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    Clinical & TrialsClinical EvidenceLoD / LoQ

    Limit of Detection / Limit of Quantitation

    Lowest analyte concentrations an assay can reliably detect (LoD) or quantify (LoQ).

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

    Definition

    LoD is the lowest concentration distinguishable from a blank with stated probability. LoQ is the lowest concentration that can be quantitatively measured with stated accuracy and precision (per CLSI EP17 / EP05).

    What this means in practice

    Critical performance characteristics for IVD claims, especially for infectious disease and oncology assays where low-burden detection drives clinical utility.

    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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