MESACUP-2 TEST RNP

IVD-In Vitro Diagnostic Use CE marked

Instructions for use

The MESACUP-2 TEST RNP is semi-quantitative enzyme-linked immunosorbent assay (ELISA) for the detection of anti-RNP antibodies in human serum.

Background:

RNP antibodies are ENA (extractable nuclear antigen) antibodies, present with high frequency in the sera of patients with collagen diseases such as SLE and mixed connective tissue disease (MCTD). Mixed connective tissue disease is a clinical disease combining features of SLE, Progressive Systemic Sclerosis (PSS) and Polymyositis/Dermatomyositis (PM/DM). The presence of RNP antibodies in the sera of patients is essential for diagnosis of MCTD. RNP antibodies, when present alone at high levels, are diagnostic of MCTD. Lower levels of anti-RNP, in conjunction with other autoantibodies may be observed in PSS, Sjögren’s Syndrome (SS) and Rheumatoid Arthritis (RA).

Among the methodologies available to detect anti-ENA's are Immunoblot, Double Immunodiffusion (DID), Immunoprecipitation (IPP) and Enzyme-linked Immunosorbent Assay (ELISA). The ELISA tests are specific, sensitive, and due to their objectivity and rapidity, suitable for testing samples from patients with suspected connective tissue diseases. The MESACUP-2 TEST RNP uses recombinant protein for the solid phase antigen. Therefore, the test shows specificity for detection of anti RNP antibodies present in high frequency in the sera of patients with certain connective tissue diseases.

Principle:

The MESACUP-2 TEST RNP measures anti-RNP antibodies present in the serum by ELISA. Calibrators and patient serum are added to microwell coated with RNP antigens, allowing anti-RNP antibodies to react with the immobilized antigen (Sample incubation). After wash to remove any unbound serum proteins, horseradish peroxidase conjugated anti human IgG, IgA and IgM are added and incubated (Conjugate incubation). Following another washing step, the peroxidase substrate is added and incubated for an additional period of time (Substrate incubation). Acid solution is then added to each well to terminate the enzyme reaction and to stabilize the color development. The assay can be quantified by measuring the reaction photometrically and plotting the results.

Size: 96 wells

Method: ELISA

Antigen: recombinant purified proteins

Availability: all regions