The Onco-HPV reagent kit is designed for the qualitative detection of high-risk human papillomavirus (HPV) DNA in human biomaterial samples and their differentiation using polymerase chain reaction (PCR) with real-time fluorescence detection.
Smears from the urogenital tract (cervical canal epithelial scrapings, cervical epithelial scrapings, and urethral epithelial scrapings) are used for testing. This reagent kit can detect HPV DNA of the following types: 16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, and 73. These HPV types exhibit high transforming activity against epithelial cells and may be an etiologic factor in the development of cervical dysplasia and cervical cancer.
The kit is intended for clinical laboratory diagnostics and scientific research.
For in vitro testing only.
Diagnosis of Human Papillomavirus Infection (HPV)
HPV is caused by human papillomaviruses (HPV), which affect the skin and mucous membranes, causing foci of chronic inflammation. The infection manifests as characteristic bumps and growths on the skin. HPV is a large, diverse group of viruses, comprising over 200 types, varying in pathogenicity and ability to cause malignant transformation of epithelial cells.
According to their transforming activity, HPV is typically classified as high-risk and low-risk. High-risk HPV types include: 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, and 82. High-risk HPV can cause cervical cancer and malignant tumors of the anogenital region.
According to statistics, approximately 70% of cervical cancer cases are associated with the presence of HPV types 16 or 18.
Types 6, 11, 40, 42, 43, 44, 46, 54, 61, and 70 are classified as low-risk human papillomaviruses. Some types of human papillomavirus (including types 1-4, 10, 28, and 49) cause cosmetic problems by causing warts on various areas of the skin, but these types of papillomas pose no health risk. Accurate differentiation of the virus type and determination of whether it is high- or low-risk HPV is essential for timely and appropriate treatment. Importantly, only chronic human papillomavirus infection, caused by viruses with high transforming activity, can lead to severe consequences.
PCR is a highly sensitive and specific laboratory diagnostic method for human papillomavirus infection. The test material consists of swabs from the urogenital tract (cervical canal epithelial scrapings, cervical epithelial scrapings, and urethral epithelial scrapings).
When testing for HPV DNA, it is crucial to follow the rules for collecting the biological material. Since HPV is intracellular, the swabs must contain a sufficient number of epithelial cells. All test systems designed to diagnose human papillomavirus infection provide the ability to control the collection of biological material; in quantitative tests, the HPV DNA concentration is calculated.
The threshold for transforming activity is considered to be a high-oncogenic risk HPV DNA concentration of 10^5 GE in the scraping or 10^3 GE per 10^5 human epithelial cells.
