What do sensitivity controls in quantitative assays ensure?

Sensitivity controls in quantitative assays are designed to evaluate the ability of a test to correctly identify the smallest amount of an analyte that can be measured reliably. This characteristic is crucial for ensuring that the assay is sensitive enough to detect low levels of the target substance.

By ensuring that sensitivity controls yield positive results at the lower limit of detection, laboratories can confirm that the assay can effectively differentiate between true positive results (where the target analyte is present at low concentrations) and false negatives (where the assay fails to detect the analyte when it is actually present).

This level of precision is critical, especially in fields like molecular diagnostics, where detecting even minimal amounts of DNA, RNA, or other biomarkers can be essential for diagnosing diseases or monitoring treatment efficacy.