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- W2050435629 abstract "A need exists to document laboratory proficiency to (1) compare results produced by different analytical techniques and (2) ensure consistency of results from multiple testing sites.To enable concentration-controlled studies of sirolimus to proceed with confidence, proficiency-testing schemes were put in place at laboratories selected to act as reference laboratories. The feasibility of establishing an ongoing proficiency-testing scheme was addressed with respect to sample stability. The scheme was then used to test proficiency for the measurement of sirolimus in 3 blinded samples each month.The method chosen for measurement of sirolimus was a prototype microparticle enzyme immunoassay. Initially, 15 laboratories were asked to analyze a series of 85 blinded samples that tested their inaccuracy, repeatability, and reproducibility for the measurement and their ability to dilute over-range samples competently. Both blood samples spiked with sirolimus and pooled blood samples from patients receiving the drug were circulated to a maximum of 50 laboratories.Overall, both inaccuracy and imprecision were acceptable by predefined criteria. Inaccuracy for the immunoassay (percentage difference of the measured value against the nominal value) averaged -5% (95% CI, -9% to -1%). The mean percentage difference between the immunoassay and a high-performance liquid chromatographic assay with mass-spectrometric detection for the measurement of sirolimus in pooled samples (n = 5) from patients receiving the drug was 29% (95% CI, 24% to 34%).The techniques documented here as part of the International Sirolimus Proficiency Testing Scheme could be applied to other clinical studies requiring protocol-driven dosing adjustments based on sirolimus measurements, irrespective of analytical technique used." @default.
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- W2050435629 date "2000-01-01" @default.
- W2050435629 modified "2023-09-27" @default.
- W2050435629 title "Proficiency-testing issues relating to sirolimus" @default.
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- W2050435629 doi "https://doi.org/10.1016/s0149-2918(00)89028-1" @default.
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