Medizym® anti-CCP Ref

Rheumatoid Arthritis (RA) is a chronic, systemic autoimmune disease, characterized by progressive deterioration of joints and high therapeutic follow-up costs. It affects about 1 percent of the world’s population. The clinical diagnosis consists of clinical findings, imaging techniques as well as serological laboratory tests.

In addition to the determination of inflammatory parameters and rheumatoid factors, the detection of antibodies against cyclic citrullinated peptides (CCP) plays a significant role. Medizym® anti-CCP Ref is a highly specific ELISA for the determination of IgG autoantibodies against CCP in human serum or plasma.

CCP antibodies show a considerably higher diagnostic sensitivity and specificity compared to rheumatoid factor.

  • CCP antibodies are detectable long before the onset of the disease (early marker)
  • CCP antibodies possess a highly predictive value for the prognostic assessment of disease progression.

Medizym® anti-CCP Ref is an enzyme immunoassay for the quantitative and semi-quantitative determination of IgG autoantibodies against CCP in human serum or plasma. Using a cut-off of ≥ 30 U/ml, Medizym® anti-CCP Ref has a diagnostic sensitivity of 79 percent for patients with manifested RA and a diagnostic specificity of 97 percent. The analytical assay sensitivity is 2 U/ml.

Assay principle

Enzyme immunoassay, ELISA

Assay size

96 determinations

Indication

Rheumatoid Arthritis

Parameter

IgG antibodies against CCP (cyclic citrullinated peptides)

Preparation

Dilution of patient samples 1:100 with sample diluent, standards and controls are ready to use

Result

Quantitative: U/ml Cut-off: ≥ 30 U/ml, Semi-quantitative: Binding index (BI), Cut-off: ≥ 1

Incubation time

60 min RT - 30 min RT - 15 min RT in the dark

Substrate

Tetramethylbenzidine (TMB), 450 nm

Sample material

human serum or plasma

Using the Medizym® anti-CCP Ref 96 determinations can be carried out within 105 minutes, which can be analyzed quantitatively as well as semi- quantitatively with a photometer for microtiter plates. The kit is designed for manual as well as automatic processing using ELISA automates.

Egerer K., Feist, E. & Burmester, G.R. The serological diagnosis of rheumatoid arthritis: antibodies to citrullinated antigens. Dtsch Arztebl Int. 2009; 106(10): 159-163.

 

Gross, W.L., Moosig, F. & Lamprecht, P. Anticitrullinated protein/peptide antibodies in rheumatoid arthritis. Dtsch Ärztebl Int. 2009; 106(10): 157-158.