HPV(HUMAN PAPILLAMOVIRUS) DETECTION

Genital infection with HPV is one of the most common sexually transmitted diseases (STDs) of viral etiology worldwide (20% - 46% in different countries in sexually active young women). Cervical cancer is the second most common cancer in women worldwide, and a compelling body of clinical, epidemiological, molecular, and experimental evidence has established the etiological relationship between some sexually transmitted HPV genotypes and cervical neoplasia throughout the world. Based on the frequency of detection of HPV genotypes from different grades of Cervical Intraepithelial Neoplasia (CIN Grades I – III), HPV genotypes are subdivided into Highrisk HPV types (16, 18, 31 and 45), Intermediate-risk types (33, 35, 39, 51, 52, 56, 58, 59, and 68), and Low-risk types (6, 11, 42-44).

Several methods have been used to diagnose clinical or subclinical infection with HPVs
including clinical observation, cytological screening by Pap smear, electron microscopy,
immunocytochemistry, but these methods have some disadvantages such as nonstandardization and subjectivity, insufficient sensitivity and low predictable value. The most perspective way of HPV diagnosis is a direct detection of DNA of the human papilloma virus of high carcinogenic risk by the polymerase chain reaction. While the value of the Pap smear in routine screening for cervical displasia is undisputed, it is now known that 99% of cases of cervical carcinoma are caused by infection with twelve genotypes of the human papillomavirus (HPV).

Identification of these high-risk genotypes is very valuable in the management of cervical carcinoma, both as a prognostic indicator and as a secondary screening test where results of a Pap smear are inconclusive. Results from the combination of the Pap smear and the HPV DNA test can aid in determining the intervals for screening. The PCR-based methods have been used successfully for the detection and typing of genital HPV genotypes in clinical specimens such as cervical swabs or scrapes, cervicovaginal lavages, frozen biopsies and formalin-fixed paraffin-embedded tissues.

HPV High Risk Screen is an in vitro Real Time amplification test for qualitative
detection of Human Papillomavirus (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59) in
the urogenital swabs Tissue and Liquid-based cytology samples.

HPV High Risk Type is an in vitro Real Time amplification test for qualitative
genotyping of Human Papillomavirus (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59) in
the urogenital swabs Tissue and Liquid-based cytology samples.

PRINCIPLE OF ASSAY
The Test is based on two major processes: isolation of DNA from specimens and Real
Time amplification in a 4 channel instrument. DNA primers directed against regions of
HPV A7, A9 groups (HPV types 16, 18, 31, 33, 35, 39, 45, 52, 58, 59), HPV A5 group
(HPV type 51), HPV A6 group (HPV type 56) and β-globine gene used as Internal
Control. The DNA Screen report will indicate the specific group to which the test
sample HPV belongs and the further genotyping will indicate which HPV genotype is
present.

This test is CE marked for Diagnostic Testing.

For more information on HPV click here