(218 days)
The . Epstein-Barr Early Antigen Diffuse component (EA-D) IgG kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative determination of IgG antibodies in human serum to EA-D antigen. The Clark anti-EA-D IgG assay may be used in conjunction with other Epstein-Barr serologies (VCA IgG, VCA IgM, EBNA-1 IgG, EBNA-1 IgM and heterophile) as an aid in the diagnosis of infectious mononucleosis. For In Vitro Diagnostic Use Only.
Epstein-Barr Early Antigen Diffuse component (EA-D) IgG kit is an Enzyme-Linked The Immunosorbent Assay (ELISA) for the qualitative determination of IgG antibodies in human serum to EA-D antigen. The Clark anti-EA-D IgG assay may be used in conjunction with other Epstein-Barr serologies (VCA IgG, VCA IgM, EBNA-1 IgG, EBNA-1 IgM and heterophile) as an aid in the diagnosis of infectious mononucleosis. The EA-D IgG ELISA test is an enzyme linked immunosorbent assay to detect IgG antibodies to Epstein-Barr Early Antigen Diffuse component. Purified recombinant EA-D 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 IgG 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 text to extract the acceptance criteria and study information:
Acceptance Criteria and Device Performance for EA-D IgG ELISA Test Kit
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied/Derived) | Reported Device Performance |
|---|---|---|
| Sensitivity (Late Acute) | High (e.g., >95%) | 100% (95% CI: 67.9%-100%) |
| Specificity (Seronegative) | High (e.g., >95%) | 100% (95% CI: 79.1%-100%) |
| Specificity (Early Acute) | High (e.g., >90%) | 97.0% (95% CI: 91.0%-100%) |
| Sensitivity (Seropositive) | Not explicitly defined as a target for "sensitivity" in this context, but rather an expected low positive rate. | 19.7% (95% CI: 12.8%-26.6%) |
| Specificity (Seropositive) | High (e.g., >70-80%) | 80.3% (95% CI: 73.4%-87.2%) |
| Overall Relative Agreement | High (e.g., >80%) | 85.6% (95% CI: 80.5%-90.8%) |
| Precision (Coefficient of Variation - CV) | Low (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).