Blood-based biomarkers (BBMs) are now formally included in diagnostic workflows for Alzheimer’s disease (AD), but should never replace comprehensive clinical evaluation.
Only BBMs meeting strict sensitivity (≥90%) and specificity (≥75%) criteria are recommended as diagnostic triage tools; higher specificity (≥90%) is required to substitute for CSF or PET confirmation.
Current guidelines are brand-agnostic, reflecting rapid test evolution and limited head-to-head comparative evidence.
BBMs promise improved accessibility and prompt diagnosis, but real-world implementation must address pre-analytic, analytic, and interpretive challenges.
