Intended Use
The Human anti- HPV16L1 IgG ELISA Kit is an immunoassay suitable for detecting and quantifying IgG antibody activity specific for Human Papilloma Virus, subtype 16 L1 protein, in serum or plasma. Other biological fluids, including tissue culture medium, may be validated for use. For research use only (RUO).
Storage
The microtiter well plate and all other reagents, if unopened, are stable at 2-8°C until the expiration date printed on the box label.
General Description
Human papillomavirus (HPV) causes cervical cancer, the third most common cancer in women worldwide. Lifetime incidence of HPV infection is estimated to be 80%. Like all papillomaviruses, HPVs establish productive infections only in keratinocytes of the skin or mucous membranes. Most infections become undetectable within 1–2 years and only a small fraction of infections with high-risk HPV fail to clear, resulting in overt HPV persistence. Over 120 HPV types have been identified and are referred to by number; types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, and 59 are "high-risk" sexually transmitted HPVs. Neutralizing antibodies are expected to be the primary immune mechanism for protection against infection.
Two vaccines are available to prevent infection by some HPV types: Gardasil, marketed by Merck, and Cervarix, marketed by GlaxoSmithKline. Both vaccines utilize recombinant L1 proteins and protect against initial infection with HPV types 16 and 18, which cause most of the HPV associated cancer cases. Creative Diagnostics has cloned, expressed, and purified full length HPVL1 proteins (HPV6, 11, 16, and 18) and used them to develop ELISA to measure antibodies against HPVL1 proteins. These kits will be useful for studying efficacy of existing vaccines and preparations of more effective HPV vaccines formulations.
COA
Publication 
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