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Related Experiment Videos

Radioreceptor assay for sirolimus

N Goodyear1, K L Napoli, J N Murthy

  • 1Department of Laboratory Medicine, Children's National Medical Center, Washington, DC 20010, USA.

Clinical Biochemistry
|October 1, 1996
PubMed
Summary
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A new radioreceptor assay (RRA) for sirolimus (rapamycin) in whole blood shows excellent correlation with HPLC. This assay is precise, accurate, and offers a simpler, faster alternative for therapeutic drug monitoring.

Area of Science:

  • Pharmacology
  • Analytical Chemistry
  • Clinical Diagnostics

Background:

  • Sirolimus (rapamycin) is an immunosuppressant drug with a narrow therapeutic index.
  • Accurate therapeutic drug monitoring of sirolimus is crucial for patient outcomes.
  • Existing methods like HPLC can be time-consuming and complex.

Purpose of the Study:

  • To develop and validate a novel radioreceptor assay (RRA) for quantifying sirolimus in whole blood.
  • To compare the performance of the developed RRA against the established high-performance liquid chromatography (HPLC) method.

Main Methods:

  • A direct methanol extraction was employed for sample preparation.
  • The developed RRA was used to analyze 45 patient samples.
  • Assay validation included precision, recovery, and drug interference studies.

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Main Results:

  • The RRA demonstrated sensitivity down to 1.0 microgram/L of sirolimus equivalents.
  • A high correlation coefficient (0.977) was observed when comparing RRA results to HPLC.
  • Excellent between-run precision (CVs ranging from 5.9% to 12.9%) and high recovery rates (93-103%) were achieved.
  • No significant interference was noted from common co-administered drugs like cyclosporine.

Conclusions:

  • The developed RRA for sirolimus is a reliable, precise, and accurate method.
  • The RRA offers a significant advantage over HPLC due to its reduced complexity and time requirements.
  • The RRA has strong potential for automation and routine clinical use in sirolimus monitoring.