Device Dossier
Herpes simplex virus (HSV) (Human herpesvirus 1 & 2) IVDs
Device Dossier for Herpes simplex virus (HSV) (Human herpesvirus 1 & 2) IVDs (CT749 - Herpes simplex virus (HSV) (Human herpesvirus 1 & 2) IVDs, Class 3,…
Intended purpose
A multiplex flow immunoassay intended for the qualitative detection of and differentiation of IgG antibodies to herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) in human serum and EDTA or heparinized plasma. The test is indicated for sexually active individuals and expectant mothers as an aid for the presumptive diagnosis of HSV-1 or HSV-2 infection. The predictive value of positive or negative results depends on the population’s prevalence and the pretest likelihood of HSV-1nd HSV-2.