compared to HPLC, likely due to metabolite cross-reactivity.
Conclusions:
- Despite analytical bias, the new immunoassay is a practical alternative to HPLC for sirolimus measurement.
- The assay's performance characteristics make it suitable for implementation in local clinical laboratories.
- This offers improved accessibility for therapeutic drug monitoring of sirolimus.