Kızamıkçık (Rubella) IgM EIA Capture Kiti

Intended Use:

Enzyme Immunoassay (EIA) for the detection of human IgM antibodies to Rubella virus in serum, plasma and oral fluid specimens. This product is for research use only and for use by trained laboratory personnel.

Test Principle

In the Microimmune Rubella IgM capture EIA, undiluted oral fluid extracted from a collection device (e.g. "Oracol" or "OraSureâ") or diluted serum / plasma is added to anti-human IgM coated microtitre wells in duplicate. IgM in the specimen binds to the wells and after washing, recombinant Rubella Antigen (rRA) is added to one of the duplicate sample wells and diluent to the other well. Rubella specific IgM in the sample, if present, binds the rRA. After washing the wells a monoclonal antibody to the rRA conjugated to horseradish peroxidase is added. After washing, tetramethylbenzidine (TMB) substrate is added to reveal the presence of specific IgM. The presence of Rubella specific IgM results in a colour change in the TMB from colourless to blue which then changes to yellow on stopping the reaction with 0.5M HCl. The colour change and intensity are monitored using a spectrophotometric plate reader set at 450nm with a correction filter between 620 and 650nm. The presence of Rubella specific IgM is indicated by an increase in optical density above the cut-off value in the antigen well compared to the control well.

Features of the test include:

• Assay time: < <3.5 h
• No. of tests: Maximum of 48 tests per kit including two controls
• Specimen type: oral fluid, serum / plasma
• Reagents: Colour coded and mostly ready to use.
• Shelf life: 12 months at 2..8°C
• Performance: 96.9% sensitive (95%CI 98.2% to 99.96%) with a PPV of 100% (95% CI 94.2% to 100.0%) and 100% specificity (95% CI 93.2% to 100%) compared to competitor test on serum samples. 95.5% Sensitivity of 95.5% (95% CI 84.5 to 99.4) using Microimmune test on oral fluids compared to results on matched serum and blood spots using competitor test. For more information see