CCP Rapid Quantitative Test (Fluorescence Immunoassay)

The Biotime CCP Rapid Quantitative Test is intended to quantify the concentration of CCP in human serum, plasma and whole blood on Biotime FIA Analyzer by fluorescent immunoassay. The test is used as an aid detection of rheumatoid arthritis.

-Fluorescence immunoassay

-Rheumatoid arthritis

For in vitro diagnostic use only. For professional use only.

Specification

Clinical Significance:

Highly specific serological marker for Rheumatoid Arthritis (RA)

Enables early diagnosis of RA, often before clinical symptoms fully manifest

Predicts disease progression and joint destruction

Key Points:

Specificity: ~95–98% for RA → rarely positive in other autoimmune diseases or healthy individuals

Sensitivity: ~70–80% for established RA

Positive anti-CCP indicates poorer prognosis:

Higher radiographic scores

More deformed joints

More severe disease course

Can be detected years before the clinical onset of RA

Included in the 2010 ACR/EULAR classification criteria for RA