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. Author manuscript; available in PMC: 2019 May 1.
Published in final edited form as: Nat Rev Neurol. 2018 Nov;14(11):639–652. doi: 10.1038/s41582-018-0079-7
  • Tier 1 – validated biomarkers

    • Markers with strong performance data that have successfully completed initial validation studies in subsequent reports or in a multi-centre setting with more than 120 patients.

  • Tier 2 – high-performing biomarkers

    • Markers with good performance data that have not completed validation studies. Markers in this category are further divided into subgroups depending on the intended use and number of patients.

      • 2A: Specificity and sensitivity >80%, or specificity or sensitivity >85%*, with an intended use of early detection, prediction or differential diagnosis and greater than 120 subjects

      • 2B: Specificity and sensitivity >80%, or specificity or sensitivity >85%*, with an intended use of early detection, prediction or differential diagnosis and less than 120 subjects

      • 2C: Specificity and sensitivity >80%, or specificity or sensitivity >85%*, with an intended use of diagnosis

      • 2D: Same criteria as Tier 2A–C, with markers having applications in both blood and CSF.

  • Tier 3 – promising candidate biomarkers

    • Innovative markers with promising performance data but have not yet produced higher performance results in clinical settings.

*

Along with an adequate, non-zero score on the other parameter