REF:

C1313 (Cassette)

INTENDED PURPOSE:

NOVAtest® Herpes Simplex Virus Type-2 IgG/IgM Antibody Joint Test is an immunochromatographic assay that use immunocapture method for qualitative detection of anti-HSV-2 IgG/IgM antibodies from serum, plasma and whole blood specimens of human. It’s used as an aid in the diagnosis of the Herpes Simplex Virus Type-2 infection. This device is performed manually.

INTENDED USER:

Performance of the test is limited to laboratory professional use.

SUMMARY:

Genital herpes affects more than 400 million persons worldwide. The prevalence of both HSV types increased with age and was higher among women than men. There are 2 types of HSV: herpes simplex 1 (HSV-1) and herpes simplex 2 (HSV-2). Each type presents differently clinically and varies in severity. HSV-1 commonly causes herpes labialis, herpetic stomatitis, and keratitis. HSV-2 typically causes genitalherpes. HSV-2 is transmitted primarily by direct sexual contact with lesions.

Most HSV-1 infections occur in childhood, with the lifelong potential for symptomatic and asymptomatic viral shedding and in rare cases can lead to more serious complications, such as

encephalitis. Recurrent HSV-1 infections of the oral mucosa are uncommon in otherwise healthy patients. However, immunocompromised patients often experience recurrent, aggressive outbreaks. HSV-2 can increases the risk of human immunodeficiency virus (HIV) acquisition and causes neonatal herpes, which is transmitted during vaginal delivery through direct mucosal or skin contact. DNA test and serologic assays are useful for diagnosis of HSV infections.