Herpes Simplex Virus (HSV) is responsible for several clinically significant human viral diseases, with severity ranging from mild to fatal. Herpes Simplex Virus Type 1 infection are usually found above the waist. Herpes Simplex Virus Type 2 infections are more commonly seen in association with the genitalia, and surrounding areas, and are usually sexually transmitted. It is important to note however, that both Herpes Simplex types 1 and 2 have been involved in all disease manifestations and locations of the body, following introduction of the virus through broken skin or mucous membranes.

The SureSwab®, HSV Type 1/2 mRNA, TMA assay is intended for use as an aid in the diagnosis of HSV-1 and/or HSV-2 infections in symptomatic male and female patients. The assay is not validated for cerebral spinal fluid samples or for use in prenatal screening.

Herpes Simplex Virus (HSV) is responsible for several clinically significant human viral diseases, with severity ranging from inapparent to fatal. Clinical manifestations include genital tract infections, neonatal herpes, meningoencephalitis, keratoconjunctivitis, and gingivostomatitis. There are two HSV serotypes that are closely related antigenically. HSV type 2 is more commonly associated with genital tract and neonatal infections, while HSV type 1 is more commonly associated with infections of non-genital sites. Specific typing is not usually required for diagnosis or treatment. The mean time to seroconversion using the type specific assay is 25 days. The performance of this assay has not been established for use in a pediatric population, for neonatal screening, or for testing of immunocompromised patients.