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    Analytical Sensitivity

    An IVD's ability to detect small quantities of an analyte.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    Analytical sensitivity is the lowest amount of analyte that an assay can reliably detect, often expressed as the limit of detection (LoD) per CLSI EP17.

    What this means in practice

    Distinct from clinical (diagnostic) sensitivity. Both must be characterized for IVD submissions and are central to the IVDR performance evaluation.

    Cross-references

    See also

    Closely related context worth reading.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    CLSI·1ISO·1FDA·1
    1. 1
      CLSI EP17
      Verified
      CLSIclsi.org
    2. 2
      ISO 14155 Standard Page
      Verified
      ISOiso.org
    3. 3
      FDA - Clinical Trials and Human Subject Protection
      Verified
      FDAfda.gov

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