A rapid test for the qualitative detection of IgG and IgM antibodies to HSV 1/2 in human whole blood, serum or plasma.
For professional in vitro diagnostic use only.
INTENDED USE
The HSV 1/2 IgG/IgM Rapid Test Cassette is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to HSV 1/2 in whole blood, serum or plasma to aid in the diagnosis of HSV 1/2 infection.
SUMMARY
Herpes simplex virus 1 and 2 (HSV-1 and HSV-2), also known as human herpesvirus 1 and 2 (HHV-1 and HHV-2), are two members of the herpesvirus family, Herpesviridae, that infect humans.¹ Both HSV-1 (which produces most cold sores) and HSV-2 (which produces most genital herpes) are ubiquitous and contagious. They can be spread when an infected person is producing and shedding the virus.
In simple terms, herpes simplex 1 is most commonly known as a "cold sore," while herpes simplex 2 is the one known by the public as "herpes," or "genital herpes." According to the World Health Organization, 67% of the world population under the age of 50 have HSV-1.²
Symptoms of herpes simplex virus infection include watery blisters in the skin or mucous membranes of the mouth, lips, nose or genitals.¹ Lesions heal with a scab characteristic of herpetic disease. Sometimes, the viruses cause very mild or atypical symptoms during outbreaks. However, they can also cause more troublesome forms of herpes simplex.
As neurotropic and neuroinvasive viruses, HSV-1 and -2 persist in the body by becoming latent and hiding from the immune system in the cell bodies of neurons. After the initial or primary infection, some infected people experience sporadic episodes of viral reactivation or outbreaks. In an outbreak, the virus in a nerve cell becomes active and is transported via the neuron's axon to the skin, where virus replication and shedding occur and cause new sores.³ It is one of the most common sexually transmitted infections.⁴
The detection of anti-HSV 1/2 IgG/IgM antibody enables effective diagnosis of acute or recent HSV 1/2 infection. The HSV 1/2 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to HSV 1/2 in whole blood, serum or plasma specimens.
