Lomina HPV Antibody – Human Papillomavirus blood test – in development
Intended Use:
The LOMINA HPV Antibody Rapid Test is a lateral flow immunoassay for the detection of specific IgG antibodies to human papillomavirus (HPV) in a human detecting the presence of specific IgG antibodies to HPV16 and HPV18.
HPV IgG Test:
Human papillomavirus infection (HPV infection) is an infection by human papillomavirus (HPV). Most HPV infections cause no symptoms and resolve spontaneously. HPV types 16 and 18 are the most common oncogenic HPV types, responsible for about 70% of all cervical cancers. An HPV infection is caused by human papillomavirus, a DNA virus from the papillomavirus family, of which over 170 types are known. These types are typically spread by sustained direct skin-to-skin contact, with vaginal and anal sex being the most common methods. Occasionally, it can spread from a mother to her baby during pregnancy. People can become infected with more than one type ofHPV.7 HPV affects only humans.
Since 2007, HPV vaccination has been widely available in developed countries as well as in some developing countries. Vaccines to prevent HPV infection have the potential to drastically reduce the global burden of cervical cancer. Three U.S. Food and Drug-Administration approved HPV vaccines, Cervarix, Gardasil, and Gardasil-9, are commercially available to protect against HPV16 and HPV18. Earlier studies have shown that Cervarix and Gardasil vaccine induce persistently high levels of neutralizing antibodies against HPV antigen, especially IgG and IgA. The presence of HPV IgG antibodies in human whole blood, serum or plasma may indicate the HPV immunization status. The HPV IgG Rapid Test uses HPV16 and HPVl 8 antigens to detect IgG antibodies to human papillomavirus.
Available Packaging Variants:
Usable Biological Material:
The test is developed and tested for the use of serum, plasma and whole blood samples.
Whole blood
Serum
Plasma
Major Parameters, Characteristics & Limits
Test duration: 15 min
IVD category: IVD other
Disease category: Infectious Disease (early Tumor indicator)
Principle:
The LOMINA HPV Antibody Rapid Test Device detects specific IgG antibodies for human papillomavirus through visual interpretation of color development on the internal strip. Anti-human IgG antibodies are immobilized on the test regions of the membrane. HPV16 and HPV18 antigens conjugated with colored particles (HPV conjugates).
When specimen and then buffer is added to the sample well on the test panel, specific IgG antibodies, if present, will bind to the HPV conjugates on the sample pad. As the specimen migrates along the strip by capillary action and interacts with reagents on the membrane, the complex will be captured by anti-human IgG antibodies immobilized at the detection zone. Colored bind will form at the test region. The presence of colored band(s) indicates a positive result, while its absence indicates a negative result.
As liquid continues to migrate down the test strip, the control line appears. The appearance of this colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
