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Evaluation of the New Thermo- Fisher QMS Everolimus Assay

Evaluation of the New Thermo- Fisher QMS Everolimus Assay Julie Tran , J. Ray, K. Gao , P. Williams, M.James. Everolimus is a mammalian target of rapamycin inhibitor ( mTOR ) and it is used in the prevention of transplant rejections by preventing T-cell activation.

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Evaluation of the New Thermo- Fisher QMS Everolimus Assay

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  1. Evaluation of the New Thermo- Fisher QMS Everolimus Assay Julie Tran, J. Ray, K. Gao, P. Williams, M.James

  2. Everolimusis a mammalian target of rapamycin inhibitor (mTOR) and it is used in the prevention of transplant rejections by preventing T-cell activation. • Performed on the Thermo Fisher CDx90 analyser using QMS ( Quantitative Microparticle System) Everolimus Reagents • Turbidimetric immunoassay • Assay time: 10 mins per sample • Evaluation included: • Reagent stability under various conditions • Comparison with HPLC-MSMS • Sensitivity • Specificity • Precision • Specimen stability • Evaluation was conducted according to the CLSI guidelines (formerly NCCLS)

  3. Comparison with HPLC-MSMS

  4. Reagent Stability • Ran 3 levels of QC, twice a day, on consecutive days ( except wkends) for 2 weeks or until end of reagents. • 3 tests were set up: • Reagents to be left uncapped at all times • Reagents to be capped at the end of the day • Reagents to be capped at the end of each run • Each test was initially calibrated and whenever necessary. Ie, when at least 1 QC levels exceeded the 2 SD • Mean, SD and CV were calculated

  5. Cumulative CV

  6. Analytical Sensitivity Limit of Detection was 0.086ng/mL Functional Sensitivity Limit of Quantitation was 0.237ng/mL Intra-assay Precision Level 1 mean : 2.70ng/mL SD: 0.09 CV: 3.30% Level 2 mean: 5.77ng/mL SD: 0.14 CV: 2.43% Level 3 mean: 16.97ng/mL SD: 0.33 CV: 1.96% Inter-assay Precision Level 1 mean : 3.99ng/mL SD: 0.26 CV: 6.42% Level 2 mean: 8.02 ng/mL SD: 0.29 CV: 3.64% Level 3 mean: 16.18 ng/mL SD: 0.48 CV: 2.99%

  7. Specimen Stability

  8. QMS Everolimus on the UKNEQAS External QAP Program Sample 54- 59

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