MESACUP-3 TEST Scl-70

IVD-In Vitro Diagnostic Use CE marked

Instructions for use

The MESACUP-3 TEST Scl-70 is semi-quantitative enzyme-linked immunosorbent assay (ELISA) for the detection of anti-Scl-70 antibodies in human serum.

Background:

Scl-70 antibodies are ENA antibodies present in high specificity in the sera of patients with Progressive Systemic Sclerosis (PSS). The antigen of anti-Scl-70 is identified with topoisomerase I, one of the nuclear enzymes, thus Scl-70 antibodies are also called topoisomerase I antibodies. Scl-70 antibodies, as well as centromere antibodies, in the sera of patients are essential for diagnosis of PSS. PSS is classified as two types; diffuse scleroderma and limited scleroderma. Scl-70 antibodies are present specifically in diffuse scleroderma and centromere antibodies are present in limited scleroderma. Therefore, detection of both antibodies is useful for classification of PSS. Rarely, Scl-70 antibodies are found in SLE and MCTD patients.

The MESACUP-3 TEST Scl-70 is for measuring specifically with high sensitivity, anti-Scl-70 antibodies present in the serum by ELISA.

Principle:

The MESACUP-3 TEST Scl-70 measures anti-Scl-70 antibodies present in the serum by ELISA. Calibrators and patient serum are added to microwell coated with Scl-70 antigens, allowing anti-Scl-70 antibodies to react with the immobilized antigen (Sample incubation). After wash to remove any unbound serum proteins, horseradish peroxidase conjugated anti human IgG, IgM and IgA 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