MESACUP-2 TEST SS-A

IVD-In Vitro Diagnostic Use CE marked

Instructions for use

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

Background:

SSA antibodies are ENA antibodies present in high frequency (88-96%) in the sera of patients with Sjögren’s Syndrome (SS) and SLE (24-60%). SSA antibodies are also sometimes found in patients with Rheumatoid Arthritis, Myositis and Scleroderma. SSB antibodies are ENA antibodies present in high frequency (71-87%) in Sjögren’s Syndrome and in lower frequency in SLE (9-35%). It has been confirmed that the SSA and SSB antibodies are identical with anti-Ro and anti-La respectively. SSB antibodies are frequently associated with SSA antibodies and are rarely detected alone. SSB antibodies are seen almost exclusively in women; and, the presence of both SSA and SSB antibodies in mothers and infants are associated with skin lesions, neonatal lupus and congenital heart block.

The MESACUP-2 TEST SS-A is for measuring specifically with high sensitivity, anti-SS-A/Ro antibodies present in the serum by ELISA.

Principle:

The MESACUP-2 TEST SS-A measures anti-SS-A/Ro antibodies present in the serum by ELISA. Calibrators and patient serum are added to microwell coated with SS-A antigens, allowing anti-SS-A/Ro 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