MESACUP-3 TEST Jo-1

IVD-In Vitro Diagnostic Use CE marked

Instructions for use

The MESACUP-3 TEST Jo-1 is semi-quantitative enzyme-linked immunosorbent assay (ELISA) for the detection of anti-Jo-1 antibodies in human serum.

Background:

Anti-Jo-1 antibodies were first reported by Nishikai et al, and known to be detected in the serum from the patients with Polymyositis (PM) and Dermatomyositis (DM). Anti-Jo-1 antibodies are one of the anti-ENA antibodies and the corresponding antigen appeared to be histidyl-tRNA synthetase. Polymyositis and Dermatomyositis are considered to be the typical diseases, which result in, inflammatory myopathies and immunologic abnormalities have been implicated in the pathogenesis of these disorders, but details have not been revealed. Since this antibody was found in 20-30% patients with PM/DM and in 30-40% patients with PM, particularly in more than 60% patients with PM combined with interstitial lung disease and rarely found in the other collagen diseases, it is regarded as a marker for PM/DM. In recent studies, it was reported that the quantity of this antibody varied in proportion to disease activity. That is why anti-Jo-1 antibodies are also expected to indicate an effect of treatment.

The MESACUP-3 TEST Jo-1 is for measuring specifically with high sensitivity, anti-Jo-1 antibodies present in the serum by ELISA.

Principle:

The MESACUP-3 TEST Jo-1 measures anti-Jo-1 antibodies present in the serum by ELISA. Calibrators and patient serum are added to microwell coated with Jo-1 antigens, allowing anti-Jo-1 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