MedTech Terms
    The authoritative reference
    All terms
    Clinical & TrialsClinical Evidence

    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 the regulation says
    Analytical sensitivity, often referred to as the Limit of Detection (LoD), is a crucial performance characteristic for in vitro diagnostic (IVD) devices. Regulatory bodies like the FDA and the EU MDR require its thorough characterization to ensure the device can reliably detect the target analyte at low concentrations. This is distinct from clinical sensitivity, which assesses the device's ability to correctly identify individuals with a disease.

    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.

    Examples

    • A manufacturer of an IVD test for a pathogen must determine the analytical sensitivity to ensure the test can detect very low viral loads in patient samples.
    • During pre-market submission for a new immunoassay, the analytical sensitivity data, including the LoD, is presented to regulatory authorities like the FDA to demonstrate the device's performance claims.
    • A laboratory developing a new molecular diagnostic assay meticulously follows CLSI guidelines to establish the analytical sensitivity, ensuring reliable detection of nucleic acids.
    Common pitfalls
    • •Confusing analytical sensitivity with clinical sensitivity can lead to misinterpretation of a device's performance characteristics.
    • •Failing to adequately characterize analytical sensitivity per recognized standards, such as those from CLSI, can result in regulatory non-compliance.
    • •Using inappropriate statistical methods to determine the LoD may lead to inaccurate claims about a device's performance.
    • •Not considering potential interferences or matrix effects when establishing analytical sensitivity can compromise the reliability of the test results.
    • •Neglecting to re-evaluate analytical sensitivity after significant manufacturing changes can invalidate previous performance claims.

    Frequently asked questions

    Analytical sensitivity refers to the lowest concentration of an analyte an assay can detect, while clinical sensitivity refers to the assay's ability to correctly identify individuals with a specific condition. Both are critical for IVD performance evaluation.

    Cross-references

    See also

    Closely related context worth reading.

    Grouped by theme

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-06-20
    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

    Inline markers like [1] jump to the matching reference above.