(145 days)
The Herpes Group IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for qualitative determination of IgG antibodies in human serum to Herpes simplex virus. The Herpes Group IgG ELISA kit may be used to evaluate paired sera for the presence seroconversions of IgG as an aid in the diagnosis of Herpes simplex virus infection.
The Herpes Group IgG ELISA test is an enzyme linked immunosorbent assay to detect IgG antibodies to Herpes simplex virus. Purified Herpes Group 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 acceptance criteria and study proving the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Relative Sensitivity (compared to Clark HSV 1 & HSV 2 ELISA) | Overall: 98.9% (95% CI: 97.9% - 100%) |
| Site 1: 99.1% | |
| Site 2: 97.9% | |
| Site 3: 99.1% | |
| Site 4: 100.0% | |
| Relative Specificity (compared to Clark HSV 1 & HSV 2 ELISA) | Overall: 96.7% (95% CI: 94.2% - 99.1%) |
| Site 1: 94.7% | |
| Site 2: 100% | |
| Site 3: 94.7% | |
| Site 4: 96.2% | |
| Relative Agreement (compared to Clark HSV 1 & HSV 2 ELISA) | Overall: 98.1% (95% CI: 97.0% - 99.2%) |
| Site 1: 97.2% | |
| Site 2: 98.6% | |
| Site 3: 97.7% | |
| Site 4: 98.9% | |
| Precision (Inter-site, %CV) | **Generally |
§ 866.3305 Herpes simplex virus serological assays.
(a)
Identification. Herpes simplex virus serological assays are devices that consist of antigens and antisera used in various serological tests to identify antibodies to herpes simplex virus in serum. Additionally, some of the assays consist of herpes simplex virus antisera conjugated with a fluorescent dye (immunofluorescent assays) used to identify herpes simplex virus directly from clinical specimens or tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by herpes simplex viruses and provides epidemiological information on these diseases. Herpes simplex viral infections range from common and mild lesions of the skin and mucous membranes to a severe form of encephalitis (inflammation of the brain). Neonatal herpes virus infections range from a mild infection to a severe generalized disease with a fatal outcome.(b)
Classification. Class II (special controls). The device is classified as class II (special controls). The special control for the device is FDA's revised guidance document entitled “Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.” For availability of the guidance revised document, see § 866.1(e).