INTENDED USE

The HSV-1 IgG/IgM Rapid Test Cassette is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to HSV-1 in whole blood, serum or plasma to aid in the diagnosis of HSV-1 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. Both HSV-1 (which produces mostcold 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.
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. It is one of the most common sexually transmitted infections.
The detection of anti-HSV-1 IgG/IgM antibody enable effective diagnosis of acute or recent HSV-1 infection. The HSV-1 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 in whole blood, serum or plasma specimens.

PRINCIPLES

The HSV-1 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative, lateral flow immunoassay for the detection of IgG and IgM antibodies to HSV-1 in whole blood, serum or plasma specimens. In this test, mouse anti-human IgGand goat anti-human IgM is coated in the test line regions of the test. During testing, the whole blood, serum or plasma specimen reacts with HSV-1 antigen coated particles in the test strip. The mixture then migrates forward on the membrane by capillary action and reacts with the mouse anti-human IgG or goat anti-human IgM on the membrane in the test line region respectively. The presence of a colored line in the test line region indicates a positive result for HSV-1 infection, while its absence indicates a negative result for that infection.
To serve as a procedural control, a colored line will always appear in the respective control line region of the strip indicating that proper volume of specimen has been added and membrane wicking has occurred.