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.

Why it matters

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

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.

Sources

CLSI EP17 · CLSI
ISO 14155 Standard Page · ISO
FDA - Clinical Trials and Human Subject Protection · FDA

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