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May 4, 2025

ANVISA revises sanitary classification rule for ultra-sensitive CRP

Ultra-sensitive CRP is used to monitor and screen the risk of cardiovascular events, enabling prognosis and preventive monitoring of inflammation and infections in the blood vessels walls, before the manifestation of clinical symptoms, already identifying inflammatory changes in apparently healthy patients.

It is a positive acute phase protein, a marker of systemic inflammation, which increases in response to various types of injury, particularly bacterial infections.

Considering the multiple applications and contexts of use, there was a differentiation in the risk classification of the parameters C-Reactive Protein – CRP (class II) and ultra-sensitive CRP (class III), based on Rule 3 (i) in force in RDC # 830/2023. The classification of ultra-sensitive CRP in risk class II reflects its role as a complementary test in risk assessment, without implying treatment decisions that put the patient’s life at imminent risk.

Technical Note 17/2025/SEI/GEVIT/GGTPS/DIRE3/ANVISA