Enzyme Immuno Assay (ELISA) for the determination of IgM class antibodies to Cytomegalovirus or CMV in human plasma and sera with the “capture” system. The kit is intended for the follow-up of CMV infected patients and the monitoring of the risk of neonatal defects due to CMV infection during pregnancy. For “in vitro” diagnostic use only.
The assay is based on the principle of “IgM capture” where IgM class antibodies in the sample are first captured by the solid phase coated with anti hIgM antibody.
After washing out all the other components of the sample and in particular IgG antibodies, in the 2nd incubation bound anti CMV IgM are detected by the addition of a complex composed of native CMV antigens and CMV specific monoclonal antibodies, labeled with peroxidase (HRP).
After incubation, microwells are washed to remove unbound conjugate and then the chromogen/substrate is added. In the presence of bound conjugate the colorless substrate is hydrolyzed to a colored end-product, whose optical density may be detected and is proportional to the amount of IgM antibodies to Cytomegalovirus present in the sample.
A system is described how to control whether the positivity shown by a sample is true or not (Confirmation Test), helpful for the clinician to make a correct interpretation of results.