REALQUALITY RQ-HPV Screen

Description

The REALQUALITY RQ-HPV Screen is an IVD for the qualitative detection of the DNA of 14 high risk (HR) oncogenic genotypes (HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 e 68) of the Human Papillomavirus (HPV) by Real time amplification (Real-Time PCR).

The REALQUALITY RQ-HPV Screen can be used:

• As primary screening test to identify the patient with a major risk of cervical carcinoma development or the presence of a high grade pathology, using extracted DNA from cytological samples in liquid phase.
• As auxiliary test for the diagnosis and monitoring of HPV infections, using extracted DNA from human clinical samples.

The kit is suitable for HPV screening, according to the Maeijer criteria

Product Characteristics

• The device is validated on DNA extracted from various samples types
• The assay requires only 5 µL of DNA extracted
• The kit allows the detection of 14 high risk oncogenic HPV genotypes (HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 e 68)
• The kit is able to specifically identify the HPV 16 and HPV 18 genotypes.
• The assay shares the same thermal profile of the REALQUALITY Infectious diseases kits and of the REALQUALITY HPV kits
• Validated on main Real time PCR instruments
• The assay includes dUTP/UNG system for preventing carry-over contamination and a fluorescence normalizer
• The automatic format of the assay can be used on GENEQUALITY® automatic platforms
• Easy interpretation of results with AB Genius Report software

Kit content

Kit content:

• Ready-to-use reagents for Real time PCR
• Positive control
• Internal control

Further Information

Human Papillomavirus (HPV) infection is the most common and widespread of sexually transmitted diseases. The different types of HPV are generally divided into low-risk and high-risk cancer risk genotypes. The latter (in particular HPV 16 and 18) are recognized as the necessary cause of cervical cancer and, in general, among the most important carcinogenic viruses for the human species. The transforming role, in fact, does not end in genesis of the cervical carcinoma, but it is strongly correlated to other neoplasms of the female and male genital sphere (vulva, vagina, anus, penis) and extragenital neoplasms (oral cavity, pharynx, larynx). The carcinogenic potentials can be ascribed to two viral oncoproteins (E6 and E7) which, after the integration of the viral genome into the host genome, cause an uncontrolled proliferative stimulus. This leads to a decrease capability in controlling the cellular surveillance mechanisms, with consequent accumulation of genetic abnormalities, increased genomic instability and the appearance of aneuploidy.
During the process of viral integration, part of the HPV DNA may be lost. However, this process never involves the E6 and E7 genes, so using a screening system targeting those genes exclude the possibility of false negative results due to viral integration events.

Ordering Information