Analysis of Clinical Key Points for CE-IVDR Certification Based on CRP

C-reactive protein (CRP) is an acute-phase reactant protein, produced by the liver in response to inflammation within the body. When the body is infected or tissues are damaged, activated cells such as macrophages and other white blood cells produce cytokines like interleukin-6 (IL-6), interleukin-1 (IL-1), tumor necrosis factor TNF-a, and other mediators. These cytokines and mediators reach the liver, stimulating the synthesis of CRP by liver cells and epithelial cells. The concentration of CRP sharply increases within hours, but as the tissues recover structurally and functionally during the disease recovery phase, its levels rapidly decrease.


Therefore, CRP has significant clinical importance in the early diagnosis, progression, and prognosis of infections, inflammation, and other diseases.


Key Roles:


Elevated levels of CRP in the blood may indicate potential inflammatory conditions such as infections, autoimmune diseases, or cardiovascular diseases.


Main Applications:


Differential Diagnosis: Assisting in distinguishing between bacterial and viral infections.

Diagnosis of Inflammatory Diseases: Aiding in the diagnosis of inflammatory conditions like rheumatoid arthritis, lupus, and inflammatory bowel disease.

Treatment Monitoring: Monitoring the effectiveness of anti-inflammatory treatments.

Assessment of Cardiovascular Risk: Elevated CRP levels in the blood are associated with an increased risk of cardiovascular diseases, especially in patients with risk factors such as hypertension, diabetes, or high cholesterol.

Research: CRP testing is a crucial tool in biomedical research, particularly in studies related to inflammation and the immune system.

European Market Size of CRP Test Kits:


In 2020, the global market size for CRP test kits was approximately $21.8 billion, expected to grow to around $31.6 billion by 2028 with a compound annual growth rate (CAGR) of 4.9%.

The European market for CRP test kits accounted for a substantial portion of the global market, with an estimated size of around $1.32 billion in 2020, projected to grow to about $1.8 billion by 2028 with a CAGR of 4.1%.

Major Global Manufacturers of CRP Test Kits:

Roche Diagnostics (Switzerland)

Abbott Laboratories (USA)

Danaher Corporation (USA)

Thermo Fisher Scientific (USA)

Bio-Rad Laboratories (USA)

BioMerieux (France)

DiaSorin (Italy)

Sekisui Diagnostics (Japan)

Randox Laboratories (UK)

Snibe Diagnostic (China)

Boditech Med (South Korea)

Erba Mannheim (Germany/India)

Types of CRP Test Kits:


Conventional CRP Test Kits: Mainly used for evaluating infections, tissue damage, and inflammatory diseases.

High Sensitivity (hs) CRP Test Kits: Sensitive indicators for diagnosing low-level inflammatory states, also crucial in assessing the risk of cardiovascular diseases.

Full Range CRP Test Kits: Encompass both conventional and high-sensitivity CRP, suitable for diagnosing and monitoring infectious diseases and serving as an independent predictor for cardiovascular diseases.

Methods for Assessing Disease Severity:


Common methodologies include immunoturbidimetry, spectrophotometry, and immunochromatography.

CE-IVDR Certification Application for CRP Test Kits:


Classification rules include Class B, Rule 6, and Class C, Rule 4, depending on the intended use and whether it is for self-testing.

Clinical trial considerations involve clear inclusion and exclusion criteria, with a focus on patients with recent bacterial infections, suspected tissue damage, or various inflammatory diseases.

Substantial Equivalence and CE Marking:


Demonstrating substantial equivalence involves comprehensive comparative studies and providing substantial evidence of safety and efficacy, referencing existing CE-marked IVD devices.

Challenges include finding comparable devices, presenting detailed comparative study reports, and providing relevant evidence, such as literature, clinical trial data, and laboratory test results.


In summary, obtaining CE-IVDR certification for CRP test kits requires thorough comparative studies, detailed technical documentation, and substantial evidence of safety and efficacy. Manufacturers must carefully assess the feasibility of substantial equivalence evaluations and the necessity of clinical trials to ensure compliance with IVDR regulations.