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Related Experiment Videos

Proficiency-testing issues relating to sirolimus.

K Jones1, A Johnston, D W Holt

  • 1Analytical Unit, St. George's Hospital Medical School, London, England.

Clinical Therapeutics
|May 24, 2000
PubMed
Summary
This summary is machine-generated.

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Establishing a sirolimus proficiency testing scheme demonstrated acceptable laboratory accuracy and precision. This ensures reliable sirolimus measurements across different analytical techniques and testing sites for clinical studies.

Area of Science:

  • Clinical Chemistry
  • Pharmacology
  • Analytical Chemistry

Background:

  • A critical need exists for documenting laboratory proficiency to ensure reliable analytical technique comparison and consistency across multiple testing sites.
  • Standardized proficiency testing is essential for accurate clinical trial data and patient management.

Purpose of the Study:

  • To establish and assess an ongoing proficiency-testing scheme for sirolimus measurement.
  • To evaluate the feasibility of the scheme concerning sample stability and laboratory performance.
  • To enable concentration-controlled sirolimus studies with high confidence.

Main Methods:

  • A prototype microparticle enzyme immunoassay was employed for sirolimus measurement.
  • Fifteen laboratories initially analyzed 85 blinded samples to assess inaccuracy, repeatability, and reproducibility.

Related Experiment Videos

  • Pooled blood samples from patients and spiked samples were circulated to up to 50 laboratories.

    • Main Results:

    • Laboratory inaccuracy and imprecision met predefined acceptable criteria.
    • The immunoassay showed an average inaccuracy of -5% compared to nominal values.
    • A 29% mean difference was observed between the immunoassay and liquid chromatography-mass spectrometry for patient samples.

    Conclusions:

    • The International Sirolimus Proficiency Testing Scheme successfully documented laboratory performance.
    • The established techniques are applicable to other clinical studies requiring precise sirolimus measurements for dosing adjustments.
    • This scheme supports reliable sirolimus quantification irrespective of the analytical method used.