CertificateGMPSFDAISO13485ISO9001:2008
SUMMARY AND EXPLANATION OF THE TEST for HSV-2
HSV-2 causes mostly gennital and neonatal infections (1, 2) however, the tissue specificity are not absolute (3). Infants infected with HSV appear normal at birth but almost invariably develop symptoms during the newborn period (1, 4, and 5). Neonatal HSV infection may remain localized or become disseminated. Localized infection may involve one or a combination of sites. These are skin, eyes, mouth or central nervous system. Disseminated infection is manifested by pneumonitis, hepatitis, dissembinated intravascular coagulopathy and encephalitis. Of the infants with neonatal HSV, about one half of the serviving infants will develop severe neurological or ocular sequelae.
A number of serological procedures have been developed to detect antibodies to HSV. These include complement fixation, indirect immuneflorescent antibody, plaque neutralization, and ELISA (2, 4, and 6). Antibody of the IgM class is produced during the first 2-3 weeks of infection with HSV and exists only transiently
In most patientsSerologicprocedures which measure the presence of IgM antibodies help discriminate between primary and recurrent infections since IgM antibodies is rarely found in recurrent infections.
High affinity IgG antibodies to HSV, if presence in a sample, may interfere with the detection of IgM specific antibody (9). if present along with antigen specific IgG, may bind to IgG causing false positive IgM results. Both the problem can be eliminated by deactivating igG in the sample before testing for IgM.
Principles of the Tests
The quick one-step test utilizes a sandwich immunoassay system and the immunochromatographic detection assay, to be performed in one assay. If TORCH antibody is present in the sample in concentration above the detection, a labeled antibody-dye complex will be formed. This complex is then captured by antigen immobilized in the Test Zone (“T”) of the membrane, producing a visible pink-rose color band on the membrane. The color intensity will depend on the concentration of TORCH antibody in the sample. On the other hand, a color band will always appear at the control zone (“C”).