MESACUP-2 TEST CENP-B

IVD-In Vitro Diagnostic Use CE marked

Instructions for use

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

Background:

Anti-centromere antibodies (ACA) are first reported in 1980 by Moroi et. al., and known to be detected in the serum from the patients with the CREST syndrome of scleroderma and PBC. Earnshaw et. al., designated the antigens which are recognized by ACA CENP (Centromere Protein) -A (17 kDa), CENP-B (80 kDa) and CENP-C (140 kDa) according to the molecular weight. They also identified four different epitopes in the CENP-B antigens from the study with affinity eluted antibodies. In 1987, they cloned the CENP-B cDNA and clarified three independent epitopes on CENP-B that were targets of auto-antibodies. Further more, they established ELISA using a cloned fusion protein, c-term CENP-B, as antigen. The fusion protein included the c-terminal 147 amino acids carried the major epitope of CENP-B. Therefore, that ELISA had much higher sensitivity and specificity than immunofluorescence in the detection of ACA.

The MESACUP-2 TEST CENP-B is for measuring specifically with high sensitivity, anti-CENP-B antibodies present in the serum by ELISA.

Principle:

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