ZEUS SCIENTIFIC, INC. A97101G AtheNA Multi-Lyte® HSV-1 & 2 IgG Plus Test System

The ZEUS AtheNA Multi-Lyte® Herpes Simplex Virus (HSV)-1 & 2 IgG Plus Test System is intended for the qualitative detection of presence or absence of IgG antibodies to HSV-1 and HSV-2 in human serum. The test is indicated for sexually active adults and expectant mothers, as an aid for presumptively diagnosing Herpes Simplex 1 and Herpes Simplex 2. The predictive value of positive or negative results depends on the population’s prevalence and the pretest likelihood of HSV-1 and HSV-2. The test is not intended for donor screening or for self testing. The performance of this assay has not been established for use in a pediatric population, neonates, immunocompromised patients, for use by point of care facilities or for use with automated equipment. This test is for In Vitro diagnostic use only.