The Anti-HSV gG-1 IgG is intended for the qualitative detection of type specific IgG class antibodies to Herpes Simplex Virus Type 1 (HSV-1) in human serum. The test is intended for testing sexually active individuals or pregnant women for aiding in the presumptive diagnosis of HSV-1 infection. The predictive value of positive or negative results depends on the population’s prevalence and the pretest likelihood of HSV-1. The test is not intended for donor screening or for self testing. The performance of this test has not been established for use in a pediatric population, neonates, children, or immuno-compromised patients.
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to herpes simplex virus 1 (HSV1) in a clinical specimen, using an enzyme immunoassay (EIA) method.