Herpes simplex virus (HSV) (Human herpesvirus 1 & 2) IVDs

Intended purpose

The Aptima Herpes Simplex Viruses 1 & 2 assay (Aptima HSV 1 & 2 assay) is an in vitro real time nucleic acid amplification test (NAAT) for the qualitative detection and differentiation of messenger RNA (mRNA) from herpes simplex virus (HSV) type 1 (HSV-1) and type 2 (HSV-2) on the PantherTM system. The assay may be used to test clinician-collected swab specimens from skin lesions in the anogenital or oral region and placed in viral transport media (VTM) or Aptima specimen transport medium (STM). The assay will be used to aid in the diagnosis of HSV-1 and/or HSV-2 infections in symptomatic male and female patients. The device is not intended for use with cerebrospinal fluid or for prenatal screening.