Intended Use
For the qualitative determination of IgM antibodies to Epstein-Barr Virus (recombinant) Early Antigen Diffuse (EBV-EA-D IgM) in human serum by indirect enzyme immunoassay. The Diamedix immunosimplicity (Is®) EBV-EA-D IgM Test Kit may be used in combination with other Epstein-Barr serologies, Viral Capsid Antigen (VCA) IgG and IgM, Epstein-Barr Nuclear Antigen-1 (EBNA-1) IgG and IgM, Early Antigen-Diffuse (EA-D) IgG and heterophile antibody as an aid in the diagnosis of infectious mononucleosis (IM). The test can be performed either manually or in conjunction with Mago® Plus automated systems.
For In Vitro Diagnostic Use.
Summary
Epstein-Barr virus (EBV) is a member of the herpesvirus family that infects human lymphocytes. It is known to cause infectious mononucleosis (IM) and is transmitted primarily by saliva.
Humoral response to primary EBV infection appears to be quite rapid. Antibodies to EBV are made to various viral proteins, with specific antibodies correlating to disease state. In acute infection IgM and then IgG antibodies are sequentially made to early antigen-diffuse (EA-D), viral capsid antigen (VCA), and nuclear antigen. Current or recent infection is marked by the presence of IgM antibodies to EA-D, VCA, and EBNA. IgG antibodies to EA-D and VCA are normally present in current infection, while IgG antibodies to EBNA are absent. Post EBV infection is indicated by sustaining IgG antibody to VCA and EBNA and the absence of IgM antibodies. Thus, the monitoring of EBV antibody patterns may assist in the diagnosis of EBV infection since individual levels of specific antibodies may not necessarily be indicative of disease, but can be of diagnostic importance when monitored as a profile.
Principle of the Procedure
Recombinant EA-D antigen is bound to microwells. Diluted patient sera, Cut-Off Calibrator and controls are placed in the microwells and incubated. Anti-EA-D IgM antibodies, if present, will bind to the antigen forming antigen-antibody complexes. Residual sample is eliminated by aspirating and washing. Conjugate (horseradish peroxidase-labeled anti-human IgM) is added and will bind to these complexes. Unbound conjugate is removed by aspiration and washing. Substrate is then added and incubated. In the presence of bound enzyme the substrate is converted to an end product. The absorbance of this end product can be read spectrophotometrically at 450 nm (reference 600-630 nm) and is a measurement of IgM antibodies to EA-D present in the sample.
Please refer to complete Package Insert for greater detail about the test.
Features & Benefits
Formatted Procedures
