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Global Biomarker Standardization Consortium: CSF Reference Method Sub-group

Global Biomarker Standardization Consortium: CSF Reference Method Sub-group. Chairs: Kaj Blennow & Henrik Zetterberg. Goal. Quantify concentration of analyte as accurately as possible in the certified reference material to then be used to compare other methods and platforms available

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Global Biomarker Standardization Consortium: CSF Reference Method Sub-group

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  1. Global Biomarker Standardization Consortium: CSF Reference Method Sub-group Chairs: Kaj Blennow & Henrik Zetterberg

  2. Goal • Quantify concentration of analyte as accurately as possible in the certified reference material to then be used to compare other methods and platforms available • Assumptions • Reference method for AB42 will be independent of antibody • Reference method will be used to measure absolute levels of AB42 in certified reference material (i.e. certified batch of native pre-mortem human CSF) and will be used as standard of truth. • Reference method will be fully validated and compliant with GCP best practice. • Reference method will use universally accepted reference calibrators • Out-of-scope?? • Comparison of correlation of current immunoassay methodologies (Bland-Altman) to “gold standard” reference method • Identifying diagnostic cut-points for individual immunoassays.

  3. Methods to evaluate (for pros/cons) • MRM published by Waters et al… • Absorbance/HPLC based methods • PPD (Randy Jenkins)- Assay from ICAD poster • Caprion/Covance - • Proteome Sciences - “validated” ab42 assay • C2N – quant ab42 and “total ab” assay • Immunoassay based approaches • MSD, Myriad RBM, INNX/Fujirebio • … • Note: need request validation reports from each.

  4. Reference Methods Issues • Issue: are we considering what is available today or what may need to get developed • Consideration of pre-analytic methods and their impact on the analytical methods • Oligomer vs monomer of Ab42 • What is the minimum validation required? What is the quality standard? • What is overall target goal? FDA clearance or approval, operate in research space only? • Resources to achieve the goals? • Suggest pull EMA opinions based on BMS submission regarding CSF biomarkers • MSD-RUO initially, require more than MSD alone if tied to drug or indication, working on how take to next level, what are clinical study design and samples for a PMA . . .- Individual Dx would use the reference method as part of the PMA. • Invite DX companies: OCD, Roche to the “table”, CRO have done “validated” Pfizer/ICON, BARC, and Covance • Issue: is method/assay validated and available? Where should it be done? • What should the universal reference standard be – how will this be decided? • Immunoassays see many fragments of AB and tau – which fragments will be measured by the reference method?

  5. Terms to be Defined • Certified Reference Material • Universal Reference Calibrators • NIST • IFCC • IRMM • Quality Control Samples • Reference method • Traceability • Validation • Primary calibrators • Reference calibrators • Working calibrators

  6. Actions – Nov 29th 2011 • Group to start compiling validation reports for measurement of AB42, T-Tau by MRM mass spec or HPLC. • Holly – C2N, PPD • OMAR – Waters/Millipore • Charlotte – Proteome Sciences • Caprion/Covance - Bob

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