(73 days)
The Epstein Barr Nuclear Antigen 1 (EBNA-1) IgM kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative determination of IgM antibodies in human serum to EBNA-1 antigen. The Clark anti-EBNA-1 IgM assay may be used in conjunction with other Epstein-Barr serologies (VCA IgG, VCA IgM, EA-D IgG, EBNA-1 IgG and heterophile) as an aid in the diagnosis of infectious mononucleosis in adult populations.
The Wampole Epstein-Barr Virus Nuclear Antigen 1 (EBNA-1) IgM kit is an Enzyme-Linked Immunosorbent Assays (ELISA) for the qualitative determination of IgM antibodies in human serum to EBNA-1 antigen. The Wampole anti-EBNA-1 IgM assay may be used in conjunction with other Epstein-Barr serologies (VCA IgG, VCA IgM, EA-D IgG, EBNA-1 IgG and heterophile) as an aid in the diagnosis of infectious mononucleosis.
For In Vitro Diagnostic Use Only.
The EBNA-1 IgM ELISA test is an enzyme linked immunosorbent assay to detect IgM antibodies to Epstein-Barr Nuclear Antigen -1. Recombinant EBNA-1 antigen is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgM is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.
Here's an analysis of the provided information regarding the EBNA-1 IgM ELISA Test Kit, presented with the requested structure:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in the provided text. However, based on the presented performance characteristics, we can infer the implied targets for sensitivity and specificity. The study demonstrates performance against these inferred criteria.
| Performance Metric | Implied Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Sensitivity | High for acute cases (target > ~50%) | 51.4% (95% CI: 34.9%-67.8%) |
| Specificity (Seronegative) | High (target = 100%) | 100% (95% CI: 89.4%-100%) |
| Specificity (Seropositive) | High (target > ~90%) | 94.5% (95% CI: 89.7%-99.3%) |
| Relative Agreement | High (target > ~80%) | 85.3% (95% CI: 79.6%-90.9%) |
| Precision (Inter-Site CV) | Low variability (e.g., |
§ 866.3235 Epstein-Barr virus serological reagents.
(a)
Identification. Epstein-Barr virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Epstein-Barr virus in serum. The identification aids in the diagnosis of Epstein-Barr virus infections and provides epidemiological information on diseases caused by these viruses. Epstein-Barr viruses are thought to cause infectious mononucleosis and have been associated with Burkitt's lymphoma (a tumor of the jaw in African children and young adults) and postnasal carcinoma (cancer).(b)
Classification. Class I (general controls).