Description

Anti-CCP Test Kit (25 Tests) – Immunofluorescence Assay

Product Overview
The Anti-CCP Test Kit is a fluorescence immunoassay designed for quantitative determination of Anti‑Cyclic Citrullinated Peptide (Anti‑CCP) antibodies in human serum, plasma or whole blood samples. Anti‑CCP antibodies are highly specific biomarkers associated with rheumatoid arthritis and autoimmune inflammatory disorders.

Intended Use
The Anti‑CCP Fast Test Kit is intended for in vitro quantitative determination of Anti‑CCP antibodies in human serum, plasma or whole blood samples. The test is used as an aid in diagnosis of rheumatoid arthritis and differentiation of inflammatory joint diseases.

Clinical Significance
Anti‑CCP antibodies are autoantibodies directed against citrullinated proteins and are highly specific markers for rheumatoid arthritis. Measurement of Anti‑CCP levels helps clinicians diagnose rheumatoid arthritis at an early stage, differentiate rheumatoid arthritis from other joint diseases, assess disease progression and monitor treatment response.

Test Principle
The test uses fluorescence‑labelled CCP antigen and anti‑human IgG antibodies coated on the test strip. Anti‑CCP antibodies in the sample bind with labelled antigen forming complexes which are captured on the membrane. The fluorescence signal measured by the analyzer is proportional to Anti‑CCP concentration.

Sample Type
Serum, Plasma, Whole Blood

Sample Volume
10 µL

Test Time
Approximately 15 minutes

Measuring Range
10.0 – 400.0 U/mL

Technology
Fluorescence Immunoassay

Compatible Analyzers
GETEIN 1100 Immunofluorescence Quantitative Analyzer
GETEIN 1160 Immunofluorescence Quantitative Analyzer

Storage and Stability
Store at 4–30°C. Shelf life 24 months. Use test card within 1 hour after opening foil pouch.

Applications
Suitable for rheumatology testing, autoimmune disease diagnosis, hospital laboratories and diagnostic centers.