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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. Analytical sensitivity is not the same as clinical (diagnostic) sensitivity, which measures how often a test is positive in people who have the condition. For IVDs, analytical sensitivity is part of the analytical performance evidence under IVDR Annex I and Annex XIII and in FDA submissions. Studies typically use dilution series of known material across reagent lots, instruments and days.
    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.

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    Sources

    3 sources

    Sources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.

    Tier 1Binding law and standards· 2Tier 2Regulator guidance and consensus· 1
    Link health: 3 verified· last checked 2026-06-20
    CLSI·1ISO·1FDA·1
    1. 1
      CLSI EP17
      Tier 1 Verified
      CLSIclsi.org
    2. 2
      ISO 14155 Standard Page
      Tier 1 Verified
      ISOiso.org
    3. 3
      FDA - Clinical Trials and Human Subject Protection
      Tier 2 Verified
      FDAfda.gov

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